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

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...

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Bibliographic Details
Published in:PloS one 2012-02, Vol.7 (2), p.e32122-e32122
Main Authors: van der Helm, Jannie J, Sabajo, Leslie O A, Grunberg, Antoon W, Morré, Servaas A, Speksnijder, Arjen G C L, de Vries, Henry J C
Format: Article
Language:English
Subjects:
Acids
Adult
Bacteria
Biology
Cells (Biology)
Chlamydia
Chlamydia infections
Chlamydia Infections - diagnosis
Chlamydia Infections - microbiology
Chlamydia trachomatis
Chlamydia trachomatis - genetics
Clinics
Computed tomography
Corporate sponsorship
Cost analysis
Diagnostic systems
Disease transmission
Female
Health aspects
Health risks
Health services
Humans
Infections
Infectious diseases
Laboratories
Medical tests
Medicine
Neisseria gonorrhoeae
Nucleic Acid Amplification Techniques - methods
Pay-per-view television
Performance evaluation
Point-of-Care Systems - standards
Predictive Value of Tests
Public health
Reagent Strips
Sensitivity
Sensitivity analysis
Sensitivity and Specificity
Sexually transmitted disease prevention
Sexually transmitted diseases
Sexually Transmitted Diseases - diagnosis
Sexually Transmitted Diseases - microbiology
STD
Suriname
Trends
Vaginal Smears
Womens health
Young Adult
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Summary: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. 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. 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
ISSN:1932-6203
1932-6203
DOI:10.1371/journal.pone.0032122