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. 2012;7(2):e32122.
doi: 10.1371/journal.pone.0032122. Epub 2012 Feb 29.

Point-of-care test for detection of urogenital chlamydia in women shows low sensitivity. A performance evaluation study in two clinics in Suriname

Jannie J van der Helm  1 , Leslie O A Sabajo, Antoon W Grunberg, Servaas A Morré, Arjen G C L Speksnijder, Henry J C de Vries
Affiliations

Point-of-care test for detection of urogenital chlamydia in women shows low sensitivity. A performance evaluation study in two clinics in Suriname

Jannie J van der Helm et al. PLoS One. 2012.

Abstract

Background: In general, point-of-care (POC) tests for Chlamydia trachomatis (Ct) show disappointing test performance, especially disappointing sensitivity results. However, one study sponsored by the manufacturer (Diagnostics for the Real World) reported over 80% sensitivity with their Chlamydia Rapid Test (CRT). We evaluated the performance of this CRT in a non-manufacturer-sponsored trial.

Methods: Between July 2009 and February 2010, we included samples from 912 women in both high- and low-risk clinics for sexually transmitted infections (STIs) in Paramaribo, Suriname. Sensitivity, specificity, positive- and negative predictive values (PPV and NPV) for CRT compared to NAAT (Aptima, Gen-Probe) were determined. Quantitative Ct load and human cell load were determined in all CRT and/or NAAT positive samples.

Results: CRT compared to NAAT showed a sensitivity and specificity of 41.2% (95% CI, 31.9%-50.9%) and 96.4% (95% CI, 95.0%-97.5%), respectively. PPV and NPV were 59.2% (95% CI, 47.5%-70.1%) and 92.9% (95% CI, 91.0%-94.5%), respectively. Quantitative Ct bacterial load was 73 times higher in NAAT-positive/CRT-positive samples compared to NAAT-positive/CRT-negative samples (p<0.001). Human cell load did not differ between true-positive and false-negative CRT results (p = 0.835). Sensitivity of CRT in samples with low Ct load was 12.5% (95% CI, 5.2%-24.2%) and in samples with high Ct load 73.5% (95% CI, 59.9%-84.4%).

Conclusions: The sensitivity of CRT for detecting urogenital Ct in this non-manufacturer-sponsored study did not meet the expectations as described previously. The CRT missed samples with a low Ct load. Improved POC are needed as meaningful diagnostic to reduce the disease burden of Ct.

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Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist.

Figures

Figure 1
Figure 1. Flow chart of specimen collection for the evaluation of a Chlamydia Rapid Test test as diagnostic for urogenital chlamydia in women at two study sites in Paramaribo, Suriname, from July 2009 to February 2010.
NAAT; Aptima chlamydia single test, Genprobe (control test) CRT; Chlamydia Rapid Test, Diagnostics for the Real World (evaluated test).
See this image and copyright information in PMC

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