cobas PCR Cell Collection Media

Transcription

1 cobas PCR Cell Collection Media For Human papillomavirus detection (cobas 4800 HPV) Short guide for cervical sample collection using the Rovers Cervex-Brush and the cobas PCR Cell Collection Media 1,2 1. COLLE : Wear gloves. To collect, insert the central bristles of the broom into the endocervical canal. Insert the broom deep enough to allow the shorter bristles to fully contact the ectocervix. Push gently and rotate the broom in a clockwise direction five times. 2. RINS Rinse the broom into the cobas PCR Cell Collection Media by pushing the broom into the bottom of the vial ten times, forcing the bristles apart. Swirl the broom vigorously to further release the material. Discard the collection device. Do not leave the broom head in the vial. 3. CLOS Tighten the cap so that the torque line on the cap passes the torque line on the vial. The sample is now ready for transport. Precautions: Note that the specimen will be rejected if there is an excess of blood (more than 2% v/v). Such specimen appear bloody or have a dark brown color in the cobas PCR Cell Collection Media. Transport : between 2 C to 30 C Stability of sample : 6 months 1. Individuals collecting or directing the collection of samples should consult the complete instructions for use of the cobas PCR Cell Collection Media. 2. Individuals collecting or directing the collection of samples should consult the complete instructions for use of the Rovers Cervex-Brush Collection device COBAS is a trademark of Roche. Roche 2015.

2 cobas PCR Cell Collection Media FOR IN VITRO DIAGNOSTIC USE. cobas PCR Cell Collection Media 250 Tests P/N: cobas PCR Cell Collection Media is designed for use with Roche molecular based products including the AMPLICOR HPV Test, the LINEAR ARRAY HPV Genotyping Test and the cobas 4800 HPV Test. The cobas PCR Cell Collection Media is a methanol-based reagent that serves as a transport preservative and antibacterial medium for gynecologic samples. SUMMARY AND EXPLANATION cobas PCR Cell Collection Media is used to collect specimens to be tested by molecular PCR tests, including the AMPLICOR HPV Test, the LINEAR ARRAY HPV Genotyping Test and the cobas 4800 HPV Test. The patient s gynecologic specimen is collected by the clinician using a cervical sampling device, and is immersed and rinsed in the cobas PCR Cell Collection Media vial. The cobas PCR Cell Collection Media vial is then capped, labeled and sent to the laboratory for processing and testing with the PCR molecular test. PRINCIPLES OF PROCEDURE cobas PCR Cell Collection Media is a media used for collection and preservation of cells and DNA of patient specimens. When used for the Roche Diagnostics PCR products, it allows for detection of target DNA. COMPOSITION Methanol based, buffered preservative solution. WARNINGS FOR IN VITRO DIAGNOSTIC USE. Do not use reagent after its expiration date. Not for external or internal use in humans or animals. DANGER! May be fatal if swallowed. Vapor may be harmful if inhaled; use with adequate ventilation. May cause eye and skin irritation. Cannot be made non poisonous. PRECAUTIONS Wear gloves and eye protection when handling solution. Wash hands thoroughly after handling. Keep container closed when not in direct use. Keep away from heat, sparks and flame. Do not use if tamper evident seal on vial is broken or missing or if primary packaging is damaged. Dispose according to local regulations. Do not use wooden or other non-plastic devices for specimen collection. Do not detach the head of a broom-type collection device and place the head into the vial or leave the collection device standing in the solution. When transporting a cobas PCR Cell Collection Media vial containing cells, make sure the vial is tightly sealed. Align the mark on the cap with the mark on the vial to prevent leakage. The Document Revision Information section is located at the end of this document. AW EN 1 Doc Rev. 2.0

3 cobas PCR Cell Collection Media was challenged with a variety of microbial and viral organisms. Table 1 presents the starting concentrations of viable organisms and the number of viable organisms found after 15 minutes in cobas PCR Cell Collection Media. The log reduction of viable organisms is also presented. As with all laboratory procedures, universal precautions should be followed. PRETREATMENT No reconstitution, mixing or dilution is required. STORAGE Store cobas PCR Cell Collection Media without cellular specimens at 15 C to 30 C (59 F to 86 F). APPEARANCE AND INTEGRITY Clear, non-sterile solution. SPECIMEN COLLECTION AND PREPARATION Collect gynecologic specimens using a broom-type cervical collection device or endocervical brush/spatula combination collection device. Record required patient information in the space provided on the vial label. Brush/Spatula Collection Devices Collect specimens according to applicable instructions for use for the brush/spatula sampling device being used. Broom-Type Collection Device Collect specimens according to applicable instructions for use for the broom-type sampling device being used. Known interfering substances The use of lubricants (e.g. K-Y Jelly) should be minimized prior to specimen collection. Storage and Handling Store cobas PCR Cell Collection Media cellular specimen intended for detection of target DNA between 2 C (36 F) and 30 C (86 F) for up to 6 months. Consult the test-specific Roche package insert for details. PROCESSING INSTRUCTIONS Cellular specimens collected in cobas PCR Cell Collection Media are to be processed with Roche PCR products according to the Roche product package insert and the Roche Instrument Operator s Manuals. LIMITATIONS OF PROCEDURE cobas PCR Cell Collection Media cannot be substituted with any other solution for specimen collection, preparation, or processing. PERFORMANCE CHARACTERISTICS Refer to the Roche PCR test package insert. FIRST AID MEASURES If ingested, seek medical assistance immediately. If inhaled, move person to fresh air. If symptoms arise, seek medical assistance. AW EN 2 Doc Rev. 2.0

4 TABLE 1 Organism Initial Concentration Concentration after 15 minutes Log Reduction Candida albicans 1.1 x 10 6 CFU/mL <10 CFU/mL >5.0 Aspergillus niger 6.7 x 10 5 CFU/mL <10 CFU/mL >4.8 Escherichia coli 5.5 x 10 6 CFU/mL <10 CFU/mL >5.7 Staphylococcus aureus 5.0 x 10 6 CFU/mL <10 CFU/mL >5.7 Pseudomonas aeruginosa 2.1 x 10 6 CFU/mL <10 CFU/mL >5.3 Mycobacterium tuberculosis 7.0 x 10 6 CFU/mL <100 CFU/mL >4.8 Rabbitpox virus 1.2 x 10 8 PFU/mL <20 PFU/mL >6.8 HIV x 10 7 TCID 50 /ml 3 TCID 50 /ml >7.3 AW EN 3 Doc Rev. 2.0

5 Document Revision Information Doc Rev /2011 STORAGE AND HANDLING section was updated to indicate specimens collected in PCR Cell Collection Media intended for detection of target DNA can be stored at 2-30 C for up to 6 months. Please contact your local Roche Representative if you have any questions. Manufactured for Roche Molecular Systems, Inc., Branchburg, NJ USA A Member of the Roche Group Roche Diagnostics (Schweiz) AG Industriestrasse Rotkreuz, Switzerland Roche Diagnostics 2, Avenue du Vercors Meylan, France Roche Diagnostics GmbH Sandhofer Straße Mannheim, Germany Distributore in Italia: Roche Diagnostics S.p.A. Viale G. B. Stucchi Monza, Milano, Italy Roche Diagnostics, SL Avda. Generalitat, E Sant Cugat del Vallès Barcelona, Spain Distribuidor em Portugal: Roche Sistemas de Diagnósticos Lda. Estrada Nacional, Amadora, Portugal Roche Diagnostics 201, boulevard Armand-Frappier H7V 4A2 Laval, Québec, Canada (For Technical Assistance call: Pour toute assistance technique, appeler le: ) Roche Diagnostica Brasil Ltda. Av. Engenheiro Billings, 1729 Jaguaré, Building São Paulo, SP Brazil ROCHE, COBAS, AMPLICOR and LINEAR ARRAY are trademarks of Roche. K-Y is a trademark of Johnson & Johnson Corporation. 5/2011 AW Rev. 002 Doc Rev. 2.0 AW EN 4 Doc Rev. 2.0