Trichomonas vaginalis / Mycoplasma genitalium (PCR)

1. The presence of mucus in endocervical specimens may cause processing delays due to clotting. Mucus free specimens are required for optimal test performance. Use the large woven polyester swab in the cobas® PCR Dual Swab Sample Kit or an equivalent device to remove cervical secretions and discharge before obtaining the endocervical specimen.
2. Use only the flocked swab in the cobas® PCR Media Dual Swab Sample Kit to collect endocervical specimens. Use only the woven polyester swab in either the cobas® PCR Media Dual Swab Sample Kit or the cobas® PCR Media Uni Swab Sample Kit to collect vaginal swab specimens. cobas® TV/MG has not been validated for use with other swab collection devices or media types. Using cobas® TV/MG with other swab collection devices or media types may lead to false negative, false positive, and/or invalid results.
3. To avoid cross contamination of processed specimens, additional caps for cobas® PCR Media tubes in an alternate color (neutral; see Additional materials required for sample aliquoting and sample loading for cobas® TV/MG) should be used to recap specimens after processing.
4. All swab specimens containing a single swab in the cobas® PCR Media tube can be directly processed on the cobas® 6800 System. If desired, the swab may be removed before the specimen tube is loaded onto the instrument, however utmost care must be exercised to avoid cross contamination.
5. A properly collected swab specimen should have a single swab with the shaft broken at the scoreline. Swab shafts which are broken above the score line will appear longer than normal and may also be bent over to fit into the cobas® PCR Media tube. This can create an obstruction to the pipetting system which may cause the loss of sample, test results and/or mechanical damage to the instrument. In the event that a swab specimen has an improperly broken shaft, remove the swab prior to sample processing on the cobas® 6800 System. Use caution when disposing of specimen swabs; avoid splashing or touching swabs to other surfaces during disposal to prevent contamination.
6. Incoming primary swab specimen tubes with no swabs or with two swabs have not been collected according to the instructions in their respective collection kit IFU and should not be tested.
7. Occasionally, incoming swab specimens contain excessive mucus which may induce a pipetting error (e.g., clot or other obstruction) on the cobas® 6800 System. Prior to retesting of specimens that exhibited clots during initial processing, remove and discard the swab, then re-cap and vortex these specimens for 30 seconds to disperse the excess mucus.
8. Swab specimens can be assayed twice on the cobas® 6800 System while the swab is in the collection tube. If additional testing is required, or if the first test fails due to specimen pipetting error (e.g., clot or other obstruction), the swab must be removed and the remaining fluid must have a minimum volume of 1.0 mL.

1. Use only the cobas® PCR Urine Sample Kit to collect urine specimens for cobas® TV/MG. cobas® TV/MG has not been validated for use with other urine collection devices or media types. Using cobas® TV/MG with other urine collection devices or other media types may lead to false negative, false positive, and/or invalid results.
2. To avoid cross contamination of processed specimens, additional caps for cobas® PCR Media tubes in an alternate color (neutral; see Additional materials required for sample aliquoting and sample loading for cobas® TV/MG) should be used to recap specimens after processing.
3. Untested urine specimens must show the top of the liquid level between the two black lines on the cobas® PCR Media tube label window. If the liquid level is above the upper or below the lower line, the specimen has not been collected properly and cannot be used for testing.
4. If additional testing is required, ensure that there is at least 1.2 mL of specimen remaining the in cobas® PCR Media tube.

Trichomonas vaginalis: Negative
Mycoplasma genitalium: Negative