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Affirm™ VPIII Ambient Temperature Transport is a sterile ready-to-use system intended for the collection, transport and preservation of vaginal specimens for use only with the Affirm VPIII Microbial Identification Test. The Affirm VPIII Ambient Temperature Transport System (ATTS) should be used with those specimens where transport times are expected to exceed 1 h at ambient temperature (15 - 30°C) or 4 h at refrigerated temperatures (2 - 8°C).

One of the routine procedures in the use of the Affirm VPIII Microbial Identification Test involves the collection and stable transportation of a vaginal specimen from the patient to the laboratory. This can be accomplished using the Affirm VPIII Ambient Temperature Transport System.

The Affirm VPIII Ambient Temperature Transport System is designed to stabilize the nucleic acid of Candida species, Gardnerella vaginalis and Trichomonas vaginalis during specimen transport at ambient temperature (15 - 30°C) for up to 72 h. This system has also been qualified for transport use at 2 - 8°C. The ATTS Reagent Dropper contents are dispensed into the Sample Collection Tube. The patient vaginal specimen is immediately collected and the sterile swab containing the patient specimen is placed in the Sample Collection Tube containing the ATTS Reagent. The swab shaft is broken at the scored point and the top portion of the swab is discarded. The Sample Collection Cap is placed over the exposed end of the swab and is firmly seated on the Sample Collection Tube. The capped Sample Collection Tube is sealed in the outer bag of the Affirm VPIII Ambient Temperature Transport System and transported to the laboratory within 72 h.

For in vitro Diagnostic Use.

Specimens collected for transport with this procedure should be used only for testing with the Affirm VPIII Microbial Identification Test. This transport system was designed for use with those specimens where transport times are expected to exceed 1 h at ambient temperature or 4 h at refrigerated temperatures.

Patient specimen must be collected immediately after the ATTS Reagent has been dispensed into the Sample Collection Tube. DO NOT pre-dispense ATTS Reagent into the Sample Collection Tube.

ATTS Reagent: Substance is toxic and highly flammable. Irritating to eyes, respiratory system and skin. Use in a well-ventilated place. Keep away from sources of ignition – No smoking; Wear protective clothing and gloves.

Immediately remove any clothing soiled by the product.

If inhaled, supply fresh air or oxygen; consult Material Safety Data Sheet (MSDS) and seek medical advice.

After skin contact, immediately rinse with water.

After eye contact, rinse immediately with plenty of water, consult MSDS and seek medical advice.

WARNING: Pathogenic microorganisms, including hepatitis viruses and Human Immunodeficiency Virus, may be present in clinical specimens. "Standard Precautions"^1-4 and institutional guidelines should be followed in handling all items contaminated with blood and other body fluids.

Proper handling and disposal methods should be established. Wipe up any spillage of patient specimens immediately and disinfect with an appropriate disinfectant. Treat the cleaning materials as biohazardous waste.

The sterile swab should not be used if the packaging is opened or damaged.

BD Affirm VPIII Ambient Temperature Transport System is for single use only; reuse may cause a risk of infection and/or inaccurate results.

The Ambient Temperature Transport System should not be used if its foil pouch is open or the ATTS Reagent Dropper is damaged.

When specimen transport times exceed 72 h, a reduction in sensitivity may be observed.