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. | 14 days at 2°–30°C |
| Asymptomatic men: urine. | 90 days at −10°C or lower | |
| Symptomatic women: endocervical swab, clinician-collected vaginal swab, patient-collected vaginal swab in a clinical setting, and urine. | Thaw frozen specimens at 2°–30°C | |
| Symptomatic men: urethral swab and urine. | Specimens must not undergo more than four freeze/ thaw cycles | |
| Aptima COMBO 2 assay | Asymptomatic women: endocervical swab, clinician-collected vaginal swab, patient-collected vaginal swab in a clinical setting, gynecologic specimens collected in PreservCyt solution and urine. | 24 hours at 2°–30°C (urine specimen in primary cup) |
| Aptima CT assay | Asymptomatic men: urethral swab and urine. | 30 days at 2°–30°C (urine specimen in Aptima urine transport tube) |
| Aptima GC assay (Hologic/Gen-Probe Inc., San Diego, CA) | Symptomatic women: endocervical swab, clinician-collected vaginal swab, patient-collected vaginal swab in a clinical setting, gynecologic specimens collected in PreservCyt solution and urine. | 60 days at 2°–30°C (swab in Aptima swab transport tube) |
| Symptomatic men: urethral swab and urine. | 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. | 30 hours at 2°–30°C (urine specimen in primary cup) |
| Asymptomatic men: urethral swab and urine. | 7 days at 2°–8°C (urine specimen in primary cup) | |
| Symptomatic women: endocervical swab and urine. | 30 days at 2°–30°C (urine specimen in urine processing tube) | |
| Symptomatic men: urethral swab and urine. | 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 | Asymptomatic women: endocervical swab, patient-collected vaginal swab in a clinical setting, gynecologic specimens collected in BDSurePath or PreservCyt solution and urine. | 30 hours at 2°–30°C (urine specimen in primary cup). |
| BD ProbeTec QX GC Amplified DNA assay (Becton Dickinson and Company, Sparks, MD) | Asymptomatic men: urethral swab and urine. | 7 days at 2°–8°C (urine specimen in primary cup) |
| Symptomatic women: endocervical swab, patient-collected vaginal swab in a clinical setting, gynecologic specimens collected in BDSurePath or PreservCyt solution and urine. | 30 days at 2°–30°C (urine specimen in urine processing tube) | |
| Symptomatic men: urethral swab and urine. | 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. | 24 hours at room temperature (female urine specimen in primary cup) |
| Asymptomatic men: urine. | 3 days at room temperature (male urine specimen in primary cup) | |
| Symptomatic women: endocervical swab, patient-collected vaginal swab in a clinical setting, and urine. | 8 days at 4°C (female and male urine specimen in primary cup) | |
| Symptomatic men: urine. | 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. | ≤1 yr at 2°– 30°C (swab or urine specimen in cobas PCR media) |
| Asymptomatic men: urine. | 24 hrs at 2°–30°C (Neat male urine specimen prior to addition to cobas PCR media) | |
| Symptomatic women: endocervical swab, patient-collected vaginal swab in a clinical setting, clinician-collected vaginal swab, gynecologic specimens collected in PreservCyt solution and urine. | 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. | |
| Symptomatic men: urine |
*
FDA-cleared NAATs and specimen types as of January 1, 2014.