TABLE 1.
PCE EIA resultb | Cobas PCR result | Commentc | Final report |
---|---|---|---|
+ | + | True positive | |
NGZ | + | True positive | |
− | + | If confirmatory NAAT on 2nd aliquot is positive | True positive |
+ | − | If confirmatory NAAT on 2nd aliquot is positive | True positive |
NGZ | − | If confirmatory NAAT on 2nd aliquot is positive | True positive |
− | + | If confirmatory NAAT on 2nd aliquot is negative | True negative |
+ | −d | If confirmatory NAAT on 2nd aliquot is negative | True negative |
NGZ | −d | If confirmatory NAAT on 2nd aliquot is negative | True negative |
− | −d | True negative |
Adapted from section 10 of the Chlamydia Screening Studies Laboratory Protocol (www.chlamydia.ac.uk/evaldiag.htm) with permission.
NGZ, negative gray zone.
Original urine was tested by confirmatory NAAT if the volume allowed it (1 ml was required for real-time PCR). Otherwise, the residual urine was used.
Internal control used to detect inhibitory specimens. Inhibitory specimens were retested by using a second NAAT (see Materials and Methods).