Specimen Requirements

Specimen Collection and/or Timing

1. Must be obtained using the Cytyc Specimen Collection Kit or Rapid fFN kit for Full Term.

2. Test is intended for use between 22nd and 34.9 weeks (34 wks, 6 days) of pregnancy.

Criteria

Type -Preferred Cervicovaginal secretions on a Dacron swab, in buffer solution in securely capped tube;

swab and buffer tube are components of the Cytyc Specimen Collection Kit for Full Term.

-Other Acceptable None

Unacceptable Specimens

& Actions to Take

· Sample collected in or by any sample device other than the Cytyc Specimen Collection Kit for Full Term.

· Samples exceeding stability.

· Samples received at temperatures >25ºC

· Specimens received in expired transport.

· Specimens subjected to more than one freeze thaw cycle.

· Samples in transport tubes that have leaked

· Specimens exposed to glass