Molecular Testing
Vials and collections kits are provided by request from Pathology Consultants, P.C. Supply Order Form.
CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE TESTING
These tests can be ordered individually or in combination. Acceptable specimen types are vaginal swab, endocervical swab, male urethral swabs, ThinPrep Pap vial, or urine.
For collection of endocervical and male urethral swab specimens, use the Aptima Unisex Swab Specimen Collection Kit. Only swabs provided with the collection kit should be used. Store at 2°C to 30°C until tested (stable 60 days). For longer storage, freeze at -20°C to -70°C (up to 12 months).
For urine collection, use only the Aptima Urine Specimen Vial for male and female urine specimens. After urine has been added to the preservative vial, the liquid level must fall between the two black indicator lines on the vial label. Urine in a sterile urine container can be submitted within 24 hours when stored at 2°C to 30°C.
For collection of vaginal swab specimens, use only the Aptima Multitest Swab Specimen Collection Kit.
PreservCyt solution has been validated as an alternative medium for testing with the Aptima GC assay. It must be processed within 30 days of collection when stored at 2°C to 30°C.
Limitations: Performance of this assay has not been validated in pregnant women and patients <16 years old.
TRICHOMONAS VAGINALIS
Acceptable specimen types are vaginal swab, endocervical swab, male urethral swabs, ThinPrep Pap vial, or urine. Vials and collection kits are available by request from Pathology Consultants. Supply Order Form.
For collection of endocervical and male urethral swab specimens, use the Aptima Unisex Swab Specimen Collection Kit. Only swabs provided with the collection kit should be used. Store at 2°C to 30°C until tested (stable 60 days). For longer storage, freeze at -20°C to -70°C (up to 12 months).
For urine collection, use only the Aptima Urine Specimen Vial for male and female urine specimens. After urine has been added to the preservative vial, the liquid level must fall between the two black indicator lines on the vial label. Urine in a sterile urine container can be submitted within 24 hours when stored at 2°C to 30°C.
For the collection of vaginal swab specimens, use only the Aptima Multitest Swab Specimen Collection Kit.
For specimens in PreservCyt solution, stable for 30 days when stored at 2°C to 30°C. After transfer to Aptima transfer vial, stable an additional 14 days at 15°C to 30°C or 30 days at 2°C to 8°C, and stable up to 2 months when frozen at ≤-20°C
HUMAN PAPILLOMA VIRUS (HPV)
Acceptable specimen type is cervical specimen collected into ThinPrep Pap vial containing PreservCyt solution. The specimen stability using a ThinPrep Pap vial is 105 days at 2°C to 8°C or 30 days at 9°C to 30°C. If transferred to Aptima Specimen Transfer vial, stable 24 months when frozen at -20°C to -70°C.
HERPES SIMPLEX VIRUS, 1 & 2 (HSV 1&2)
Acceptable specimen type is swab from anogenital lesions collected with Aptima Multitest Swab Specimen Collection kit, transferring swab into the provided Swab Transport Media (STM). Alternatively, the commercially available VTM Collection Kit (from Becton Dickenson), however these specimens must be transferred immediately after collection into an Aptima Transfer Tube containing STM media, taking precautions to avoid contamination. Specimens are stable in STM media for 36 days at 2°C to 30°C. Also stable 36 days when frozen at -20°C to -70°C. Swab samples may be frozen and thawed up to 3 times prior to testing.
VAGINAL PANEL (CANDIDA/TRICHOMONAS/BACTERIAL SPECIES)
Acceptable specimen type is a vaginal swab collected with the Aptima Multitest Swab Specimen Collection Kit. Refer to the appropriate specimen collection kit package insert for specific collection instructions. After collection, swab specimans in transport tubes can be stored at 2° to 30° C for up to 30 days, or 60 days at -20° to 70° C.
COLLECTION INSTRUCTIONS
Collect the specimen before any vaginal lubricant is used (e.g, prior to vaginal exam). Do not collect at the posterior fornix. If a speculum will be used, use only lukewarm water to lubricate the speculum if possible. If lubricant must be used, use sparingly and apply only to the exterior surfaces of the speculum blades.
Insert the swab 2″ into the vagina without touching the speculum, and rotate gently for 10-15 seconds. Remove and return to the swab to its tube so the tip is at the bottom, then break the shaft at the score mark and re-cap the vial. Label the vial with patient name, date and collection time.
For patient self-collection where gloves are not worn, wash hands with soap and water before collection. Insert the swab approximately 2″ into the vagina, then rotate for 10-15 seconds before removing. Avoid contact of the swab with external skin. Return the swab to its vial as described above.
