BRPI0905177A2 - sample preparation system for clinical sample processing - Google Patents

Abstract

SAMPLE PREPARATION SYSTEM FOR PROCESSING CLINICAL SAMPLES. The present invention relates to a system for the automated handling of test tubes containing samples of medical liquids. The robotic system processes the samples for further molecular analysis later. The processing comprises automated removal of the test tube cap, pipetting of the test tube contents, transfer of the test tube contents to a destination tray such as a multi-hole plate, and replacing the cap on the test tube.

Description

Report of the Invention Patent for "SAMPLE DEPREPARATION SYSTEM FOR CLINICAL SAMPLE PROCESSING".

FIELD OF INVENTION

The present invention relates to the processing of samples or clinical specimens. In certain aspects, the invention relates to the automated transfer of samples or specimens from an initial container or receptacle to a destination container or receptacle for further processing for the purpose of performing an assay or for the purpose of further analysis. . In other aspects, the invention relates to the transfer of portions of samples or specimens to a destination recipient container and the preservation of the remaining samples or specimens for further processing, testing, analysis, archiving, or other uses or purposes.

BACKGROUND OF THE INVENTION

With a growing need for medical diagnostics, increasing volumes of clinical specimens are being processed. Processing of clinical specimens or specimens may involve, among other things, transferring specimens or specimens to suitable recipients for diagnostic testing. Sample and specimen processing may include steps of accessing the contents of an initial container or receptacle, for example, by removing the liner, removing a portion of the contents, and transferring a portion of the contents to a destination container or receptacle. In some situations, processing may include replacing the lid, or otherwise closing, with an initial container or receptacle for the purpose of preserving the remaining contents for further testing or archiving.

Processing large quantities of specimens and specimens increases the time taken to provide diagnostic results, increases workers' exposure to repetitive motion disorders and potentially biohazardous materials, reduces the preparation consistency of the specimen. sample or specimen, and increases the costs of the diagnostic procedure. As the volume of medical diagnostic tests increases, the number of samples and specimens that require processing increases. Automating the sample preparation process for medical diagnostic testing addresses the issues identified above by reducing the time required to process specimens, reducing worker exposure to repetitive motion and biohazard materials, and providing consistency. sample processing, and helping to curb specimen processing costs.

BRIEF SUMMARY OF THE INVENTION

In one aspect, the present invention is an instrument or system for the automatic handling of medical samples for molecular analyzes. The instrument utilizes various arms and mechanical devices for manipulating test tubes or other receptacles containing specimen or medical or clinical specimen materials. In one aspect, the present invention consists of a method of automatic processing of medical or clinical specimens or samples for molecular analysis or other diagnostic analysis. In an illustrative embodiment, the present invention autonomously processes samples and cytological specimens for molecular analysis. Autonomous processing of samples and specimens may include accessing the contents of an initial container or receptacle, for example, by removing a lid or liner, removing all or a portion of the contents, transferring all or a portion of the contents. contents to a destination container or receptacle, and in some embodiments by replacing the liner, or otherwise closing, with an initial container or receptacle for the purpose of preserving the remaining contents for further testing. orfiles.

In one aspect, a sample preparation system (SPS) consists of a microprocessor controlled robotic device that automates the processing of clinical specimens contained in test tubes or other containers to destination receptacles for further processing and assay analysis. The SPS is capable of automatically processing large quantities of test tubes and other containers containing specimens or specimens. Microprocessor control can be implemented by any logic or processor that includes ASIC's, specialized logic or other integrated circuits. Automated control may be implemented by any logic or processor that includes specialized ASIC or other integrated circuits or any other combination of electrical-mechanical control devices.

Manually removing the cap from a test tube or other container for the purpose of transferring a sample to a target receptacle and then re-capping the test tube raises concerns for workers who would need to perform this repetitive task for a large amount of sample. test tubes or other containers. For example, clearing and manual retraining of medical or clinical specimens or specimens has the potential for exposure to hazardous materials, repetitive motion damage, fatigue, and reduced efficiency. SPS modalities are more adept at performing this repetitive task and reducing overall test cycle time, as well as reducing workers' exposure to potential disturbances caused by repetitive motion and biohazardous materials.

BRIEF DESCRIPTION OF VARIOUS VIEWS OF DRAWINGS

Figure 1. Top view of the sample preparation system.

Figure 2. Oblique view of the sample preparation system.

Figure 3A. Tip Head Mount

Figure 3B. Tip Head Mount

Figure 4A. Staging Platform Assembly (Carousel)

Figure 4B. Staging Platform Assembly (Carousel)

Figure 5A. Cover Hold Assembly

Figure 5B. Cover Hold Assembly

DETAILED DESCRIPTION OF THE INVENTION

In an illustrative embodiment, the SPS processes samples for a molecular diagnostic assay by uncapping a test tube, allowing access to the contents of the test tube, and pipetting a sample volume from the test tube and retamping it. if the test tube. Another additional embodiment of SPS includes pipetting a predetermined or specific volume of sample before the test tube is retracted. A test tube may contain a liquid sample, a control for a molecular diagnostic assay, a specimen to be tested in a molecular diagnostic assay, or a liquid-based cytological medium containing a specimen. The liquid-based cytological medium or sample medium may be a medium that is compatible with molecular analysis or a medium that holds and assists in the transport of specimens for other molecular or diagnostic analysis or for archiving. Archived samples can be stored and further tested. The SPS may use samples that have been previously sampled for other assays. Sampling of the samples by SPS after specimen processing allows for additional specimen storage and sampling.

The illustrative SPS processes a plurality of capped test tubes by shaking each test tube for the purpose of mixing the contents of the test tube or certain resuspended contents of the test tube by uncapping the test tube by pipetting an aliquot into the test tube. contents, and transferring this sample to a destination container for further processing. In another illustrative embodiment, the SPS processes a capped vial by uncapping the test tube, pipetting an aliquot of the contents, retorting the assay tube, and transferring the contents into a destination receptacle for processing. additional. In yet another illustrative embodiment, the SPS processes a capped vial by shaking the vial in order to mix the contents of the vial or certain resuspended contents of the vial by pipetting an aliquot of the contents. by recapping the test tube and transferring the contents into a destination receptacle for further processing. In other illustrative embodiments, the SPS processes a plurality of capped vials by chemically mixing or resuspending some or all of the contents of the vial before uncapping the vial to pipet an aliquot of the contents or separating them. the test tube components are chemically (eg, precipitation), physically (eg, centrifuged) or otherwise uncapping the test tube to pipet an aliquot of the contents. In still other illustrative embodiments, the SPS processes a plurality of chemically capped test tubes (e.g. chemical denaturation), physically (e.g. thermal denaturation) or otherwise treating the contents of the test tube. before uncapping the assay tube to pipet an aliquot of the contents.

The target or receptacle area may include any support or containment area that includes, but is not limited to, filter paper, blades, a multi-well plate, a multi-well filtration unit where liquid may be removed while retaining the medium. sample material, a tube arrangement, a tube rack, a filter unit arrangement, a filter unit rack, thermocycler plates, thermal cycler tubes, microarray, biochip, or any combination thereof. Any support or retention area that can handle an aliquot of specimens from an SPS-processed test tube or container is a suitable target area or receptacle.

Any specimen or specimen vial 12 or other container may be used in the sample preparation system. Any specimen vial cap may also be used in the sample preparation system. Suitable caps include screw caps, snap caps, or any cap that can be removed by the action of a cap arm. A specimen vial may include any vial or container that is capable of being handled by the SPS. . A specimen vial may contain samples, ranges, controls, washes, or any fluid or compound that

SPS can process.

In an illustrative embodiment, the medium used to collect and transport medical specimens may consist of any liquid medium which may preserve a biological specimen for molecular analysis at a later time. It is preferred that the medium consist of a liquid cytological medium. More preferably, this liquid medium can be used for both cytological and molecular specimen analyzes. A medium that can be used to preserve and transport a biological specimen is preferred. A medium suitable for preserving and transporting a specimen where the specimen is subjected to molecular analysis for microorganism determination is also preferred. Further, a medium in which the specimen is subjected to molecular analysis for determination of HPV, Chlamydia, Cytomegalovirus, HIV1 Treponema, and / or Neisseria is preferred.

In an illustrative embodiment, the SPS comprises a preparation carousel for test tubes or other containers during the de-capping and retraining steps and pipetting the contents of the test tube or container. Preferably, this preparation carousel comprises one or more test tubes or container cavities of one or more sizes for retention and grip of the test tube and other containers.

In an illustrative embodiment, a method for processing samples comprises transferring the test tubes to a preparation carousel such that a test tube may be uncapped, an aliquot removed, and retamped. In another illustrative embodiment, the method further comprises retaining the cap while an aliquot is being moved. In yet another illustrative embodiment, the removed aliquot has a predetermined amount.

Uncapping can be performed by one device wanting the cap while another device keeps the test tube sufficiently stationary to allow uncapping. For screw or twist caps, a disengagement device holds a test tube cap and rotates it such that the test tube cap is unscrewed or twisted from the test tube. During uncapping, the test tube may be held or rendered stationary by a test tube gripping device or by a passive device, thereby the test tube is held or rendered stationary by fitting a specially designed test tube. designed and / or snap-in or corresponding test tube cap retainer. Similarly, a screw cap or twist cap can be removed from a test tube based on a cap gripping device or a snap-in or corresponding test tube cap retainer, allowing rotation of the lid. The uncapping device also permits the retention of a cap during sample removal and the subsequent retreatment of test tubes.

Gripping the test tube may be accomplished by a device that holds a test tube in order to hold it or make it sufficiently stationary to allow removal of the test tube cap. In one embodiment, a test tube gripping device holds a test tube during uncapping and has the ability to release the gripping such that after retracing the test tube can be moved. An illustrative sample preparation system incorporates a test tube gripper which can hold or stationary any test tube, thus eliminating the need for a specially designed test tube.

In an illustrative embodiment, SPS pipetting is used to transfer a sample from a test tube to a target receptacle. The amount of sample that is pipetted may be determined by the operator, may be based on the size of the test tube, or may be based on the liquid level in the test tube as determined by a liquid level sensor. In all cases, a desired amount of liquid is extracted by mounting the specimen transfer pipette from an uncapped test tube and transferred to the destination receptacle.

Destination areas or receptacles may include, but are not limited to, filter paper, slides, microarrays, biochips, deep-well filtration plates and multi-well microplates, such as 96-deep filtration plates, 96-well microplates, 384-well filtration plates and 384-well microplates. Destination receptacles also include a pipe rack or pipe arrangement. A destination receptacle can be any suitable container that can accept and maintain an aliquot of a liquid specimen. Destination areas or receptacles may be located in a retention area 8.

In an illustrative embodiment of SPS1, samples loaded on top of SPS were previously sampled for analysis. Depending on the previous sample, the amount of sample in each container may vary from container to container. Therefore, the amount of specimens remaining in the specimen vial may be insufficient and should be determined. Prior to sampling, the SPS measures the amount of samples remaining in the container. The amount of samples can then be determined for sufficiency in performing a downstream assay. In addition, re-capping of the sample vials by SPS after sample removal allows for additional storage, archiving and testing of the sample.

Assemblies of an Illustrative Sample Preparation System

An exemplary embodiment of the sample preparation system may include one or more of the following subassemblies: Inlet Deck Holders 1, Inlet Deck 7, Mixing Basket 2, Test Tube Handling Arm 4, Prep Deck 3, Camping Arm 5, Tip Head Mount with Detect 9, Barcode Reader, Computer Control.

Entry Platform

The entry platform supports and moves several removable entry racks. In one embodiment, the inlet platform consists of a carousel and the inlet racks comprise the semicircular segments of the illustrative inlet carousel. These racks are fitted over a carousel connected to a drive mechanism, allowing rotation of the inlet carousel and inlet carousel racks. Input carousel rotation moves the samples contained in the input carousel racks, so they are accessible to the robotic test tube manipulator arm 4. The input carousel racks have a plurality of circular cavities sized to hold the test tubes. Each of the inlet carousel racks is removable from the SPS inlet carousel mechanism, where they are usually located at the top of the rotating carousel base. Removable inlet car sel shelves allow the rack to be loaded outside the SPS1 to secure and arrange the vials, and to store the vials after executions. Each inlet carousel rack comprises a semicircular segment of the entire inlet carousel where a full inlet carousel is formed when all inlet carousel racks are placed in the SPS. A smaller test tube rack 6 with a plurality of circular cavities serving to hold test tubes containing control solutions and comprising a smaller segment of the inlet carousel completes the inlet carousel of the SPS.

In alternative embodiments, one or more test tube inlets or racks may be wells with different shapes, sizes and dimensions relative to the specimen test tube in an SPS run or workflow.

In still other embodiments, the inlet platform and inlet platform racks are non-circular and can have any shape and can move in any way as long as the test tubes are accessible to the various components of the SPS. Additionally, in other embodiments, the inlet platform and inlet platform shelves may be stationary, with access to the test tubes using the SPS robotic arms.

Handle Test Tube Handler

Referring to Figures 1 and 2, the test tube manipulator arm 4 comprises a test tube gripping assembly mounted on a vertical steering mechanism that suspends and lowers the assembly. As illustrated in Figures 5A and 5B, in one embodiment, the test tube gripping assembly comprises three gripping fingers 23 equidistantly, radially and angularly spaced about a geometrical axis where the gripping fingers are capable of engaging. concentrically join for the purpose of grasping the cap of a test tube12. The vertical driving mechanism and the test tube gripping assembly are successively mounted on a stationary arm where a lateral driving mechanism moves the entire assembly along the arm length. This allows the test tube manipulator arm 4 to lower and grasp a test tube, suspend the test tube from its location and slide along the armrest to another location and lower and release the test tube in one location. different. The test tube manipulator arm 4 grasps and transports the test tubes between the inlet carousel, mixing basket, and preparation carousel. Test tube manipulator handles test tubes of any size and multiple dimensions in the same SPS execution or workflow.

Mixing Basket

Referring to Figure 1, the test tubes may be mixed using mixing baskets from the sample preparation system. The mixing basket comprises a basket for holding the test tubes and an eccentric drive mechanism for shaking the basket. The motor drive shakes the mixing basket and the test tubes it maintains, resuspending the contents of the test tubes. The test tubes may be mixed by displacement rotation of the mixing basket or by other known methods. The mixing basket may hold a plurality of different size test tubes.

Preparation Platform

The preparation platform comprises at least one cavity for holding a test tube and may comprise a plurality of cavities for retaining and gripping the test tubes. Illustrative OSPS incorporates a preparation platform in the form of a four-well preparation carousel. Each of the cavities contains a test tube gripping mechanism such that a test tube cap can be removed from a stationary test tube that is gripped by either cavity. A drive mechanism rotates the preparation carousel making the test tubes accessible to the robotic cap arm 5 and for removing an aliquot of contents. A plurality of test tube wells permit the handling of multiple test tubes and increases the number of processes that can be performed simultaneously, such as transfer of test tubes, uncapping / retraining of test tubes, and content pipetting. of test tubes. The preparation platform can be of any shape and need not be circular in shape or move. In an illustrative embodiment of the priming platform, the priming hopper is capable of rotating or moving the test tubes to provide access to capping arm 5, test tube handling arm 4, and / or the mounting of test tubes. specimen transfer pipette. A single motor or actuator drives a cam that tightens a test tube grip belt in the prep platform cavity. Rotation of the priming platform allows the test tube to be grasped in the selected well or wells and allows all wells to be capable of securing test tubes through the action of a single engine or actuator. Additional motors, actuators, or meat arrangements may be used to tighten the test tube gripping belt in more than one cavity at the same time.

In addition, the test tube gripping belt is wrapped around the cavity in a counterclockwise direction from a fixed end to a meat end mounted such that the belt has the property to be self-tighten during uncapping. Therefore, it can untap test tubes that have been tightened to a range of torques greater than the force limits of the camp. During retrofitting, the test tube grip belt configuration causes it to loosen to a predetermined torque setting ensuring that the cap is replaced at a consistent torque.

Camping arm

The test tube caps are removed and replaced by the cap arm 5. An illustrative embodiment of a camp arm 5 comprises a cap module shown in Figs. 5A and 5B mounted on an arm above the inlet platform 7. and the preparation platform 3. The module comprises a gripping finger assembly 23 securing the test tube cap, a finger drive mechanism 24 for opening the fingers, a rotational drive mechanism serving a to rotate the gripping finger assembly, and a vertical drive mechanism that serves to suspend and lower the gripping finger assembly. The grip fingers close by placing the three fingers together concentrically toward the center of the grip finger assembly via a finger drive mechanism 24. In alternative embodiments, the tamper manipulator may comprise two opposite fingers which are capable of to attach a test tube. For the purpose of accommodating the grip on a round cap, the fingers may be suitably shaped or made of materials that allow sufficient frictional contact between the fingers and the lid. Curved fingers, fingers that are flexible, fingers coated with an elastic material are some examples that will allow a two-finger cap manipulator to grasp a round cap. In other embodiments, the cap manipulator may comprise a finger assembly for grasping a test tube. This finger may also comprise a loop or strip which may be wound around a lid and with the side or strap fastening the lid is grasped. Loop or type tightening can be accomplished by rotating the finger / cap manipulator or shortening the loop or strip.

Uncapping a test tube is accomplished by rotating the preparation platform containing a test tube until the arm 5 is located above the test tube. The cavity of the preparation plate holding the test tube tightens to learn the test tube as the capping arm 5 folds, grips the test tube cap, and rotates to uncap cap.

Once a test tube is uncapped, the preparation platform may be rotated to the position of opening the test tube below the specimen transfer pipette to allow access to the contents of the test tube. As the contents of the test tube are removed, the cap may be held by the capping arm 5 until access to the sample contained in the test tube is no longer required. Re-capping of the vial is performed when the vial is properly located below the capping arm 5. The uncapping process is reversed and the vial retracted. Key parameters such as the torque applied to the lid, the insertion force of the lid, whether or not a lid is present, cross-threading etc. can be measured by the system sensors and can be adjusted by the operator and through the control program. workflow. The cap arm can cap / uncap test tubes of any size and multiple dimensions in the same SPS run or workflow. Test tubes containing performance controls often have different sizes than sample test tubes.

In addition to rotating the caps to uncap and hold the caps during other SPS processes, capping arm 5 is used to retract the vials and, while holding them, rotate them in such a way that a slide reader can barcode may bear the barcode label of the test tube.

Specimen Transfer Pipette Assembly

The specimen transfer pipette assembly comprises a demountable and suspendable nib head assembly 9 and a pipette arm 10 to which the nib head assembly is mounted and allows movement of the geometry axes X and Y and a detector 17. The pipette tip head assembly is piped to a pump that allows controlled intake and expulsion of liquid from the pipette. A detector or sensor 17 is attached to the tip head assembly 9 and allows measurement / detection of fluid levels in a test tube. Detector 17 can determine fluid levels through various methods such as optical, capacitive, impedance, vibration, pressure, radar / microwave, radio frequency, conductivity, resistance, or ultrasonic / sonic. Sensors that do not require contact with the sample can also be used to determine the location and presence of objects inside the SPS, such as disposable pipette tips, reagent bottles, waste bottles, and destination receptacles. Any combination of the various methods may be used through a detector or detectors for the purpose of measuring / detecting and / or determining the location of objects within the SPS. An ultrasonic detector is used in an illustrative embodiment of the SPS. Any ultrasonic detector may be used in this embodiment as available from Cosense, Inc., Haup-pauge, NY, USA.

Removal of the liquid sample from an uncovered test tube is performed using a pipette arm assembly that loads a standard disposable pipette tip onto the tip head assembly 9. The tip head assembly It is capable of moving at various locations in the SPS: collecting a pipette tip, removing a sample aliquot from the test tube, placing the aliquoted sample from the pipette into a sample processing tray or assay plate, and ejecting the tip used in a waste tray. A tip tip is retracted by moving the tip head assembly 9 downwardly over an available pipette tip, where it is held by tip head assembly 9 through friction with the nozzle 14.

Depending on the size of the vial, the level of liquids in the vial is determined before pipetting or before collection points. If sufficient liquid is present, based on measurements made by the ultrasonic detector, the contents of the test tube may be pipetted. Insufficient fluid levels will generate an error message. Exaggerated liquid levels will also generate an error message, as is generally indicative of sample tampering.

A microprocessor or programmable computer can be used to control all aspects of SPS operation. The test data is entered into the computer via a touchscreen monitor11, keyboard, and handheld and built-in barcode scanners. Each of the SPS subassemblies can be controlled by its own microprocessor or computer, including the previously detailed and Additionally, the pumping assembly, the heating mechanism, and barcode readers. A logic control circuit, microprocessor, central microprocessor, or any one or more combinations of the three may be used to control the subassembly of the SPS.

An SPS will have at least one between each of the previous components. However, additional copies of each of the previous components will increase processor throughput and may be used in SPS modes.

The input and function of the SPS data is entered using a touchscreen monitor 11, portable barcode reader and keyboard. The information is displayed on the front panel display 11 of the instrument. The information is processed by an integrated microprocessor and stored locally and can be stored on network devices. Additionally, a barcode reader can be added or replaced with an RFID reader and the use of RFID labels. Operation of an Illustrative SPS

The following describes the typical functions performed by an illustrative SPP for processing a single test tube.

After a program has been initiated, the test tube handling arm 4 moves toward the input platform rack 1 so as to obtain a test tube. The test tube handling arm4 lowers, grips and lifts a test tube, which is then positioned in the mixing basket. The mixing basket resuspends the contents of the test tube. Test Tube Handling Arm 4 removes the agitated test tube from the mixing basket and places the test tube on a four-well preparation platform.

Rotation of the prep platform moves the test tube to a position accessible to cap arm 5. Cap cap arm 5 lowers to grasp the test tube. If the test tube label is not read by the primary barcode scanner that blocks the test tubes as they are transported from the inlet platform 1 to the mixer, the test tube is pulled from the well platform cavity. preparation and rotated in front of a barcode scanner to read the label and then returned to the prep platform cavity. Although the capping arm 5 is kept in the test tube cap, the preparation platform grasps the test tube, immobilizing it sufficiently. The cap arm 5 rotates and removes the cap from the test tube. With the assay tube cap removed, the prep platform rotates to allow a sample to be removed from the test tube.

The specimen transfer pipette assembly moves tip-tip assembly 9 to a pipette tip storage box in retention area 8 and collects a pipette tip. With a pipette tip in position, the specimen transfer pipette assembly moves over and above the uncapped test tube. The ultrasonic volume sensing sensor in the specimen transfer pipette assembly determines the surface height and content sufficiency of the uncovered test tube contents. The pipette tip head assembly is lowered into the test tube and aspirates a measured amount of sample. A predetermined volume of sample is extracted at the pipe tip using a volumetric pump in communication with the tip through a tube. The tube and the volumetric pump may preferably be at least partially filled with a substantially incompressible fluid, such as water, and preferably only have a portion of the tube to create an interface. between the sample drawn at the pipette tip and the hydraulic fluid in the tube. Preferably, this arrangement assists in extracting a precise and predetermined volume of liquid by reducing the total compressibility of the gas and liquid in the tubule that is used to extract the sample. Other means for extracting a predetermined volume include measuring the liquid level using a fluid level sensor as a sample is extracted or by measuring the liquid level before and after extracting a sample.

With an aliquot of sample contained in the pipette tip, the specimen transfer pipette moves to a target plate where the specimen is dispensed into a well of the plate. The specimen transfer pipette then moves and dispenses any remaining fluid from the system waste bottle. After all liquid is expelled, the specimen transfer pipette moves to the tip waste picker where the used pipette tip is removed.

After an aliquot of the contents of the test tube has been sampled, the prep platform moves to the retraining position. The vial cap that was held by the capping arm 5 during aliquot sampling is attached to the vial. Once the vial is retracted, the vial moves to the position. collection of test tube. Test Tube Handling Arm 4 lowers, grabs the test tube, lifts the retreated test tube and returns it to its rack cavity location

from the original entrance platform.

Because capping arm 5 holds the test tube cap during aliquot sampling and does not place the test tube cap on a surface, no cross-contamination of the samples occurs through contact with the test tube cap. By eliminating cross contamination, retreaded vials can be stored, archived and resampled.

Rotation of the input platform rack 1 advances other test tubes to a position to be processed. Several of the above operations of the SPS can be performed at the same time on multiple test tubes, which include transfer of test tubes, resuspension of test tube contents in the mixer, uncapping / retorting, and aspiration / dispensing. Upon completion of a run, the volume of the sample dispensed into each target receptacle can be serviced by the ultrasonic detector scanner to the correct volume.

EXAMPLE 1

An illustrative sample preparation system comprises an inlet platform serving to hold a plurality of test tubes. The inlet platform is shaped to receive individual removable segments where the test tubes may be loaded prior to the placement of the inlet rack segments in the processor. Up to 88 20ml test tubes containing specimens collected in a collection medium or 176 10ml test tubes containing specimens collected in a transport medium may be loaded into the input rack and placed on the instrument input platform for storage. processing, including transport to the appropriate destination plate (s). Sample or specimen medium may be PRESERVCYT or SPECIMENTRANSPORT MEDIUM. Target plates may be 96-well microplates or 96-well deep filtration plates, depending on the amount of specimen. Typically, samples from the 20 ml test tubes may be processed onto the deep well filtration plates while samples from the 10 ml test tubes are processed onto the microplates. The inlet platform and inlet platform shelves need not be circular and can have any shape and can move in any way such that the test tubes are accessible to the various components of the SPS. Additionally, the entrance platform and the entrance platform shelves can be stationary, with access to the samples provided by the robotic arm movements.

In operation, a test tube manipulation arm 4 moves up to an inlet platform 7 containing calibrator / control or sample / specimen. The test tube handling arm 4 grasps and suspends a test tube, which is then positioned in a vortex mixer. The vortex mixer resuspends the contents of the test tube. After vortex mixing, the test tube handling arm4 places the test tube on a four-well prep platform 3. During passage to the prep platform 3 through the test tube manipulation arm 4, the test tube bars can be read by a barcode scanner positioned between the input platform 7 and the preparation platform 3. Rotation of the preparation platform 3 moves the test tube in a position accessible to a capping arm 5 .

If the barcode of the test tube is not read previously, the capping arm 5 grasps the test tube, pulls it from the preparation platform cavity 3, if necessary, exposes the code bar in the test tube, and rotates it, allowing the barcode scanner to typically read the barcode over a test tube label. After placing the test tube back into the preparation platform cavity, a belt is tightened or tensioned around at least a portion of the circumference of the test tube to stabilize the test tube on the preparation platform 3 while the capping arm 5 grasps. cap the vial and remove the cap from the vial by rotating the cap in an open direction. After the assay tube cap is removed, the prep platform 3 rotates the assay tube out from the bottom of the cap arm 5 to allow access to a specimen transfer pipette for the purpose of removing the sample. or specimen from the test tube. The capping arm 5 holds the cap while the specimen or specimen is removed from the test tube.

Tip head assembly 9, mounted on an X-Y-Z 10 robotic arm, moves to tip box, lowers tip head assembly into a disposable specimen tip preparation area, and collects a disposable specimen tip. A sensor confirms that the disposable specimen tip has been successfully collected. With the disposable specimen tip in position, the tip head assembly 9 moves over the uncapped test tube on the prep platform. An ultrasonic volume sensing sensor in the nose head assembly 9 determines the surface height and volume sufficiency of the uncapped test tube contents. Since samples to be processed by SPS may have been previously sampled for analysis, measuring the remaining sample quantity allows sample tracking. The specimen transfer pipette mount lowers the 9-tipped head assembly until the disposable specimen tip is below the specimen of the test tube and aspirates a portion of the specimen or specimen. With the sample contained in the disposable tip Specimen transfer assembly moves the tip head assembly to a target plate where the specimen is dispensed into a plate cavity. The nose head assembly then moves and dispenses any remaining fluid into a system waste bottle. After all liquid is expelled, the tip head assembly moves to a sensor that confirms that the disposable specimen tip does not enter the passageway and ejects the disposable specimen tip into a tipped waste picker.

After a specimen is removed, the prep platform moves to a reclosing position. The vial cap that was held by capping arm 5 during sample removal is placed back into the vial by rotating the cap in a closed direction. Once a vial is retracted, the vial moves to a vial retract position. Then the vial manipulator arm 4 lifts the vial and replaces it into the inlet vial position. calibrator / control or original specimen. Rotation of the inlet platform advances other test tubes to the position to be processed. After aliquot sampling, all samples are retamped and returned to the input platform for storage, archiving, and / or resampling for further testing.

Upon completion of a run, the sample volume dispensed on each target plate can be verified by the ultrasonic detector that scans the target plate for the correct volume.

Several of the above SPS operations can be performed at the same time on multiple vials, including vial transfer, barcode scanning, resuspending the vial contents in the mixer, uncapping / retraining, aspiration. / dispensing, and volume confirmation.

Sample and specimen processing is controlled by an operator through a central graphical user interface (GUI) control that controls the functions of the SPS. This allows selection of plate number, plate layout, mixing time / speed, suction / dispensing volume, and other test protocol and operator control parameters.

Once the processing program has started, sample processing continues until completion. Error recovery sequences are incorporated into each step of sample processing and automatically resolve any mechanical problems during a run or, if operator intervention is required, interrupts the moving of the instrument parts and an audible alarm and visual message will be displayed. the purpose of attracting the operator's attention.

Several operator selectable workflow programs are available in SPS. These workflow programs specify the parameters that govern the arrangement of the plates and transfer the processes, including parameters such as the destination receptacle type, calibrator / control parameters (for example, type, number). external control parameters (eg type, min / max ratios,% CV. Destination receptacle arrangement (eg location in receptacle for calibrators / controls, specimens designated for initial or retest testing, controls)). test tube size, cap type, mixing time and speed, suction / dispense volume, retest replicates, as well as whether or not manually piped specimens are allowed.

Workflows are specific to a test protocol, specimen type, and processing method. New workflows can be added to the SPS as new test protocols are developed. Standard workflows can be created by an operator to meet unique laboratory testing requirements. More than one workflow can be selected for the same specimen type and can be selected for an SPS run. As an example, Digene High Risk HPV and Low-Risk HPV protocols can be performed for specimens.

SPS tracks integrated consumables such as system fluid bottles, reagent bottles 13, system waste bottle, environmental hazardous waste bottle, tip boxes (for example, number of tips and tip boxes required for complete the workflow selected by the operator) and tip waste. Generally, before a workflow begins, SPS can notify the operator if consumables need to be filled or if bottles and tip debris need to be emptied.

The SPS can stimulate the operator by loading calibrators, controls, and specimens, including stimuli to: scan calibrator barcodes and control test tubes, load calibrators / controls onto an input platform, scan barcodes from pla - input forms containing specimens (eg confirmation of platform type to expected specimen type), load input platform racks onto plane, load target plate (s), and confirm identity of plate destination through the barcode or other identifier.

Positive identification of various processing components is accomplished through computational tracking of calibrators, controls, specimens and plate identification numbers. Specimen rack identification, specimen rack position, plate identification, and cavity position are associated with specimen calibrator, control, and identification. This information is shared with other automated and / or downstream automated molecular testing systems for complete tracking of the specimen dispensed into the test tube and the measured result to the specimen.

Operator input, control, specimen rack, and plate identification prior to loading can be entered using an external portable barcode scanner. The ID can also be entered using the retractable keypad on the front of the instrument. The SPS internal barcode scanners read the identification when transporting the test tubes from the inlet platform to the preparation platform.

Once execution is complete, the SPS transfers a file containing a map of the destination board that matches the processed samples to downstream SPS instruments or networked servers or drives. Cards processed by the SPS are then removed for further processing.

Data is transferred between one or more SPS and one or more control analyzers, or molecular analysis system computers (for example, PCs), connected to a network where data is placed on a shared network server or data disk, which may include identifications. specimens that require retesting, assay protocols, workflows, external controls added to molecular analysis system software and auxiliary data sharing with downstream molecular assay systems. Molecular analysis system controllers, analyzers, or computers (for example, PCs) may receive the network or disk server for target card map files. OSPS further comprises a USB port for data copying and / or manual transfer of target card map data to molecular analysis system controllers, analyzers, or computers (e.g., PC). During operation, SPS automatically records execution history and error events. Therefore, by tracking sample placement software, one can maintain the chain of custody.

Cervical specimens to be analyzed for HPV by a molecular diagnostic assay such as HYBRID CAPTURE 2 (HC2) can be either manually processed or automatically processed using the RAPID CAPTURE SYSTEM instrument. In addition, various test tube containers with different types of screw caps may be used, with the capping arm 5 capable of removing the cap, retaining the cap, and retraining the test tube.

SPS consists of a component in a scalable test system. It functions as a standalone unit, such as a module in a network configuration with one or more SPSs, as a module in a full laboratory automation system, or in other systems that contain multiple components. As an example, additional devices such as downstream automated molecular testing systems may be included in a network or system.

In order to increase the throughput of sample processing, the SPS can read barcodes and other identifying information on test tubes as they pass from the inlet platform to the vortex mixer, or from the vortex mixer to the platform. preparation method for removing the cover. In an illustrative SPS, although the test tube is held by the test tube manipulation arm 4 and moves toward the preparation platform, the test tube passes through a bar code reader that reads the bar code from the test tube. test tube. In this way, the reading of the barcodes may be facilitated by orienting the barcodes on the entrance platform shelf during the operational loading of the test tubes. The markings are located on the entry platform shelves to assist in the orientation of the test tube barcodes so that they can be easily read by the barcode reader. If the specimen vial bar code is not ready before it reaches the primer platform, capping arm 5 will retract the vial after it has been placed in a prep platform cavity and will rotate it so that a barcode reader can read it. In order to increase sample handling performance, the orientation of the sample bar code alignment can be automated. The automation may comprise test tube pins or indentations such that only a particular test tube orientation is optimal for barcode reading to be possible on the inlet platform.

EXAMPLE 3

In one of the sampling processing operations of an illustrative SPS, there may be a need to further disperse a specimen prior to removing a sample from the uncapped assay tube. In order to assist in this process, several different approaches may be required to ensure proper dispersion and distribution of the specimens.

A reagent may be added that helps to disperse the specimen to the test tube contents. Such a reagent would ensure that sufficient specimens were resuspended and could be aliquoted. After a test tube is uncapped, a measured amount of dispersion reagent is pipetted from a reagent bottle 13 added to the test tube, and the retested vial. During addition of the dispersing agent, the sample may be hydraulically mixed through repeated suction and expulsion from the suspension. An aliquot can be removed after hydraulic mixing and can be transferred to a destination receptacle. If additional mixing is required, the retreated test tube is placed in the vortex mixer and shaken. From this point, the test tube can be uncapped and an aliquot transferred to a destination receptacle. If time is required to allow the reagent to react any time after the reagent has been added, the retreated assay tube may be returned to the inlet platform and allowed to incubate while another test tube is processed. The steps described above may vary and their duration is controlled by the SPS computer running the workflow program.

The reagent may be any solution suitable for dispersing a medical or cytological specimen. Suitable reagents include, for example, any strong base, such as NaOH 1 KOH and LiOH. The reagents may also include various detergents such as SDS1 TRITON X-100, Brij-35, TWEEN-20, NP-40, and octyl glucoside.

EXAMPLE 4

In an automated diagnostic system, disposable pipette tips of various volumes of samples or specimens are used for the purpose of facilitating the use of various sizes of sample or specimen vials and containers, and to prevent persistence of sample residues. In an illustrative sample preparation system, the disposable pipette tips are accurately collected, sealed to the tip head assembly, and retained during aspiration / dispensing of various fluids removed by the sample preparation processor.

A self-centering tip retention mechanism aligns the tip-tip assembly with the disposable pipette tip to precisely center the disposable tip-tip assembly before the tip-head assembly is lowered to the tip. collect a disposable pipette tip. (Figures 3A and 3B). A spring-loaded compliance system 16 is constructed in the headstock assembly to allow the stepper motor to insert the nested flap 14 beyond the expected stop. This ensures a fluid-tight seal when attaching the nested nozzle tip to a disposable pipette tip without loss of step from the stepper motor or damage to the disposable tip.

A slidingly mounted alignment collar attached to the nested nozzle tip 14 of the tip head assembly helps align the nested nozzle tip 14 to a disposable tip. The collar is straightened using a shoulder thread and slides along the nozzle tip when the disposable tip is not in position. When the specimen transfer tip restores a disposable tip, the alignment neck having a tapered edge receiver aligns the disposable tip inside the tip head of the tip head assembly9 by engaging the disposable tip. Collar 15 corrects any major misalignments of the nose assembly prior to engagement of the disposable tip by the nested nozzle 14, and a chamfered edge of the nozzle 14 corrects any minor misalignments.

The nozzle tip is compatible with a spring 16 used to keep the nozzle tip extended. As the nozzle tip restores a disposable tip, the nozzle compresses by applying a certain amount of force to the disposable tip creating a fluid-tight seal without loss of engine steps and disposable damage.

Other methods of disposable tip alignment that can be used in illustrative sample preparation systems include a tapered edge of the nozzle tip barrel or a chamfered edge. This tapered or beveled edge helps guide the 9-headed assembly to the disposable pick-up tip. The use of filtered disposable tips limits the amount of taper that can be used to meet such a tip. This makes alignment more difficult when sealing the disposable tips filtered from a disposable rack.

Alignment collar 15 is also used on pipette ejection tips. The pipette tips are ejected from the nib head assembly 9 when the alignment collar is placed under two upper edges of the disposition rail 18 followed by the XYZ arm 10 which raises the tip head assembly 9 in the Z direction. Although the alignment collar 15 is held by the edges of the disposition rail 18, force is applied to the pipette tip by the alignment collar 15 from the upward movement of the nested nozzle tip 14 with the elevation of the tip head assembly 9. nested nozzle tip 14 drags freely from the pipette tip, which enters the waste picker below.

EXAMPLE 5Staging the Preparation Platform

In an illustrative sample preparation system, the preparation platform works in part by holding a test tube in its wells through a strap to prevent the test tube from rotating or exiting the well during uncapping. and the camp (Figures 4A and 4B). A known pressure / force is applied to the belt to maintain the test tube and prevent it from twisting or being lifted.

In medical diagnostics, various sizes (e.g., diameters) and container shapes containing various types of samples are used, and specimens, typically in the form of a fluid or as solids or other material suspended or stored in a container. fluid. Such samples and fluid specimens shall be safely stored in the test tube or container and securely accessed for transfer to a destination receptacle or other processing. A test tube is secured such that the sealing cap can be safely removed and reapplied without spillage during specimen recovery. Automated uncoupling and retraining prevent spillage before and after retrieval, transfer, or processing of specimens or specimens.

In the prep platform 3, a spring mounted on a belt cam 21 prevents the belt 14 from prematurely approaching the test tube or an empty cavity. After a test tube is placed in the sample retention cavity of the prep platform, a motor 22 is applied that applies a force to the tightened belt cam tensiones the belt around at least a portion of the circumference provided with the test tube. test. The belt is advantageously mounted in a direction that allows it to tighten or tighten as a test tube is popped. When the force is reversed or when the cap is replaced on the test tube, the belt slides around the test tube after a certain force has been applied.

When the preparation platform prevents the test tube from rotating, a motor applies force to a meat that tightens the belt around the test tube. This force applied to the belt is limited by using a spring attached to the motor support that pivots when a particular force is applied. Attached to the end of the motor shaft is an actuator cap that contacts the belt cam that tightens or tightens the belt around at least a portion of the circumference of the test tube. When a certain force is reached, the actuating bracket to which the motor is fixed begins to rotate, applying a compressive force to the spring that drives a sensor.

A preparation platform can also hold test tubes or containers by various other methods. A clamping mechanism can secure the test tube. The test tube or container may be forced against the platform cavity wall by a rod, stem, plate, or strip. The test tube is held by the force of an object that is pressed against it within the cavity perpendicular to the circumference tank of the test tube. With special indentations or pins in the test tube / container, a cavity with indentable surfaces or pins would keep the test tube / container stationary.

EXAMPLE 6

Cover Hold Assembly

In an automated diagnostic system, test tubes of various sizes are generally capped to retain fluid specimens for transport from the clinical or test site to the analytical laboratory. These caps should be removed to suck up the fluid contained in the test tube. After a quantity of fluid has been removed using a certain amount of force, the cap may be retightened to the test tube to prevent fluid from being spilled and to preserve the sample or specimen for further testing, retesting or archiving. .

The cap gripping mechanism of an illustrative sample processing system holds a test tube cap through a spring / sensor feedback system (Figures 5A and 5B). Gripping strength can be a constant force, but it need not necessarily be constant as long as the force is sufficient to perform the unblocking and retraining processes. A lid is secured via the clamping arm gripping mechanism 5. The gripping mechanism exerts a force on the lid at three points in order to restrict the lid in the theta direction. Restriction of theta lid cover allows the lid to be uncapped and retracted.

The gripping mechanism comprises an upper and lower housing in which the bearings are pressed. Between the compartments are three output shafts that are supported by the bearings. Each shaft has a gear 25 and centrally located is a gear 26 that engages each of the output shafts to provide synchronized movement. A gear motor 24 with a pinion gear drives the gears and applies torque to the output shafts. Three gripping fingers 23 are attached to the output shafts. Each pressure finger has a pin (toothed or knurled, depending on the application requirement) that interfaces directly with the lid and applies a normal force along this interface.

Rotation of output shafts allows gripping fingers to open and close. Motor torque is transmitted to the fingers through the gear assembly. When fingers touch a relatively immobile object such as the lid, the reaction torque is limited by a torque sensor. This torque sensor is a torque sensor that changes the state when the moment on the arm exceeds the force of a bounding spring. The torque at which the sensor is actuated is directly proportional to the hardness of the limiting spring. The gear motor is mounted on a pivot that passes through two support bearings and allows the motor to freely rotate around its geometry axis. The pivot has an arm that extends from the center and to which a spring is attached. The other end of the extension spring is fixed to the top of the housing. With spring precariousness applied, the arm is against a sudden stop. In this position, an optical switch is blocked by the presence of the arm. When the gripping fingers are in contact with the cover, movement is limited as a result, the motor positions your pivot against damola force. The optical sensor detects arm movement. In this way, lids of any size can be fastened tight enough to carry out the uncapping and backing processes without crushing the lid. The cap gripping mechanism can be used to uncap and uncap different size test tube caps and allows the SPS to handle different size test tubes during the same run or workflow.

EXAMPLE 7

Sample Temperature Control

Temperature control of samples to be processed is performed using heating / cooling humidity. These units are located below the inlet platform, inlet platform, in the target receptacle retention area, and / or anywhere inside the SPS to facilitate temperature control. Methods of heating and / or cooling samples may be performed using heating elements, water circulation, hot air, and Peltier effect elements.

Similarly, the reagents can be heated or cooled within the SPS, providing optimum temperature conditions for sample preparation reactions. Reagents may be heated and / or cooled through the use of heating elements, water circulation and Peltier effect elements.

Heating and / or cooling temperatures are monitored and under the control of the computer. Sensors that serve to monitor temperatures include IR sensors, thermoelectric pairs, thermosistors, and semiconductor thermometers.

EXAMPLE 8

Chemical separation of the sample components of a test tube may include precipitating agents, such as ethanol, methanol, ammonium sulfate, polyethyleneimine, polyethylene glycol, and antibodies (immunoprecipitation). Sample components may comprise cells, nucleic acids, viral particles, microorganisms, and / or proteins. Physical separation of samples may include centrifugation, filtration, agglutination to a matrix, such as polyvinyl or nitrocellulose difluoride, agglutination to silica beads, agglutination to magnetic silica spheres, agglutination through antibody-coated silica spheres, or permitting them to contents of the vial decant. Test tube or container caps may be used to aid in specimen concentration and removal of the preservative.

EXAMPLE 9

An example of a molecular diagnostic assay may be an assay where information useful in determining an individual's medical condition may be obtained using molecular biological methods which include, but are not limited to, nucleic acid hybridization, antibody agglutination, ELISA. , nucleic acid amplification, nucleic acid purification, nucleic acid sequencing, antigen or protein purification, protein sequencing, enzymatic treatment of nucleic acids, restriction enzyme digestion, enzymatic treatment of nucleic acids or proteins, blotting nucleic acids or proteins, measurement of enzymatic activity, chemical modification of nucleic acids, labeling of nucleic acids, chemical modification of proteins, and protein labeling. Accordingly, an example of a molecular analysis may be an analysis using molecular biological methods as described above.

An example of a specimen may be any material collected from a patient. This material includes, but is not limited to, all possible body secretions, fluids, cells, tissues, metabolites, and naturally occurring or synthetic compounds. Microorganisms, which include bacteria and viruses associated with any of these materials, may be understood to be a specimen.

An example of a capped vial may be a container with a corresponding cap, thereby the cap provides sufficient sealing to prevent a liquid contained in the capped container from leaking, and thus the cap may be removed and replaced. repeatedly to allow repeated access to a sample. The test tube and cap may be any suitable material which may contain a liquid that will be used on a patient specimen. The vial and cap do not require any special indentations, extrusions, indexing, or reference markings to allow repeated vial uncapping and retesting through the illustrative SPS.

The foregoing description of the various illustrative embodiments has been given for purposes of illustration and description. The same is not intended to be exhaustive or limiting to the precise forms described. Obvious modifications or variations are possible taking into account the previous teachings. The modalities discussed have been chosen and described to provide illustrations and their practical application in order to allow a person skilled in the art to use the various and various modifications as appropriate for the particular contemplated use. All modifications and variations are within the system determined by the appended claims when interpreted according to the extent to which they are fairly, legally and correctly entitled.

Claims (10)

1. Test tube processing system comprising: an inlet platform adapted to receive a test tube, a preparation platform adapted to receive a test tube, a test tube manipulator positioned to transfer a test tube between the input platform and preparation platform; a lid manipulator positioned to engage and remove a cap from a test tube on the preparation platform; a test tube clip to restrict movement of the test tube during cap removal; a transfer pipette assembly comprising a pipette arm, and a tip head assembly, the tip head assembly being mounted on the pipette arm and adapted to receive a tip of tip, the pipette arm being positioned to translate the head assembly tip between an open vial and a target area. The test tube processing system of claim 1, wherein the transfer pipette assembly further comprises a vacuum generator in communication with the tip head assembly for withdrawing a predetermined volume of liquid from a test tube. . A test tube processing system according to claim 1 further comprising a mixing basket adapted for receiving a test tube and wherein the test tube manipulator is additionally positioned to transfer a test tube between the inlet platform; the preparation platform and mixing basket. The vial processing system of claim 1, wherein the inlet platform is adapted to receive a vial rack having a plurality of holes adapted to receive a plurality of vials. A test tube processing system according to claim 4, further comprising two test tube racks, wherein the holes of a first test tube rack are adapted to receive a first set of test tubes and the holes of a first test tube. The second test tube rack is adapted to receive a second set of test tubes, and wherein the holes in the first test tube rack have a different set of hole sizes than the second test tube rack. The test tube processing system of claim 1, wherein the test tube rack comprises a belt attached to the preparation platform at one end and connected to a clamping lever arm at the opposite end to form at least one end. at least a partial loop for receiving a test tube whereby the belt tightens around a test tube disposed in the loop when the force is applied to the lever arm. A test tube processing system according to claim 1, wherein the cap manipulator comprises at least two fingers extending parallel to and substantially equidistant radially and angularly from a central geometry axis, and a torque sensor to detect the force of the fingers into a vial cap being triggered, whereby the cap manipulator is capable of engaging variable size vial caps. The test tube processing system of claim 1, wherein the tip head assembly is substantially aligned parallel to the longitudinal geometric axis of a tip head and comprises a collar, a beveled nozzle tip and a liquid level measurement sensor, wherein the collar is slidably attached to the nozzle tip and wherein the nozzle tip is concordant in the longitudinal sense. 9. Automated test tube processing system comprising: a microprocessor, an input carousel for receiving a plurality of semicircular test tube racks wherein the test tube racks have a plurality of holes sized to receive a plurality of tubes. wherein the microprocessor is in functional communication with the inlet carousel and is capable of controlling the rotary motion of the carousel; a mixing basket having a bore sized to receive a test tube; wherein the microprocessor is in functional communication with the mixing basket and is capable of controlling mixing of the contents of a test tube, a preparation carousel having a plurality of holes sized to receive a plurality of test tubes and wherein The microprocessor is in functional communication with the preparation carousel and is capable of controlling the rotary movement of the carousel; an outlet comprising a strap having a first and second end and being disposed within each preparation carousel, a lever arm having a first and second ends, and an actuator, wherein the first running end is connected to the preparation platform, the second The end of the belt is connected to a first end of a clamping lever arm, and the actuator is arranged to communicate with the second end of the lever arm, wherein the microprocessor is in functional communication with the actuator and is. capable of controlling actuator coupling with lever arm and belt clamping and releasing in a test tube, a test tube manipulator positioned to transfer test tubes between the inlet carousel, mixing basket and carousel where the microprocessor is in functional communication with the test tube manipulator and is able to control the movement of the test tubes. testing between the inlet carousel, mixing basket and preparation carriages: a cap manipulator positioned to engage a cap on a test tube and to remove and reapply the cap to the test tube, wherein the cap manipulator comprises at least at least two fingers parallel them to substantially radially and angularly equidistant from a central geometry axis, and a torque sensor to detect the force of a finger on a vial cap being engaged, whereby the handler cap is capable of engaging test tube caps of varying size, and wherein the microprocessor is in functional communication with the cap handle and is capable of controlling coupling of the cap manipulator with a cap of test tube; a transfer pipette assembly comprising a pipette arm, a tip head assembly, and a vacuum generator pump, tip head assembly being mounted on the pipette arm and adapted to receive a disposable pipette tip, the pipette arm being positioned for translating the tip head assembly between a pipette tip storage area, an open test tube, a target plate, and a pipette tip discharge area, where the tip head assembly is aligned in parallel. to the longitudinal axis of a tip head and comprises a collar, a beveled cal-tip and a liquid level sensor, wherein the collar is slidably joined to the nozzle tip and wherein the tip nozzle is longitudinally agreed, and wherein the microprocessor is in functional communication with the transfer pipette assembly and is capable of controlling the movement of the nozzle head assembly. It is located between the pipette tip storage area, open test tube, target plate and pipette tip discharge, and is capable of controlling the operation of the vacuum generating pump to withdraw a predetermined volume of content. of a test tube. 10. Method for processing the vial contents which comprises the steps of: placing a vial on an inlet platform adapted to receive the vial; transferring a vial from the input platform to a preparation platform adapted for receiving a test tube using a test tube manipulator positioned to transfer test tubes between the inlet platform and the preparation platform under the control of a microprocessor, trapping the test tube in the preparation platform to prevent rotary motion and while attaches the vial, removing a vial cap using a cap manipulator positioned to engage and remove a cap from an assay tube under microprocessor control, cap retention on the cap manipulator while removing a predetermined volume vial contents of the uncapped test tube using a pipette assembly from which with holds a pipette arm and a tip head assembly, the head assembly is mounted on the pipette arm and adapted to receive a pipette tip, the pipette arm being positioned to translate the tip head assembly between a tube open test tube and a test tube content area under the control of a microprocessor; unloading the predetermined volume of pipette index into a target plate under the control of a microprocessor; and replacing the test tube cap after the predetermined volume of content has been removed from the test tube under the control of a microprocessor.