Comparison of flocked and aptima swabs and two specimen transport media in the aptima combo 2 assay.

Self-collected vaginal Aptima swabs and flocked swabs in Aptima specimen transport medium and ESwabs in ESwab medium detected all 37 Chlamydia trachomatis-infected patients from 287 women tested by the Aptima Combo assay. Prevalence rates of C. trachomatis, Neisseria gonorrhoeae, and dual infection were 12.8%, 3.1%, and 2.4%, respectively.

Self-collected swabs of the urinary meatus diagnose more Chlamydia trachomatis and Neisseria gonorrhoeae infections than first catch urine from men.

OBJECTIVES: To compare first catch urine (FCU) and self-collected urinary meatal swabs for the detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) using the APTIMA Combo 2 assay. METHODS: A total of 511 young men from a high risk street youth clinic were studied. Group A (n=293) collected a FCU and a meatal APTIMA swab followed by Group B (n=218) who collected a FCU and two meatal samples using an APTIMA swab and a flocked swab. Order of sample collection was alternated. Individuals in Group B rated collection as easy, difficult or neither, then expressed a preference for sampling and swab type. All subjects performed meatal self-collection in the presence of a study monitor. RESULTS: The combined CT prevalence was 7.8% and 2.7% for NG where 80% of the men were without symptoms. Meatal swabbing identified 35 cases of CT and 14 cases of NG compared to 33 and 11 for FCU. Flocked and APTIMA swabs were equally effective in detecting more cases. The majority of men found self-collection of meatal swabs and urine to be easy. Although 63% preferred urine sampling, 60% of those who preferred swabbing selected the flocked swab. CONCLUSIONS: Collection of meatal swabs could serve as an alternative to urethral swabbing and FCU for the detection of CT and NG.

Validation of the APTIMA Combo 2 assay for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae in SurePath liquid-based pap test samples taken with different collection devices.

Mocked samples of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) diluted in SurePath liquid-based Pap (L-Pap) fluid were detected by the APTIMA Combo 2 assay to end points 10-fold greater than dilutions in specimen transport media. Pooled L-Pap clinical specimens yielded CT-positive results after storage at room temperature for 10 days. Based on an infected patient standard for comparison, cervical swabs, urine, and SurePath L-Pap test samples collected with a SurePath cervical broom or ThinPrep cytobrush from 520 women then tested by APTIMA Combo 2 assay, detected 25 (4.8%) with CT, 5 (1.0%) with (GC), and 3 (0.6%) with both. Percent sensitivities (80-84), specificities (99.8-100), positive (99.5-100) and negative (99.2-99) predictive values of SurePath L-Pap for CT were validated as similar to those reported in a previously published multicenter trial. All values for GC were 100%. One collection device was not significantly better than the other.

High analytical sensitivity and low rates of inhibition may contribute to detection of Chlamydia trachomatis in significantly more women by the APTIMA Combo 2 assay.

The clinical sensitivity of nucleic acid amplification tests may be determined by analytical sensitivity and inhibitors in patient samples. We established endpoints for detection of propagated Chlamydia trachomatis L2 434, diluted according to swab and urine protocols for APTIMA Combo 2 (AC2), ProbeTec ET (PT), and Amplicor (AMP) assays. AC2 was 1,000-fold more sensitive than PT and 10-fold more sensitive than AMP on mock swab specimens. For urine, AC2 analytical sensitivity was 100-fold greater than those of the other assays. Spiking an aliquot of each clinical-trial sample from 298 women demonstrated inhibition rates in first-void urine (FVU), cervical swabs (CS), and vaginal swabs (VS) of 12.1%, 12.8%, and 10.4% for AMP; 27.2%, 2%, and 2%, for PT; and 0.3%, 1.7%, and 1.3% for AC2. Inhibition of our C. trachomatis spike and the PT or AMP amplification controls from the manufacturers showed less than 50% correlation. Using an infected-patient reference standard (a specimen positive in at least two tests or a single test positive in two of three samples) in AC2, the VS identified 68/69 (98.6%) infected women compared to CS (89.9%) or FVU (81.2%). Significantly fewer women were identified by PT (65.2%, 63.8%, and 66.7%) or AMP (65.2%, 59.4%, and 56.5%) with the three specimens. By individual specimen type, AC2 confirmed virtually all PT- and AMP-positive specimens, but rates of AC2 confirmation by AMP or PT ranged from 62.9 to 80.3%. The AC2 test identified significantly more women infected with C. trachomatis (P = 0.001). Vaginal swabs appear to be the specimen of choice for screening.