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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.

 
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