WO2017189948A2 - Plate reader calibration, secure operation, and improved peel plate - Google Patents

Abstract

Reader and plate methods, operations, and systems for imaging/counting biological development on plates are shown and described. One embodiment Includes calibrating a plate reader. Calibration may be triggered by detecting a quality control event or the like. The calibration process may include receiving a low and/or high calibrator, counting objects on. The calibrator(s)s and comparing objects on the calibrator(s) to a predetermined limit. The result is an improved plate reader for observing biological growth, when present, on a growth plate.

Description

PLATE READER CALIBRATIO ), SECURE OPER TION, AND IMPROVED FEEL PLATE This■application claims the ^"benefit of U.S. provisional application number

62/32S665₅ filed April 28, 2016; U.S. provisional application number 62/3325?!, filed May 6^", 2016; and U.S. provisional application number 62/362703, filed July 15, 2016, all of which are incorporated herein by -reference in their entireties,

Field of the Teckriol gy

The present disclosure relates generally to biological testing, and more

•particularly to improved methods and operation of plate readers.

Background

It is desirable to provide rapid, effective detection and dentification of vari us and numerous nficroorgariisnaa in test samples, such as samples of water, food, such as milk, and body fluids. Microorganisms of interest include ail aerobic bacteria and specific .bacterial groups, such as coliforms > Other microorganisms of interest .include^' a variety of yeast, molds, and the like.

Classical methods fdr euituring ^'.various microorganisms For detection and identification thereof Include the spread plate method, the pour plate -method and the liquid medium method. Irs t ese traditional methods and devices, biological testing is used to identify and quantify, the presence of biological matter in samples. Often, these results are us d to diagnose biological concerns and begin remedial measures.

Particularly in the food industry, where testing is very ^'cost-sensitive,, early and accurate diagnosis is desired. In addition, reducing hurnan error is desired, particularly where users might not he laboratory-trained technicians. Tests used must, therefore, ^"be- ser- f iend and inexpensive without sacrificing accuracy. Further., conventional systems arid methods fail to ensure proper and efficient calibration, security measures, and acti vation of testing devices and procedures.

Therefore, Applicants desire reader calibration and secur y systems, met ods, and qualit control devices and operations witfao«tihe dra backs presented by the traditional arrangements.

Irs. accordance with the present disclosure, methods of ^'calibrating and operating improved plate readers are provided, to monitor biological development. This disclosure provides improved methods and devices that are convergent, -ffie en , and safe for the nser, particul ly when used to calibrate add activate plate readers to identify biological development, for instance counting microbial colonies, when present.

Irs one embodiment a method of negative ealihraiion of a plate reader comprises triggering a calibration activation; inserting a low calibrator within tbe plate reader; imaging the low calibrator; and counting image counts, wherein counting: less Chars about four image counts, or an predetermined count nun ber, generates a valid determination and counting greater than about four image counts, or any predetermined count number, generates an .invalid, determfnation,

tn. particular examples, inserting the low calibrator includes aligning a low .calibrator plate about a sunken support frame. Aligning the lo calibrator plate may include positioning a pair of opposing plate pnsximate apertures in a pair of

corresponding proximate frame■ apertures, and positioning a distal plate platform in a corresponding distal feame. platform aperture. A negative calibration cheek may be triggered, on a first count of a startup event. Triggering the calibratio check may include detecting an exceeded time period following a previous negative calibration. The time period m y comprise about twenty-four hours or the like. Triggering the negative calibration ma include detecting an exceeded count limits following a previous calibration check.

The method roay include bypassing the triggering, of the calibration check.

Bypassing may include detecting at least one of the following: detecting at least one previous count following the startup event, detecting less than an exceeded time period follo wing a previous calibration cheek, and detecting less than an exceeded number of counts following^' revious calibration check.

The method typically includes courparing objects on the low calibrator to a predetermined limit. Generating the invalid determination from a number of the detected objects may include ^'su stantially greater than a^■ predetermined limit. Farther, the method may include activating a cancellation of the ea hradon, for nstaace ending a pre- required calibration, upon die nvalid deteonination. Alternatively, the method may include determining a valid result whea a smroher of the detected objects comprise substantially less than a predetermined -limit The method may include activating_, a completion of the negative cSlibr^iio^ for astance a subsequent required positive calibration check. The method may include prompting an -alert to perform a positive calibration. The method may include triggering, for instance automatically, a positive calibration. The method may include prompting use to align a high calibrator in. the plate reader. The method may include comparing objects identi fied though any of me imaging analysis and procedures herein, on the high calibrator to a predetermined limit. The me hod may include determining an invalid result when a number of detected objects comprise outside of the predetermined limit.

ϊη certain examples, the reader may generate calibration, determination alert The method may include generating a no calibration selection. The no calibration selection may he generated by a user identification input. For instance, wherein receiving an. administrator identification., a calibration check may he overridden. Alternatively, receiving a non-administrator identification^ i.e. a non-proper override idendiieation input may generate an override denial, The override denial may cancel the calibration. check, for Instance required calibration cheek, to ctivate subse uent sampl testing shown and described herein,

in one embodiment, positive calibration of a plate reader includes inserting a high calibrator within the plate reader: imaging the high calibrator; counting image counts identified on. the high calibrator and coropasdftgthe image counts to a predetermined posi tive count, wherein counting a quantity of objects a roximate to the predetermined positive count generates a valid etermination and counting a quantity of objects outside the predetermined positive count generates an invalid detennlnation,

o. particular examples, the method includes selecting manually, either on a technician level Or adrninlstrator initial setting level, a calibration activation. The approximate positive. cou t may comprise about t wo percent to about ten percent o f the prede eni iiied positive count for instance the. approximate -posit ve -eonnt- may - c mprise about five percent of the predetemiined positive count,

in certain examples, the method, may Ineinde prompting an alert to accep the 5 calibration coimt Accepting, -the calibration .count may generate a count plate screen.

The ^'method may include promptin an alert to rej ect the calibration count. Rejecting the calibration coun may cancel a calibration routine, in some examples, inserting the high, calibrator includes aligning a high calibrator plate about sunken support frame_* For instance, aligning the high calibrator plate may include positioning a pair of opposing 10 plate proximate apertures hi a pair of corresponding frame proximate apertures, and

positioning distal plate plait >rnl 1» a corresponding distal : -fr me platform aperture.

In another embodiment of the disclosure, i a plate reader for observing biological growth, when present, on a growth plate, a method of calibrating the plate reader comprises selecting a count plate activation; triggering a calibration check; performing a I S negative calibration; and performing a posit ve calibration.

In particular examples, selecting the activation includes selecting a coimt plate button. Triggering the calibration check may include detecting a first count of a startup event, Triggering: the calibration check may include detecting an exceeded time period following a previous calibration check. The time period may include about twenty four 0 hours. Triggering the calibration check may include detecting an exceeded limit of

counts following a previous calibration check.

In some exampl es, the method may include bypassing of triggering the calibration check. Bypassing ma Include detecting at least two events of detecting at least one previous count following the startup event, detecting less than an exceeded time period 5 folio wing a previous calibration check, and. detecting less than an exceeded number of counts Allowing a previous calibration cheek.

In particular examples, the method may include generating an alert to perform the negative calibration. The method may include prompting a user to align a negative calibration plate, in the plate reader. P.erfo mmg the negative calibration may include receiving a negative calibration plate is the plate reader, Tbe method may ude counting objects on the negative calibration plaie. The niethod m y include comparing objects identified on the negative calibration plate to a predetermined limit. The method may include deterrhMng an In valid result when a number of the detected objects comprise substantially greater than the predetemiined limit. ^'The method may include acti vating a ca».c l.¼tioii. of the calibration check.

In some examples, the metbod may include determining a valid result when, number of the detected objects comprise suhstandally less than the predetermined limit. The method may include activating a completion, of the calibration cheek. The method may include prompting a user to perform he positive calibration. The method ma include generating an alert to perform the positive calibration. The method may include prompting a user to align a positive calibration, piate in the plate reader. Performing the positive calibration may include receiving a positive calibration plate in the plate reader. The method ma include counting objects on the positive calibration plate. The method may include comparing objects on the positive calibradort plate to a predetermined limit The method may include determining an invalid result when a number of detected objects comprise substantially g eater than the predetermined limit. The method may include cancelling the calibratio check. The method may include determining a valid result when, a number of detected objects conipnse substantially less than the predetemiined limit,. The method may include completing the calibration cheek or cancelling the calibration check.

In particular examples, the method may include generating a calibration determinatio alert. The method may include generating a no calibration, selection. The no calibration selection may generate a user identification input. Receiving an administrator identification input may generate a calibration cheek override, Receiving a non-administrator identification Input may generate an o erride denial. Further, the override denial may include cancelling the calibration check.

In one embodiment of the: disclosure, a peel plaie for enumeradng a

microorganism^ when present in a sample, comprises a recessed well having a sunken wall pronuding from an upper face; a p r of opposing proximate: extensions adjacent the recessed well; a distal raised platform adjacent the recessed well; -and a foldout label aligned between the proximate extensions and the distal raised platform, wherein the ^•foldout label, having a collapsible notation tab hinged about: a perforated fold.

h particular examples, the foldout label includes a peel tab positioned along a bottom portion of the plate and adapted to removably separate a portion of th e label to expose the recessed, well The foldout label may include a hinge securing the notation tab. The notation tab may overlie the foldout label in a stationary position and hinge in an operation position. The notation tab may include a secondary adhesive. The_. notation tab may include an inner notatio face. T e notation tab may inel de an outer notation face,

in some examples, the fbldout label, has a dimension larger titan a ditnension of the recessed well The foldout label may align adjacent the proximate extension and adjacent to the distal raised platform. The. recessed well m y align below and parallel to an upper face of the plate and may include a grid. The proximate^' extension may be ^•spaced between an access indent and adjacent the foldout label. The distal raised platform, may span .about a length of a diameter of the recessed well The plate may include a col tare medium secured in the recessed, well.

In another- embodiment of the disclosure, an adhesive cover removably enclosing a growth plate having a recessed, well, comprises a foldout label havin a securernenl bottom side an an opposing upper side; an adhesive applied to the bottom side to removably enclose the recessed well; and. a tab pivotally secured along one edge of the upper side and having at least one notation face.

In particular examples, the tab aligns above the upper side in a stationary position and pivots substantially parallel and adjacent to the upper side in art operation position:. The tab may include a secondary adhesi ve adapted to releasabiy secure the tab about the upper side. The tab may include m inner notation face adapted to receive at least one notation. The notation may be a printed -notation, a barcode, an electronic coding, a handwritten notation, and an other notation, data, or descriptive identifier. The iab roay include an outer notation face receive at least one notation. The tab may include a hinge. The binge may include a perforation fold. The foktout label may have a dimension large* than a dimension of the recessed well The growth plate may have at least one proximate extension adjacent the recessed well and a distal raised platform adjacent the recessed -well, and the fohioat label may align between, the oximate extension and. the distal raised platform,.

In another embodiment of th disclosure, an assembly comprises a growth plate having a recessed well to receive a sample, a raised platform, and a proximate extension; dried media culture posihonable within the recessed well; and a foldout label having a notation tab hingedl secured to the label and having an inner notation face and an outer notation face, and wherein the notation tab overlies the label i a stationary position and hinges to an. operation position.

In some examples, the notatio tab includes a perforation fold. The notation tab may align, parallel to the foldont label's upper side in a stationary position, and pivots substantially one hundred and eighty degrees about the perforation, ibid in the operation position.. The notation tab ma include a secondary adhesive reieasabl securing the notation tab about the foldont label in at least one stationary position. The notation tab may include an inner notation face ha ving a substantially flat surface to receive at l ast one first notation, for instance a printed notation, a barcode, an electronic coding, a handwritten notation, or the like. The notation tab may include an outer notation face having a substantially flat surface to receive a notation. The second notation may be independent of a first notation.

In some examples, the foldont label bas a dimension larger than a dimension, of the recessed well The tbidout label may align between the proximate extension and the distal raised platform. The foldont label may include a peel tab positionable along a. bottom portion, of the plate and removably separatin g a portion oftbe label, to expose the recessed well. The recessed well may align below and parallel io an ppper face of th plate and. m include a g id, Further, the proximate extensions may be spaced between an access indent and adjacent the fbldowt label The above siMft iar was Mended to mrnnrize certain em odim n s of the present disclosure. Embodiment will be set forth -is more detail i» the figures and description of embodiments below, it mil be apparent, however,, that the description of embodiments is not intended to limit the present inventions, the scope of which should be properly determined by the appended claims.

B rief Description of tfee Drawings

Embodiments of the disclosure will be better understoo by a reading of e Description of Embodiraorrte along with a review of the drawings, in which:

Figure 1 is a front view of one embodiment of a plate reader according to the present disclosure;

Figure I. A is a front view of one example of loading a plate into the plate reader introduced in Figure 1;

Figure 2 is a front view of the plate reader introduced in Figure 1 in a loaded, operating position;

Figure 3 is a schematic view of a plate reader assembly according to another embodiment of the disclosure:

Figure 4 is a perspective view pi a plate reader assembly according to one embodiment of the disclos re;

Figure 5 is a screen view of one embodiment of a plate type selection:

Figure 5 A. is a scree shot of a user interface embodiment according to the disclosure:

Figure 6 is an. exploded perspective view of particul ar system elements;

Figure ? i an exploded perspective vie of the system shown in Figure 1 with elements removed for clarity

Figure 8 is an isolated., top view of & inountlng foundatio shown m Figure ?:.

Figure 9 is an. isolated,, top perspective view of a base plate shown in Figure 7;

Figure 10 is an isolated, top perspective view of an embodiment of a frame nest and corresponding plate;

Figure 1 1 is a top perspective view of one embodiment of a peel, plate wife a singular , planar peel;

Figure 12 is a top perspective view of one -embodiment a peel plate according to the disclosure:

Figure 13 is a bottom perspective view of the peel plate introduced in Figure 12; Figure 14A is a side perspective view of the peel plate introduced m Figaro 12; Figure 14B is, a to view of a peel plate embodiment mmg a fdldoat label cover;

Figure 1 C a top perspective vie of the example introduced in Figure Ί.4Β, with. Che peel plate separated irom the label eov^r to illustrate eleftiente;

F ure 14D is a to perspective vie of the example introduced in Figure 14B, with elements of the fbldou la extended in one embodiment of an operation position;

Figure 15 is aft overview flow chart of an operation sequence;

Figure 16 is a schematic flow chart of one embodimeot of a calibration sequence;

Figure 17 i a schematic flow chart of one embodiment of qualit control events triggering a calibration process;

Figure 18 A is a schematl e flow chart of one example of a negative calibration sequence;

Figure Γ8 is a screen, view of one example of a negative calibrati a prompt; Figure 18€ is a screen view of one example of a negative calibration result display;

Figure 10A is a schematic flow chart of one example of a positive calibration, sequence;

Figure I 9B is a screen view of one example of a ositive calibratlori residi display;

Figure 20 is a schematic flow chart of another example of apositive calibration. sequence;

Figure 21 is a schematic flow chart of ooe example of a calibration override process;

Figure 22 is a schematic flow chart of one embodiment of a calibration sequence; Figure 23 is a screen view of one embodiment of a visual check display; and Figure 24 i a screen view of another embodiment of a visual check display. *

i the tawing description, like reference character designate like or

corresponding parts throughoir the several views. Also in. fee following- description, it is to be understood thai such terms as "forward," "reatwaixl," "lef ," "right "upwardly, " ^i!d.ow war ily_s" and th like are wo ds of convenience and are not to be construed as limiting terrus.

Referring no to the drawings in general, it will, be ondmteod that the

illustrations are for the purpose of describing embodimen s of the diselosnre and are not Intended to limit the disclosure or any invention thereto. As best seen in the yarions figures, plate reader systems and assemblies are shown embodied, according to th present disclosure for biological growth counting with proper plate seating and activation,_: increased sample throughput, direct data results reporting, and processed plate image - storage. The reader system ID generally images biological development, when present, on as nidividual growth plate 20 and/or a plurality of growth plates 20, or similar testin medium. The methods and operatio generall include calibration sequences and. quality control processes prior to and/or during imaging/counting procedures on any o f the plates shown and described herein,.

Figures 1-2 and 6 illustrate embodiments of a plate reader to generally eai!brate tbe unit before testing, and the receive, image, and count microbial colony growth,, when present. These assemblies include plate imaging, processing, and user interface elements, ei her in electrical commnnicaiion with one another or combined into an integral assembly, as understood by those of ordinary skill in the art having tbe benefit of this disclosure.

In certain embodiments, housing features and a variety of outer supports alig and. shield internal components. For instance;, as shown in Figure 1, an ente housing 240 surrounds internal Imaging and processing components to generally define an. integral system. The housing 240 may include a plurality of openings to allow access to the plate nest frame and like elements shown a described herein. As shown in Figure 6, useful, although not necessarily required in ever embodiment, elements boused within honsing 240 ma ^■ include a moot g foundat on 58, a backlight dil nser 68,. a base plate 64, a portion of a nest frame 66, an. flluismation. dome 84, and an optics imaging device 12. As shown in Figures 4 and ίί, the illumination dome 84 may include an optics enclosure 1 8 to generally enclose the imaging device 12. The filnmmation dome 84 ma evenly 5 illuminate the plates and prevent reflections on the plate surface.

Figure 3 illustrates one example of a no» megraI reader assembly having a plate imaging unit and reader system in data enmnrmueation with a comp ter processor 150. The assembly typically includes a» image processing engine to perform eolony counting: to connt and or rnoriitor ialogical growth, including microbial colony counting, bacterial0 counting, and the like, hen present on the growth plate. In particular examples, the c mpnter processor 150 is a qualified laptop, tablet, or the like miming plate analyzer processing described and shown herei ,

As shown, in Figure 1, 3_:! aori 4, the reader system may roclude an. iroaging device 12 adjacent to the plate 20 i a imaging position. An alignment braeket(s), frame, and 5 the like may secure any of elements shown and described her era in a semi-fixed posi ion.

For instance, a lower fitting 214 may be affixed to the illumination system, housing, or the like. Similarly, an upper fitting 213 ma be affixed, to the imaging unit, devices, bousing, or the like. The lower fitting 212 and upper fitting 21 may fee secured about one another in a variety of configurations and alignments, including, but not limited to,,(1 with a fastener 14 or similar, linkage. The lower fitting 212 and upper fitting 21 may be positioned together with at least one adjustment lb certain examples, the -adjustment includes an off-axis, ie, a horizontal, vertical_., or the similar, adjustment.

The system may incl ude sensors 154 to indicate any of the alignment and/or alert system errors shown, and described herein. Further, the system, may Include i!Jonnnarion5- ^'control 156 to control any of the illnnihiation elements and aspects herein. 1B addition, the system may include power distribution 158 to control and distribute power for any of the elements and aspects shown and described herein, and a power supply 162, including but net limited to an external power supply. Certain, reader syste elements are in electrical eonnuumcaiioB with a user interface,, for instance computer processor 150, vi a unified, communication interlace 160 and/or USB connection 152, Ϊ5 or fee like.

Those skilled in the art having the benefit of this disclosure will recognise additional orientation of .coxnpoueitis in ^'electrical communication, including alternative integral and non-integral. arrangements of imaging, processing, and display elements herein,

Figure 10 shows one example of a parti ally ex loded nest frame for illustrating internal alignment components withi the assembly as generally shown, and described, herein. As previously sho wn In Figure 1 A and 2, a user may manually load the plate into the nest frarne (including aligning my of the growth plate features with, any of the frame support features shown and described herein) into a focal alignment with art imaging device in the reader system.,

In use, embodiments of the systems and processes ma be triggered in a variety of ways, including, bid not limited, to, manual selection on a use interlace, voice activation, remote or timed start, manual positioning of the plate, and the like. In parlieular examples, the operator manually selects the proper plate a d/or count operation to be performed by the assembly, tor instance fr m aay variety of selections on a nser interface or the like. As illustrated in Figures 3, 18B, 1 SC_f embodiments of fee user interface selection, screen 1.50' may include a count plate selection 185, a review counts selection 194, a plate preview selection 1 5_f and a calibration cheek selection 300, to select and activate any of the systems and processes shown and described herein. Typically fee nser interface selection screen 150' includes plate type input 190, for instance chosen rforn a drop-down seieedon, button, voice command, manual input and the like. The selection may include at least a first plate type identifier 180 and a second plate type identifier 182, In other examples;, the selection screen 1.50' includes apl uraliiy of plate type selection identifiers, including four or more identifiers. The operator may manually select the plate type selection, for instance via clicking, touching, speaking, or the like, the proper icon, voice activating fee assembly to types of plates to oonni, or similar selection processes, The nser Interface m y include a first plate count inpnt selection 184 and a second, plate count . input selection i 86, Again, other example of the selection screen: 150^* includes a plurality of other manual plate type count input selections. in particular examples,, the first pl te type Identifier 180 includes_, an aerobic count used for the detection and munieiation of aerobic baeteia in dairy and food deefenai dilutions. The aerobic count ma include fighting settings, imaging settings, and similar counting setting as rec gnised by those skilled in the art having the benefit of this disclosure. The second plate type identifier 182 m y include n E-coli and coliferni count used f&r detection ¾ad enumeration of eolif rm bacteria, including E-coli In dairy, food, and water. Again, the E-coli and co or const may include lighting; settings,- imaging settings, and similar -counting settings. Another plate type identifier may nclude ;a yeast and mold count for detection and enumeration of yeasts and/or molds in foods and environment. In. addition, another p! ate type Identifier may include a heter ©trophic plate count used. ^'for detection, and- enumeration of water samples,

in certain examples, a user selects a plate type (including any of the plate type selections shown and described, herein). The user may load a blank plate for quality control assurance, and or_. calibration as described herein. The device may then capture au. image of the blank plate, in particular embodiments, the user interface selection screen 150' may have a plate preview selection, for instance an image of the plate without performing a count for visual preview and review as understood by those skilled in the art having the benefit of this disclosur .

In certain examples, the image is stored on a storage device, processor, cloud storage hard drive, or the similar rneans. in particular embodiments, whe a memory, or the like, is approaching eighty five percent, or similar percentage greater than or less than eighty-five percent, capacit a message may he generated to prompt the user to achieve the data. In certain examples, the archival of the data Is a manual operation.

In addition, any of the data herein may be secured, by limiting access to the folder where the data is saved, for instance at the. Windows level, to allow an administrator eusnrc the folders are invisible and/or not deieteable. In these examples, an end User may disallow a particular user from accessing data at a particular location as understood by tho se skilled in the art having the benefit of this disclosure. In certain examples; » a user maaaally loads the plate with the sample and selects the count plate indicator to initiate a particular sequence, for instance fee plate is typically manually loaded and the indicator is selected prior to imaging the plate. The imaging device may capture one, or multiple frames averaged together for greater consistency, to § create m image using pixel-to-pixel averages for noise reduction of frames. In some examples, the device may set a plate identification, for instance by reading ^'barcode or the like. The s stem may verify a plate diameter to ensure a proper plate is being analyzed, in particular examples, the system, checks .the diameter of the plate to verify a proper plate is seated in the system, including., out not limi ed to, monitoring if the plate is

10 properly seated and an edge is visible to trigger an out of position message, for instanc to reject analysis of a particular pkte(s).

in particular examples when the second plate type identifier 182 ibr an B-coli and co!iform count is selected, the system loads average and background images. The system may then crop an average image to yield an image of active portions of the pate as

15 recognized, by those skilled hi the art having the benefit of this disclosure. The system may then crop background image, divide the average image by the background image to yield background-subtracted image. The system may then invert the .image and threshold, the image in any of the methods shown and described herein, to identify primary objects, including colonies. The image may then be cropped again and the color objects may ^'be

■20. unmixed. For instance in the E-eoii and. eoliforro count, the systern separates (unmixes and the like) and counts the red color counts and the blue color counts. In particular examples, the results are recorded and saved to a database by an of the procedures described herein.

Similarly, when a first plate type identifier 180 for an aerobic count used for the 25 detection and e umeration of aerobic bacteri is selected, the system loads average and background images. The system may then cro an average, image to yield an image of active portions of the pate as recognized b those skilled in the art having the benefit of this disclosure. The system may then, crop background image, divide the average image by the background image to yield backgrouad-subtracted image. The system may then. mask colors_, of the im gery typically the mask may be defined in the graphical user interface The color objects may be u mixed, The system then thresholds the image a any of the methods shown and described herein to identif primar o jects, including colonies, in particular examples, the results are recorded and saved to a database by any of the: procedures described herein. Those skilled the art will recogni2e additional operations and methods, including any image counting method, triggered ^"by a selected plate type selection 1.90 with the benefit of this disclosure.

In certain embodhneniSj airy of the background and associated values, counts, etc. herein may include a password protection, tor instance at an administrator level. For exanipfe, any of the ¾et background'* steps or processes may include a login prompt, wherein an administrato level entry allows abackground to be specified, and an operator level entry is denied setting a particular background process.

In particular examples, the user ^'interface display 130" presents a count result 194. Figure 23 illustrates one example of a visual, check 250, wherein the user interface shows a dilution factor 258, notes entry 25 , a count result 254 and/or image with counts 192, a spreader count result 256, and the like. Typically, a visual check window maybe closed and re-accessed b a manual edit selection,, for instance with may be generated under the plate review selection as shown and described herein, A. mouse or figure selection may enlarge the image to better vie detected and counted colonies. In some examples, each counted colony may have a line encircling the results, that may be viewed ^•via. enlarging the image. In particula examples, an aerobic count may have a black line, while eobfbrrn. and the like may generate a colored, fo instance red or blue, line depending on the reader settings. A described herein, the counts may be ..manually edited, for instance in the save result window in the user interface, to determine if there are colony oonni omissions, additions, amendments, or the like. Further, result notes 252 may be added to any of the resul ts/display herein. Figure 25 illustrates another example of a. visual check 250 with a generated resul t of a too numerous to count (T TC) 260 result. In particular examples, the visual check may be generated and suggest a number of colonies md spreaders or TNTC mtorpretaticm ^'fci particular examples, these results may be manually edited and or stored as shown and descr bed herein.

One embodiment of the plate type selecti on includes manual entry, for instance a ^■forced sample entry 400 as illustrated in Figure 5, As shown is Figure S_t sample entry 400 on the user .interface may include plate type selection 402 and a sample identification entry 404, or -the like. The -user interface display result ma Include marking bacterial colonies in. variety of displays, configurations,, arrangements, anil the like. For Instance,, as illustrated in Figure- 5A, the displa ISO^'** may present, circled bacterial colony counts 192 ou an image of the plate,, or the like. The processed image 150" may include a coded name, for instance marked ou a barcode or the like as described herein, and a CSV file wife corresponding colony count information. The output image and an. outpu report will vary depending on the type of plate being processed. For example, an aerobic count may indicate a unified count of all colonies, whereas an E~eoIi count contain color categorized colonies.

Figure illustrates useful internal elements, for instance base plate 64 and

^■mounting foundation 58 assembly. The mountin foundation may include one or plurality of supports 138, including suction cups, fittings, braees, and the like, to support any of the plate imaging units shown and described herein about a fiat surface or similar laboratory bench. Fasteners 139, 1 6, and 148, a well as gromrnet 152 and spring plunger 154 m ay secure the base plate 64 abou the mounting foundation SB and/or other bodies. Further, a backlight dif&ser, for instance the backlight box 68 may be positioned between the base plate 64 and moiau ng foundation 58 to generally diffuse flat lighting under the plate to enhance silhouette detection.

Figure 7 shows o»e example of mounting foundation 58 of fee image station for supporting the plate imaging unit. The mounting fbundati on 58 may include one or more mourning holes 136 to mate with, the base plate 64. Further, the mounting foundation 58 may include a foundation framing 130, or similar solid supporting, to support the load of any of the elements and examples sho wn and described bcrein. The mounting foundation .5.8 may include base plate couplers 132 and backlight feffnser couplers 134 so support and p ovide etearao.ee for foundation and lighting elements. Those of ordinary skill in the ait having the benefi of iMs disclosure will recogn z additional^■■ framing and support elements and alternatives.

Figure 6 illustrates one .example of a baseplate 64 to generally align plate frame nests. For instance, any of the reader ev ces herein may include^' a frame nest support to generally receive and retain any of the plates dnring operation and the like. As shown in Figure 10, receiving nest; .may include a^■ sunken support frame 42a surrounded by a raised boundary 46a, thereby providing a cavity to receive and retain the plates, i particular examples, the support frame 42a may include a recessed distal platform aperture 182 , a recessed well aperture 1 SO, and a pair of opposin proximate apertures 184 to mate with a corresponding inverted growth plate's recessed well, pair of opposing proximate extensions, and distal raised platform as shown and described herein. An attachment portion 166 may align the frame nest about any internal structure, for instance within the housing. Farther, an optics- aperture 1.46^' may be aligned i the alignment cradle 140. In. one example, a backlight indent 150 mates with the backlight 6S centered on the optics -aperture 46.

Any of the reader devices herein may include a frame nest support to generally receive and retain any of the ^'plates during operation and the like. As shown in Figure 10. a receiving nest ma include a sunken support frame 42a surrounded by a raised boundary 46a. thereby providing a cavity to receive and retain the plates. In particular examples, the support frame 42a may include a recessed distal platform aperture 182, a recessed well aperture I SO, and a pair of opposing proximate apertures 184 to mate with a correspond ng inverted growth plate's recessed well pair of opposing proximate extensions, and distal raised platform as shown and described, herein. An attachment_. portion 166 may align: the frame nest about imaging elements,, for; instance 'within the housing.

Those of ordinary skill in the art having the benefi t of tins disclosure will reepgnize thai any of the growth plates shown and described herein may include plate- like devices, Petri, dish culture devices, and the like. Typically, the growth plate 20 includes a growth area where biological growth., or the like, may develop. As shown m Figures 12-1 D_? me growth ¾ n be transparent and niay have a recessed well that is useful for enl tilting: various microorganisms.

Figure 11. introduces one example of a peel, plate 110 haying a covered surface as sh n sad described herein. For instance, the pee! plate 110 may be placed on a substantially level surface. The peel tab 52 may he lifted concurrently while pressure is applied to the raised platform 28 with the user's Sogers, or the like, in particular examples, the tab 52 may he lifted vertically upwards and away to expose any of the culture media shown and incorporated herein. 1B. particular the culture media is any of the dried media culture disc shows and deserihed herern.

Figure 1 introduces one example of a culture device peel plate 110 for enumer ti g and/or detecting a microorganism from a sample that is useful for the reader examples and ernbodir ents shown and described herein. The peel plate 110 typically is a semi-rigid waterproof pl te onto which sample may be applied to enumerate

mi eroorgaru sm and the like,. As seen in Figure 1 ¾ one example of the peel plate 110 includes a recessed well 12, a distal raised platform 28, and opposing proximate tabs 22 ba:vmg Oxiuiate exteusions 28 to support stacked plates as shown and described herein. The upper face 14 of me pl ate typically has a top periphery 32 around the raised platform. The recessed well 12 includes a sunke wall 24 below the upper face 14. As shown m Figure 12, the recessed well may include a grid, for instance having vertical line 40 an intersecting horizontal hue 42 components -useful for colony coording. In particular examples, the grid Is molded, printed, and the like on the rear su face. The grid may be prin ted in variety of ways, including Inkj et priming, pad printing and t e like,

Regardless of the grid type, the grid is typically visible through the generally transparent culture device to the front surface and/or rear surface. The plate 110 is also typicall transparent material so as to enable observation frorn the outside, including- any of the printed grids shown and described herein.

Figure 12 .further shows the proximate end of the peel plate i iO include an access indent 20 with opposin proximate tabs 22 between rounded, comers 18, Typically, the proximate tabs 22 offset the proximate e t nsions, and the like, from t e body of the plate, i.e. the we l and the majority of the upper surface. Thereby the proximate tabs include proximate extensions 18 for alignment, stability, and support during testing/usage, including, but not limited to, layering and stacking plates in an of the arrangements and orientations shown and described.

Figure 13 shows a bottom mid side view , respecti vely, of one example of a peel plate I.J 0 having a raised edge 30 extending above the lower fece 16 to define the raised pMtfhr 28. Typically, the pee! plate has a. distal thickness 42 to snpport any of the elements and testing procedures shown and described herein.

Figure 1.4B illustrates one example of the culture device peel plate having a ieidout label cover 11 secured about upper portions 1 \ 14". As shown, the foldmu label cover 11 is positioned over the recessed well 12 to provide any of the feature shown, and described herein.. Other examples include alternative positioning of the recessed well 12, for instance a reverse alignment, scaled down or scaled up

embodiments, offset alignment, and the like. Additional examples may include multiple label covers. Typically, the foMout label 11 aligns between the distal raised platform 28 and at least one proximate extension 18, including_, adjacent to the distal raised platform 28 a d at least one proximate extension 18, However, alternative examples include aligning the foMout label 11 on a peel plate without a: distal raised platform. 28 and/o a proximate extension 18. The label cover 1 1 may include a hinge 15 supporting a notation tab 13. Those of ordinary skill in the art having the benefit of this disclosure will recognize many notations suitable for the present inventions. For Instance, any of the notations herein may he a printed notation, a barcode, an electronic coding, a handwritten notation, and any other notation, data, or descripti ve Identifier. Applicant has unexpectedl discovered a larger footprint surface area without sacrificin the compact and storage features of the plates shown and described herein, for instance to support large labels, barcodes, and the like.

in some examples, the ibldout label cover 11 may have a perforated fold 25 to allow the notation tab 13 to align above the plate in a stationary position and pivot for liga on in any type of operation position, (as shows in one example in Figure 14D), As iilestratsd in Pigpre 14C_} the fhldmit label cover 11 may include a see arement bottom side 23 aad an opposing upper side 21 , As show and described herein, tbe seenrernent bottom side 23 may be adhered to the plate surface.14 by any means, including, but not limited to, adhesives, mechanical bonding, fasteners,, and rise like, in par dcular examples, as shown in Figure 14B, portions of the se urement bottom side may be permanently affixed to the plate adjacent plate surface 14 ^* while portions; of the seonremeni bottom side may he removably affixed to the plate adjacent plate sitriaee 14" to provide access io the recessed well as shown and described herein,

Notation tab 13 may be pivotaliy secured al ong one edge of the upper side of the foldout label cover 11. and has at least one notation face; The notation tab 13 may he aligned on either edge of label cover 11, for instance to improve right-banded or left- handed user orientation. Fa ther^ multiple notation tabs 13 may he aligned on either or both edges of fbldont label, cover 11 to provide any testing or laboratory best practice as recognized by those shitled in the art having the benefit of this .disclosure.

As shown in Figure 14D₅. the notation tab 13 may have an inner notation face 2? to receive at least one notation. The notation tab 13 may pivot, fold, or otherwise traverse substantially one«hundred~and~eighiy degrees, or any other degree of rotation greater or less than one-hundred-and-eighiy degrees for a desired positioning, about perforation fold 23 to create an: operati n position. The inner notation face 27 may also include a secondary adhesive to reieasably secure the notation tab 13 about, the upper side 21 of the label cove 11 in a stationary position. The secondary adhesive reieasably secures the notation tab 13 in a stationary position prior to nse, as well as may reieasably secure the notation tab 13 in the stationary position, after a first use and/of subsequent inanipnlations. Similarly, the opposing side of the notation tab 13 incindes an onter notation face 29 to receive at least one_: of the notations shown and. described heroin.

As shown in Figures 1.5, 18B, 18C, and generally described herein, the plate readers, devices, and assemblies may include calibration sequences and quality control processes to improve accurate, reliable test resnlts. Figure 16 illustrates on example of a caltetioii sequence 300 that begins with a count plate activation, i.e. any of the acti vation 1.90 steps shown and described herein. A calibration sequence 300 nia be triggered 306 from a variety of events, and may include a negative calibration 302 asd or a positive calibration 04.

Figure 17 introduces several events thai may trigger 306 a calibration process, while those skilled m the art having the benefit of this disclosure wil recognize additional events and procedures steps to trigger calibration or a quality control process, la particular exam les, a first count since startup 312 may trigger a calibration process. Thus, detecting a first count of a startup event may trigger the calibration or quality control process, Further, in some examples, a time period since the last calibration check 31 may trigger a calibration process. Thus, detecting an exceeded time period following a _.previous calibration cheek may trigger the calibration or quality control process. For instance, the time period may be twenty-four hours, while other examples include greater and less than twenty-four hours. Additionally, in. some, ex m les, a number -of counts generated by any of the devices and. assemblies herein since a last calibration check over a specified limit 316 may trigger a calibration process.. Thus, detecting an exceeded limit of cornits following a. previous calibration check may trigger the calibration or quality control process. As also shown in Figure 17, in certain examples if no event or situation triggers a calibration process 3 0, the reader/assembly may count objects In the plate according to any of the examples and embodiments herein.

Certain calibration or quality control processes include a negative calibration, for instance as raised by a "calibration check required now" message, or the like. Procedure steps and pOcesses of one example of a negative calibration 302 sequence is shown in Figure 1 SA-i SC. A user may activate the system by any of the manual and similar activation steps shown and described; however, alterative examples clude automatic activation to initiate any of the calibration sequences or quality control process as recognized by those skilled in the_. art having the benefi t of this disclosure,. Que example is shown in Figure 1813, wherein the reader generates a negative calibration prompt 302 to enter a low calibrator, i.e. any of the calibrators shown ari described herein. As shown in Figure 18, tfee.»egati^'ve;.cai¾rafe» .x»ay-$t8tUvitfa; a user ctivation 190, for instance selecting a count plate selection. The plate reader may receive a negative calibration plate,, while other examples include «tili¾i»g a calibrate &af Is a non-plate desigm for inst nce without particular plate dements shown and describes! herein. Irs particular exam les, the system may generate an alert to perform the negative calibration 302. For instance, the process may include prompting a user to align a negative calibration, plate in me plate reader, itrekidmg aligned within the reader nest f ame, for a negative calibration plate to ^"be counted 320. The system, may count objects 320 on the negative calibration plate and compare the tmrriher, size, dimension, color, etc. of the. objects to a predetermined limit to determine if the count is greater than: the limit 322. hi some examples, the determination may generate an INVALID result 324 and a subsequent calibration, cancellation, for instance in. particula examples, ultimately o!osing .the required edibration for activating any of the sample testing procedures. Alternatively; the determination may generate a valid result 326 and ma proceed to a

Figure.18C. illustrates one example of negative calibration sequence results 304 display, wherein .the;^' VALID result 310. maximum predetermined limit 312, and actual count 314 are generated and displayed on the user interface,

Figures 19A, I9B₅ and 20 introduce embodiments of a positive calibration 304 sequence, A user may activate the system by any of the manual and similar activation steps shown and described; again, however, alterative examples include automatic activation to initiate any of the calibration sequences or quality control process as recognized by those skilled In the art having the benefit of this disclosure. The positive calibration may start with a. user activation 190, for instance selecting a count plate selection.. The plate reader may receive a positive calibration plate, while other examples xachide utilizing a calibrator that is a nonmlate design, for instance without particular plate elements shown, and described herein.

la particular examples, the system may generate an. alert to perform the positive calibration 3 4. For Instance, the process ma include prompting a user to alig positive calibration plate fa the plate reader, Including aligned, within the reader .Bes frame, for a positive calibration plate to be counted 320, The system, may eo¾ t objects 320 oa the positive calibration plate and compare the number, ske, dirnension, color, etc, of the objects to a predetemiinel limit to determine if the count is greater than the limit 330.

m some examples, the determination may .generate an INVALID remit 324 and a calibration cancellation, for Instance in particular examples, ultimately closing the required calibration, for act vating an of the sample testing procedures. Figure I9B illustrates one example of a positive calibration, results 306 di splay, wherein the VALID result, maxhttum predetenrmied expected count 320, actual count 124 are generated, and In certain, embodiments, displayed on the user interface. Further, a selection to accept the calibration result 32 may be generated from the sequence and presented on the calibration display 300, Alternatively, the determination may generate a valid result 328 and/or prompt as alert for a calibration complete indication 310, However, as shown in Figure 20, a valid result 328 may trigger a NO selection acceptance 332 of the result or a YES selection acceptance 334 of the result, For instance, the system may prompt a user to indicate a NO selection 332 or a YES selection 334 regarding the valid result.

In certain examples, the NO selection cancels the calibration sequence 324.

Whi e, a YES selection may complete the calibration sequence 10. In particular examples, complete cal ibrailon 310 may set a timer fo continued, including sernh continuous, usage without requiring a calibration sequence. For instance, a complete calibration 310 may trigger a twenty-four hour calibration complete tinier, while other examples include less than and greater than wenty-four hour periods.

Any of the calibratio sequences and quality eontrols_: herein may be overridden ior a variety of reasons as recognized by those skilled in the art having the benefit of this disclosure. For Instance, the system may generate a calibration check: required, CHE JK NOW? alert, or similar message OS, The system ma generate a select YES indication 340 to trigger any of the calibration processes 30() herein.. However, the system may also generate a select NO .indication 342 and accept user indemrufication input 344, Far instance, a user may be prompted, to enter a usernarne, password, and the like. The system may review the user indemnification to determine m admimst tor entry 346 or similar properly I ogged-in user to override any of the calihrati on .sequences and quality controls. In certain examples, whe the system receives a valid or proper administrator iden&fieatian input, a .calibration cheek override 348 may be generated to eanee! calibration. Alternatively, when the system receives an invalid or improper administrator identification ut an override denial 350 may he generated and thus requiring any of the^■calibration and or quality control processes before generating an of the test results sho wn and described herein.

Figure 22 illustrates additional elements and exampl es of calibration sequences and qualit control processes io improve accurate, reliable test results.

The processors described herein are typically in electrical communication, including USB connection, wirel ss* or the like, with the plate imaging unit. The processor may include an image processing, engine to perioral colony counting operations and die like. To articular examples, the image processing engine has image inputs and pipeline parameter inputs. Particular parameter inputs are determined by calibration, including- an of the calibration steps and examples herein. Othe f xed plate type parameters may he feed. The image processing engine m ay ge erate a vari ety of outputs, tor instance colon eonndng inforniatiou.

Farther, in alternative embodiments an imaging device may be aligned above the iiluBunatiau system substantially surro nidhig the growth plate. The optics may be an of the imaging devices shown and described herein, including a camera to capture any of the still and video image supported by optics communication,

in. some examples, the camera includes a moveable lens to manipulate the focal distance of the imaging device to capture a variety of pixel mappings. For instance, the camera lens may be moved closer to the plate or more distant, from the plate to gather a variet of pixel mappings, depending, on the particul ar testing sequence.

In some examples, the illiimmatiou system includes a plurality of light emitting diodes (LEDs), Tor instance ninety sk, or the like, white LEDs. The light box may iftd sde ^a perimeter lighting franie having a first second,, third a«d fourth, light sides t provide fo used light on. the top and si des of the peel plate. Farther, t ie light box may .include a dlf!user.

In yet another alterative example, m imaging device is positioned on the mounting arm about^' the u per face of the housing. Those o f ordinary skill in the art Having the benefit of this disclosure will recognize the imaging_, device may include any opli.es electronics processing board. Further, the reader may include a processor to provide any of the imaging and an alysis shown and descri ed herein.

The vision system for any of the imaging devices shown and descried herein may utilize a grid, reference lines, markings, quadrants, and the like for consistent mapping of specified locations on and mon the plates. Further, any of the imaging devices may gather pixel mapping data or values from the entire growth plate or any of me subsections shown and described herein,

h yet other embodiments, several im ging devices may foe: positioned throughout the reader for generating any of the images show and described herein at a variety of angles with respect to the growth plates.. For instance, in some examples fee reader may include at least a. op and a bottom imaging device, while in other examples the reader may include one mobile imaging device that is capable of moving around, or within, the reader to capture images/scaus from the top and bottom perspectives of rite rowt plates. n u e, the: plate imaging ¾nit ma be a dynamic tool for monitoring biological agents and development on growth plates, or similar mediums.. Generally, the reader system includes imaging technology fo observing and quantifying biological grnwtk when present, In this way. Applicants have naexpeetedly discovered the systems shown and described herein enhance the abili y to observe changes in the plate development earlier than provided, for in conventional systems. Further, the systems and methods herein predict a final result before the final result is actually visible by the human eye. For instance, the: systems and methods herein are more sensiti ve than the human eye and conventional assemblies. In. -addition, the systems and methods herei monitor the growth plate to find variability prior to test development. For instance, the systems and methods herein establish a more accurate baseline forraeasnrmg_. changes the growth, plate than provided for in the c¾ny¾itio»aI.-assOT.blies>

h use, the preliminary image may he first captured with any of the Imaging devices shown arid described herein -under an install .calibration, n one example, the settings that configure any optical system, for ideal image capture ma be predefined dw ig-tbe ns k^rx-caiilHstioa phase of system installation- For instan ce, opbniteaiion of lighting intensity, camer o ens a id camera exposnre time may be defined, at an installation calibration set-u . Periodic recallbra ion roay he requited due to any of the •processing events herein, system .aging, and/or meirologieal conditions. In certain exa aples, calibration is achieved wi th pre-priftted sample plates, while other examples include non-plate type calibrators having any of the calibration elements shown and described herein.

In one example, mechanical ali unent of the g owth plate 20 i achieved by drawi g a digital circle around the sam le area, for instance around a calibration object and/or a microbial colony on a sample testing plate. This digital circle may he manipulated via keyboard; keystrokes to align the circumference and diameter with the sample plate area of interest Typically, lighting intensity; exposure time, camera focus and nieeaanieal alignment are configuration settings thai remain, constant after installation, until for; instance re-calibration is desired, or required.

Further, the image area may be reduced to include onl the area of in terest that is predefined by the install calibration, subsequent setting, or a by are-calibration event. Applicants have laiex.peetautf y discovered this reduces processing time, in particular by not having to parse through uninteresting elements, i.e. non-calibration and/or non~ microbial colony growth, as understood b those skilled in the art having the benefit of this disclosure.

Numerous characteristics aid advantages have been set forth in the foregoing description, together .with details of structure and function. Many of the novel features are pointed out in the appended claims, The disclosure, however, is illustrative only, and changes may be made In detail, especially in matters of shape, size, and arrangement of parts, within the principle of the- disclosure, to the fell extent isdicated by the broad general nre&nh g of the iernis in which the general claims are expressed. It Is feriher noted that, as used in this application, the singular forms "a₅" "an," and "¾e" include _.floral referents nnless expressly and wsequivocally limited to one referent.

Claims

What is claimed is;

1. A method of calibratin a plate reader comprising:

a. detecting at least one -event comprising;

i . detecting a first coun of a startup event,

ii . detecting exceeded time period, following a previous calibration check, and

iii detecting an exceeded count limit following a previous calibration check;

b. receiving a negative calibration plate, counting objects identified on said negative calibration plate-, d comparing objects o said, negative calibration plate to a predetermined limit; and

c. receiving a positive calibration plate, counting objects identified on said positive calibration plate, and comparing- objects on said positive:

calibration plate to a e eterm ned positive count,

2. The method of Claim L where n, aligning a calibration plate i ne! odes -portioning a pair of opposing plate proximate apertures in a pair of corresponding proximate reader frame apertures, and positioning a distal plate platform in a corresponding distal reader frame platform aperture.

3. The method of Claim I, including generating an invalid calibration result when, a number of detected objects on said negative calibration, plate comprise substantially greater tha said predetermined limit,

The method of Claim 3, wherein counting less than about, four image counts on said negative calibration plate generates valid determination and counting greater than about four image counts generates an invalid detemiination.

5< The method of Claim 4, wher ein generating said valid determination, includes prompting an. alert to perform a positive calibration.

6. The method of Claim 3, further including activating a cancellation of sa d:

calibration -upon said invalid delernnnation.

7. The method of Claim 1 , wherein counting approximate to said pred etermin ed positive eoiffit ener tes a. valid detennmation and counting outside said predetermined positive .count generates an invalid determination.

8. Hie method of Claim .7, wherein, said app.roxirn.ate positive count, com rises about two percent to about tea percent of said predetermined positive count.

9. The method of Claim 1 , including generating a calibration determination alert.

I.0. The me hod of Claim. I, including generating a no calibration adniiiy&trator user identification inpni.

I I. A ^'method of cal ibrating a plate reader comprising;

a. conn ing objects on a first calibrator and comparing objects identified on said &st calibrator to a predetermined limit;

b. counting objects on said second calibrator and. comparing objects

identified o said second calibrator to a predetermined count and e. imaging sample plate and connting bacterial- colonies, when present, on said sample plate after objects idendfied on said first calibrator generate a valid d.efe rninaiion and after objects identified on said second calibrator generat a valid determination.

12, The nieibod of Claim 11, including aligning sai d first calibrator about a sunken, support iranie.

13, The method of Claim Π, including atigmrtg said second calibrator abon a sunken support frame.

14, The method of laim 12 or Claim 13 , wherein aligning said calibrator includes positioning a pair of opposing plate proximate apertures ia a pair of corresponding proxirnate frame apertares, ami positioning a dtstel piste plar&rm 1» a

corresponding distal frame platio.rni aperture,

15, A pee! plate for enumerating a microorganism, when present, in. a sample, said peel plate comprising:

a, a recessed well having a sunken wall protruding ftom an upper face;

b, a pair of opposing proximate extensions adjacent said recessed well; c, a distal raised platform adjacent said recessed well; and

d, , a fo!donl label aligned between said proxim te extensions and said distal raised platform,, wherein said fb!dont label having a collapsible notatio tab hinged about, a perforated fold.

16, The device of Claim 15_» wherein said ib!doei label includes a peel tab positioned along a bottom portion of said plate and adapted to removably separate a portion of said label to expose said recessed well.

17. Hie device of Cl aim I S . wherein said notation tab aligns parallel, to said fbldont label's upper side in a stationary position d pivots substantially one hundred and ei hty degrees about said perforation fold in an operation position.;

18. Tne device of Claim 15, wherein sa notation tab overlies said foldcnat label m a stationary position and Mages in a operation position.

19. The device of Cla m 15, wherein said notation tab includes at least one of a group 5 consisting of an inner notation face, an outer notation face, and a secondary

adhesive adapted to rdsaseably secure said. notation: tab about said fb out label in a stationary position.

20. The deviee according to any preceding elaim wherein a culture jaediom being: ! 0 secured in a recessed well.