TABLE 2. Food and Drug Administration–cleared* specimen types and requirements for the transport and storage of specimens for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae by nucleic acid amplification test (NAAT) type
FDA-cleared NAAT |
FDA-cleared specimen types |
Specimen transport and storage conditions |
---|---|---|
Abbott RealTime CT/NG (Abbott Molecular Inc., Des Plaines, IL) |
Asymptomatic women: clinician-collected vaginal swab, patient-collected vaginal swab in a clinical setting, and urine. Asymptomatic men: urine. Symptomatic women: endocervical swab, clinician-collected vaginal swab, patient-collected vaginal swab in a clinical setting, and urine. Symptomatic men: urethral swab and urine. |
14 days at 2°–30°C 90 days at -10°C or lower Thaw frozen specimens at 2°–30°C Specimens must not undergo more than four freeze/ thaw cycles |
Aptima COMBO 2 assay Aptima CT assay Aptima GC assay (Hologic/Gen-Probe Inc., San Diego, CA) |
Asymptomatic women: endocervical swab, clinician- collected vaginal swab, patient-collected vaginal swab in a clinical setting, gynecologic specimens collected in PreservCyt solution and urine. Asymptomatic men: urethral swab and urine. Symptomatic women: endocervical swab, clinician- collected vaginal swab, patient-collected vaginal swab in a clinical setting, gynecologic specimens collected in PreservCyt solution and urine. Symptomatic men: urethral swab and urine. |
24 hours at 2°–30°C (urine specimen in primary cup) 30 days at 2°–30°C (urine specimen in Aptima urine transport tube) 60 days at 2°–30°C (swab in Aptima swab transport tube) 12 months at -20° to -70°C (urine specimen and swab specimens in respective Aptima transport tubes) |
BD ProbeTec ET CT/GC Amplified DNA assay (Becton Dickinson and Company, Sparks, MD) |
Asymptomatic women: endocervical swab and urine. Asymptomatic men: urethral swab and urine. Symptomatic women: endocervical swab and urine. Symptomatic men: urethral swab and urine. |
30 hours at 2°–30°C (urine specimen in primary cup) 7 days at 2°–8°C (urine specimen in primary cup) 30 days at 2°–30°C (urine specimen in urine processing tube) 60 days at -20°C or lower (neat urine specimen or urine in urine processing tube) 6 days at 2°–27°C (swab specimens) 30 days at 2°–8°C (swab specimens) |
BD ProbeTec QX CT Amplified DNA assay BD ProbeTec QXGC Amplified DNA assay (Becton Dickinson and Company, Sparks, MD) |
Asymptomatic women: endocervical swab, patient-collected vaginal swab in a clinical setting, gynecologic specimens collected in BDSurePath or PreservCyt solution and urine. Asymptomatic men: urethral swab and urine. Symptomatic women: endocervical swab, patient-collected vaginal swab in a clinical setting, gynecologic specimens collected in BDSurePath or PreservCyt solution and urine. Symptomatic men: urethral swab and urine. |
30 hours at 2°–30°C (urine specimen in primary cup). 7 days at 2°–8°C (urine specimen in primary cup) 30 days at 2°–30°C (urine specimen in urine processing tube) 180 days at -20°C or lower (neat urine specimen or urine in urine processing tube) 30 days at 2°–30°C (endocervical and urethral swab specimens) 180 days at -20°C or lower (endocervical and urethral swab specimens) 14 days at 2°–30°C (dry vaginal swab specimens) 30 days at 2°–30°C (expressed vaginal swab specimens) 180 days at -20°C or lower (dry or expressed vaginal swab specimens) |
Xpert CT/NG assay (Cepheid, Sunnyvale, CA) |
Asymptomatic women: endocervical swab, patient-collected vaginal swab in a clinical setting, and urine. Asymptomatic men: urine. Symptomatic women: endocervical swab, patient-collected vaginal swab in a clinical setting, and urine. Symptomatic men: urine. |
24 hours at room temperature (female urine specimen in primary cup) 3 days at room temperature (male urine specimen in primary cup) 8 days at 4°C (female and male urine specimen in primary cup) 3 days at 15°–30°C (female urine specimen in Xpert CT/NG Urine Transport Reagent tube) 45 days at 2°–15°C (female urine specimen in Xpert CT/NG Urine Transport Reagent tube) 45 days at 2°–30°C (male urine specimen in Xpert CT/NG Urine Transport Reagent tube) 45 days at 2°–30°C (swab in Xpert CT/NG Swab Transport Reagent tube) |
cobas CT/NG test (Roche Diagnostics, Indianapolis, IN) |
Asymptomatic women: endocervical swab, patient- collected vaginal swab in a clinical setting, clinician- collected vaginal swab, gynecologic specimens collected in PreservCyt solution and urine. Asymptomatic men: urine. Symptomatic women: endocervical swab, patient- collected vaginal swab in a clinical setting, clinician- collected vaginal swab, gynecologic specimens collected in PreservCyt solution and urine. Symptomatic men: urine. |
≤1 yr at 2°– 30°C (swab or urine specimen in cobas PCR media) 24 hrs at 2°–30°C (Neat male urine specimen prior to addition to cobas PCR media) Cervical specimens collected in PreservCyt Solution may be stored at 2°–30°C for up to 12 months. Aliquots (≥1mL) of cervical specimens collected in PreservCyt Solution may be stored in 13 mL round-based Sarstedt tubes for up to 4 weeks at 2°–30°C. |
* FDA-cleared NAATs and specimen types as of January 1, 2014.