Sample Modeling The Saxophones V1.1.1 Incl 23 !!BETTER!!
NAATs are highly sensitive, detecting more T. vaginalis infections than wet-mount microscopy among women (1060). The Aptima T. vaginalis assay (Beckton Dickinson) is FDA cleared for detection of T. vaginalis from symptomatic or asymptomatic women. Reliable samples include clinician-collected endocervical swabs, clinician-collected vaginal swabs, female urine specimens, and liquid Pap smear specimens collected in PreservCyt Solution (Hologic) (698,1088). This assay detects RNA by transcription-mediated amplification with a sensitivity of 95.3%100% and specificity of 95.2%100%, compared with wet mount and culture (1088,1089). Among women, vaginal swabs and urine specimens have 1084). This assay has not been FDA cleared for use among men and should be internally validated in accordance with CLIA regulations before use with urine or urethral swabs from men. The Probe Tec TV Qx Amplified DNA Assay (Becton Dickinson) is FDA cleared for detection of T. vaginalis from vaginal (patient-collected or clinician-collected) swabs, endocervical swabs, or urine specimens from women and has sensitivity of 98.3% and specificity of 99.6%, compared with wet mount and culture (1090). Similar to the Aptima T. vaginalis assay, this test is only FDA cleared for use among women and should be internally validated for use with men. The Max CTGCTV2 assay (Becton Dickinson) is also FDA cleared for detection of T. vaginalis in patient-collected or clinician-collected vaginal swab specimens and male and female urine specimens, with sensitivity and specificity of 96.2%100% and 99.1%100%, respectively, depending on the specimen type, compared with wet mount and culture (1091). GeneXpert TV (Cepheid) is a moderately complex rapid test that can be performed in 1 hour and can be used at the POC (1092). It has been FDA cleared for use with female urine specimens, endocervical swabs, patient-collected or clinician-collected vaginal specimens, and male urine specimens, with sensitivity and specificity of 99.5%100% and 99.4%99.9% (1007), respectively, compared with wet mount and culture.
sample modeling the saxophones v1.1.1 incl 23