IES86486Y1 - A sample collection and shipping apparatus - Google Patents

Description

A sample collection and shipping apparatus” Introduction This invention relates to an apparatus for the collection of samples from cervical smear tests and distribution thereof.

Background Cervical cancer remains one of the most common types of cancer affecting women worldwide.

The biological pathway to cervical carcinoma begins with normal intraepithelial cells, and develops through low grade to high grade dysplavia bcforc malignancy.

Cervical cancer screening is commonly based on cytological analysis. The cervical smear text (Papanicolaou test or Pap smear} has led to the reduction in the incidences of and mortalities caused by cervical cancer. In the cervical smear test, a sample of cervical cells are collected from a patient for examination. The collected cells are placed on a glass slide, stained and examined by a specially-trained and qualiticd cytologist using a light microscope to identify cellular abnormalities.

One of the most important risk factors in the development of cervical cancer is human papillomavirus (HPV) infection. Although over 100 strains of I~IPV have been identified. only a subset are classified as high risk (l6. E8, 31, 33, 35. 39. 45, SI, 52. 56, 58, 59. 68. ?3 and 82) or probable high risk (26, 53 and 66) l_}'pt’:S (Munoz et al NETM, 348:518-527. 2003). 01'' these HPV types. lIPVl6 and HPV l 8 are reported to cause nearly 70% of all cervical cancer cases.

I-IPV-induced cervical cancer involves the following steps: (1) initial HPV infections. (2) persistent HPV infection, (3) tr-an.~a1’orming HPV infection, (4) development of pro-cancerous lesions and (5) development of invasive cancer. Some HPV infections resolve on their own or are suppressed by the immune system without causing serious pathology such as advanced cervical disease including cervical intraepithclial neoplasia 2 (CIN 2 or CIN II). cervical intraepithelial neoplasia 3 (CIN 3 or CIN III) and invasive cancer. When advanced cervical disease is detected intervention is required often involving removal of the trans!-‘ormation zone from the patients cervix for example by loop excision or cone biopsy. More radical procedures are required when carcinoma is detected. 886486 SCREUZ/C/[ES 2 The progression from normal to malignancy is not strict and the presence of low grade dysplasia docs not necessarily indicate that the patient will progress to high grade dysplasia or malignancy.

Cytological analysis of patent samples is subjective. Low grade dysplasia may be misdiagnosed as high grade dysplasia or high grade dysplasia may be misdiagnosed as low grade dyspiasia. It is also time consuming in terms ofsample preparation and analysis.

There is 21 need for 21 sample Collection and shipping kit for use with molecular llPV testing system.

Statements of invention According to the invention there is provided a sample collection and shipping apparatus for vials used in molecular human papillomavirus (HPV) testing, the apparatus comprising: an outer container, groups of sample collection components located within the outer container for collecting samples, each group of collection components comprising a collection device, :1 corresponding vial containing 2! preservative liquid for receiving the sample from the collection device, a corresponding requisition form and vial label for completion with information pertaining to the sample, and groups of shipping packaging components located within the outer container for packaging collected samples for shipping to a laboratory for HPV analysis, the shipping packaging components comprising a shipping carton for receiving a shipping container having absorbent material For packaging one or more vials containing samples and corresponding requisition forms for shipping to a laboratory for analysis.

In one embodiment the shipping container comprises a llexible scalable bag.

In one embodiment the shipping container comprises a zip lock bag containing a body of absorbent material.

$CRl'-.'tJ21CJl ES 3 in one case the apparatus comprises a vial label at least portion of which is removable for attachment to a requisition form. In one embodiment the requisition form has a defined region for reception of the vial label part.

The collection device may comprise a collection brush or a collection spatula.

In another aspect the invention provides a method for the collection and shipping of a sample for HPV analysis comprising the steps of: distributing to a sample collection site, a sample collection and shipping apparatus of the invention using a group of sample collection components to collect a sample, and using a group of return packaging components to package said collected sample for shipment from the sample collection site to a I-IPV testing site.

Brief Description ofthe Drawings The invention will be more clearly understood from the following description of some embodiments thereof, given by way of example only with reference to the accompanying drawings in which:- Fig. l is an exploded perspective view ofa sample collection apparatus ofthe invention; Fig. 2 is a plan view from above of the apparatus ot'Fig. 1 assembled; Figs 3(a) and 3(b) are perspective views of the sample collection components of the apparatus of Figs. 1 and 2; Figs. 4(a) and 4(1)) are detailed perspective views of a shipping packaging components of the apparatus; SC R l.".0'UC:' I [55 4 Figs. 5(a) and 5(b) are detailed perspective views of the shipping packaging components being prepared for shipping; Figs. 6(a), 6(b) and 6(c) are perspective views of alternative shipping packaging components ofthc invention; Fig. 7 is a perspective view of covering material; Fig. 8 is an illustration ofthc step of applying covering material to a shipping packaging carton in preparation for reuse; and Fig. 9 is a diagram illustrating the steps of the system of distribution of the apparatus of the invention.

Detailed Description This invention provides a kit with all of the necessary components for a sample taker to obtain a patient sample in a clinical setting and then to return the sample to a molecular laboratory for HPV screening using the postal service or other form of courier.

I-lPVl6 and HPV I 8 have been reported to cause nearly 70% ofall cervical cancer cases. Patient samples can be screened for the presence of high risk l-IPV subtypes using for example molecular methods such as PCR or samples can be screened for the expression of proteins or biomarkers associated with high risk HPV subtype infection. Patient samples that test positive for high risk l-IPV subtypes may be analysed furtlter using traditional cytological analysis. initial screening of samples for high risk l-IPV subtype infection will enable patients to be stratified into two groups: positive or negative for high risk I-IPV subtype infection. This initial screen will streamline the number of patient samples that may require further cytological analysis.

During a cervical smear test, a sample of cells is collected from the surface of the cervix using a cervix brush or spatula (collection device). When the sample has been obtained, the collection device is placed into a vial containing a preservative liquid. scru=,02/cm-is Once collected, the sample is transported in the liquid based via] to a molecular laboratory where the sample can be tested for the presence of HPV using several different known analysis techniques. A preservative liquid is used as a collection medium for the preservation and transport of the sample.

The kit of the invention contains the following: I) A tray of vials containing a preservative liquid for the collection of the HPV sample. The collections vials have the option ofa unique identifier number included. In one variation this is in the form of a peel off sticker which can be attached to a patient request form after the sample is taken. 2) A pack of cervix brushes (used to collect the sample) or individually wrapped cervix brushes. 3) A pad of patient request forms, used by the sample taker to enter the patient details etc. (in one variation the forms will have the option for the user to attach a peel off sticker to track the unique identifier on the vial). 4) A quantity of return packaging that can be used to return the sample to the molecular laboratory. The return packaging will come in a variety of sizes to suit the sample takers volumes. There is primary leakproof receptacle, a secondary ieakproof receptacle. and an outer packaging. The return packaging meets the requirements of the ADR for the transport of samples in accordance with UN3373, Diagnostic Specimen Category B.

The primary receptacle vial is robust with a screw on cap and torque line to ensure that it is tightened correctly. In one variation the vial is pressure tested to ensure 95 kPa integrity while in another variation the vial includes a unique identifier that may be in the form of a peel of sticker that can be attached to the patient consent form. The vial contains a preservative liquid suitable for transporting the I-IPV sample.

The secondary packaging includes an absorbent" material insert having a hollowed out portion shaped for conformity with a vial to support a vial containing sample therein. There is also a base liner to protect the vial. The foam insert and base liner is committed within a leak proof type plastic bag that can be sealed at the top. in one variation this bag is testing to ensure 95 kPa integrity.

SCRE02IC/[ES 6 The outer container is sized to lit a number of samples, the secondary packaging and the relevant cytology forms compactly. The packaging is suitable for transporting one or more samples to the molecular laboratory for testing.

The return packaging comes in various sizes to allow for high volume and low volume sample takers.

Referring to Figs. I and 2 a composite sample collection and shipping apparatus 1 coinprises an outer distribution container 2 packed with one or tnore groups of sample collection components and one or more groups of return packaging components. The groups of sample collection components facilitate collection of samples at a sample collection site. The groups of return packaging components facilitate packaging of collected samples for shipping from the sample collection site to one or more laboratories for HPV testing.

Each group of sample collection components comprises a vial 3 containing at preservative liquid, a brush 4, an I-IPV analysis request form 7, and an IIPV analysis vial label 8. The vial labels 8 are in place on the vials 3. The apparatus 1 also includes instruction literature and a vial support stand. 1'-Lach group of return packaging components comprises a shipping eatton 9, zip lock plastic bag containing a body 14 of absorbent material I3 and 14. and a return shipping label 10.

The apparatus I includes a plurality of groups of sample collection components and shipping components. The apparatus 1 ensures that the medical user at the sample collection site is equipped to collect samples over time and has sufficient shipping components to enable packaging and shipping of the samples as they are collected.

The components of the apparatus I ma}-' be stored in the outer container 2 until requincd for use.

The outer container 2 is designed to enable secure catriage of the sample collection apparatus I to a I-IPV testing site. As shown in Fig. 2, when the outer container 2 is packed the components fit securely therein and are prevented fi'om being displaced and damaged during carriage.

Additional packaging may be provided if required.

$('Rl’.02f('.-‘IE5 The composite apparatus I meets the regulations for the carriage of buffered methanol liquids.

The vials 3 are supported in trays 1] for distribution and storage purposes. 'l'he vials and trays are sealed. The vial 3 comprises a plastic container with a lid 12.

The sample collection devices and vials are sterilised and retained in sterilised packaging 5 and until required for use.

Referring to Figs. 3(a) and 30)] some ofthe steps ofcollecting a sample and packaging a sample for shipping are shown. A single vial 3 is removed front the tray 1 l and a single brush 4 is nemoved from the multiple brush pack 5. The sample, in this case a smear test sample. is collected by medical personnel using a brush 4 and is transferred into the via] 3 which is then sealed. The vial label 8 is completed. The medical user completes a corresponding laboratory test request form 7 which is packaged with the labelled vial.

Referring to Figs. 4(a) and 4(1)) the labelled vial 3 is then packaged into a return container 9 for shipping. The return container‘) is designed to receive and support a number of sample The absorbent base 14 acts as protective padding. The analysis request forms 7 corresponding to the containing vials 3. The container 9 has an absorbent base 14 to support the vials 3. sample containing vials are also accommodated in the container 9. Instrttetions or labelling may be printed on the container 9.

Referring to Figs. 5(a) and Slb) the shipping iabel 10 complete with shipping address information 18 is applied to the container 9. Containers 2 and cartons 9 are sttftieiently robust that they securely contain the various components and furthermore withstand the wear and tear of use and reuse.

A sample collection and shipping apparatus I may be assembled using return containers 9 of different sizes selected based on test site nequitentcnts. The outer container 2 may be packed with containers 9 of the same size or of different sizes to provide for handling different and changing numbers of samples collected at a sample collection site.

The system of the invention provides means for the distribution, shipment, collection and recycling of the components 9, 13 and 14 ofthe apparatus 1.

S C RE02/C.-‘l E S 8 Referring to Figs. 7 and 8 a roll 20 of adhesive covering material is illustrated. The covering comprises stickers 2] for placing over markings on an exterior face of a used return container 9 to enable reuse of the container. Stickers 2| of appropriate size and layout are provided. The stickers are manufactured of any suitable material such as a plastics or paper material. The stickers may be opaque to provide increased confidentiality.

Referring to Fig. 9 the main steps of the system of the invention are described.

The sample collection and shipping apparatus 1 is assembled at a distribution centre for supply to a sample collection site. If, in general the sample collection sites handles only a few samples per day then a small sized sample collection and shipping apparatus I packed with small sized return shipment cartons 9 may be most appropriate. The sample collection site selects and orders a sample collection and shipping apparatus as required.

The steps involved in the distribution of the sample collection apparatus, shipment ofsamples, collection and recycling of the components are as follows: I. Sample collection apparatus 1 is distributed to a sample collection site.

Ii. Samples are collected at a sample collection site. A sample collection device from the apparatus 1 is used to collect a sample which is 1'ransieri‘ed to a corresponding vial 3 containing preservative liquid. A corresponding request fonn 7‘ is completed and the vial label 8 completed. in the embodiment shown, the vials 3 are supplied with the labels 8 in place. I-lowcvcr, it will be appreciated that the labels may be provided separately or integrally with the request form. if the label is provided separately then the completed label is attached to the vial. ill. The items to be transported to a laboratory for processing namely, the vial containing the sample and the corresponding request form are packaged into a shipping canon 9 for shipment to one or more laboratories for processing. The container 13 housing sample SCRE02:'C!lFI$ 9 containing vials are placed in the carton 9 and the requisition or request form is placed in the carton which is then sealed.

IV. The shipment carton 9 is then transported to a laboratory by any suitable means.

V. At the laboratory, sample containing vials are removed from the carton 9 for p1'oces$ing.

The shipping components are retained for collection.

VI. The used shipping components are collected from the laboratories and returned to a distribution centre. The shipping canons 9 are recycled.

The recycling process involves the steps of inspecting the components and replacing any damaged foam or cartons. Stickers 2] may be applied to the container 9 to cover previous carriage marks. Additional blank stickers may be used to cover any further marks on the carton.

Vll. Sample collection apparatus 1 is assembled for distribution to a test site.

A distribution centre handles the supply to sample collection sites of the sample collection apparatus. The sample collection sites and processing laboratories are independent entities and the samples are typically shipped between them by independent means. The apparatus l conforms to the requirements for shipping medical fluids. and so do samples shipped using the shipping components supplied with the sample collection and distribution apparatus.

The invention overcomes the problems of the prior art by providing means for the secure distribution of sample collection and shipping apparatus and shipment of collected liquid cytology samples from sample collection sites for IIPV testing. The system is flexible and takes account of the reality that ditferetit test sites handle different numbers of liquid cytology samples and therefore have different requirements.

The apparatus of the invention and the system for the distribution of the apparatus and shipment of collected samples answers the requirements of different sized GP (General Practitioner) SC REO 7JCn as I 0 surgeries where the number of liquid Samples collected may vary from day to day and where the overall number of samples collected may be limited.

The apparatus is also designed to cater for multiple laboratories. Each sample collection and shipping apparatus includes multiple shipping components and samples may be shipped from a sample collection site to multiple laboratories. 'lhe apparatus and the components are acceptable for use across a wide range of sample collection sites and laboratories. The system provides excellent flexibility.

The medical user or (SP is provided with all of the components required for collecting a liquid sample and returning the sample in the apparatus. The components required for taking samples are sterilised and are retained in sterilised packaging until required for use. The kit is supplied complete with shipping components which conform with requirements and regulations For the shipment of medical samples and are appropriate for use by third party delivery firms. A sample collection site need not be concerned with the task of independently procuring packaging for shipping the liquid cytology samples.

Depending on requirements of the test site, it is possible to select the components to be included in a sample collection and shipping apparatus, with flexibility. For example, if only a limited number of liquid samples are typically taken at a particular site then that site may be supplied with an apparatus having a greater number of small sized shipment cartons.

The composite apparatus of the invention has the additional advantages that it is easy to Store and that all required elements are stored together as supplied in sterilised paclmgiitg. The apparatus is self contained and all the components required for taking samples and sending them to the laboratory are conveniently at hand for the medical user or GP.

The shipment cartons are sufficiently robust to enable recycling. Also the use of robust cartons better serves the requirements for secure support and handling of the liquid Cytology sample containing vials.

The recycling process makes distribution highly economical. The system provides for ease in repackaging and facilitates multi-party distribution. s(.'ru=.a2x(:m.-:s I 1 The invention is not limited to the embodiment hereinhefore described, with reference to the accompanying drawings, which may be varied in construction and detail.

Claims (1)

1. Claims SCRIEUZICJIES A sample collection and shipping apparatus for vials used in molecular human papillomavirus {HPV} testing, the apparatus comprising: an outer conutiner, groups of sample collection components located within the outer container for collecting samples, each group of col leetion components comprising a collection device, a corresponding vial containing a preservative liquid for receiving the sample fl'om the col leetion device, a corresponding requisition form and vial label for completion with information pertaining to the sample, and groups of shipping packaging components located within the outer container for packaging collected samples for shipping to a laboratory for HPV analysis; the shipping packaging components comprising a shipping carton for receiving a shipping container having absorbent material therein for packaging one or more vials containing samples and correspontling requisition forms for shipping to a laboratory for analysis. An apparatus as claimed in any preceding claim, wherein the shipping container comprises a flexible scalable bag, in one case the shipping container comprises a zip lock bag containing a body of absorbent material. An apparatus as claimed in any of claims 1 to 2 wherein the vial has a label at least portion of which is removable for attachment to a requisition form, the requisition form may have a defined region for reception of the vial label part. An apparatus as claimed in any preceding claim, wherein the collection device comprises a collection brush or a collection spatula. A method for the collection and shipping of a sample for HPV analysis comprising the steps of: 10 SCR F.02!(.‘/ l E 3 distributing to a sample col lcction site, a sample collection and shipping apparatus as claimed in any of claims 1 to 4 using a group of sample collection components to collect a sample, and using a group ofrctum packaging components 10 package said collected sample for shipment from the sample collection silo to a testing site.