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      Point-of-Care Test for Detection of Urogenital Chlamydia in Women Shows Low Sensitivity. A Performance Evaluation Study in Two Clinics in Suriname

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          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<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%).


          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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          Most cited references 31

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          Laboratory medicine in Africa: a barrier to effective health care.

          Providing health care in sub-Saharan Africa is a complex problem. Recent reports call for more resources to assist in the prevention and treatment of infectious diseases that affect this population, but policy makers, clinicians, and the public frequently fail to understand that diagnosis is essential to the prevention and treatment of disease. Access to reliable diagnostic testing is severely limited in this region, and misdiagnosis commonly occurs. Understandably, allocation of resources to diagnostic laboratory testing has not been a priority for resource-limited health care systems, but unreliable and inaccurate laboratory diagnostic testing leads to unnecessary expenditures in a region already plagued by resource shortages, promotes the perception that laboratory testing is unhelpful, and compromises patient care. We explore the barriers to implementing consistent testing within this region and illustrate the need for a more comprehensive approach to the diagnosis of infectious diseases, with an emphasis on making laboratory testing a higher priority.
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            Microfluidics-based diagnostics of infectious diseases in the developing world.

            One of the great challenges in science and engineering today is to develop technologies to improve the health of people in the poorest regions of the world. Here we integrated new procedures for manufacturing, fluid handling and signal detection in microfluidics into a single, easy-to-use point-of-care (POC) assay that faithfully replicates all steps of ELISA, at a lower total material cost. We performed this 'mChip' assay in Rwanda on hundreds of locally collected human samples. The chip had excellent performance in the diagnosis of HIV using only 1 μl of unprocessed whole blood and an ability to simultaneously diagnose HIV and syphilis with sensitivities and specificities that rival those of reference benchtop assays. Unlike most current rapid tests, the mChip test does not require user interpretation of the signal. Overall, we demonstrate an integrated strategy for miniaturizing complex laboratory assays using microfluidics and nanoparticles to enable POC diagnostics and early detection of infectious diseases in remote settings.
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              Point-of-care nucleic acid testing for infectious diseases.

              Nucleic acid testing for infectious diseases at the point of care is beginning to enter clinical practice in developed and developing countries; especially for applications requiring fast turnaround times, and in settings where a centralized laboratory approach faces limitations. Current systems for clinical diagnostic applications are mainly PCR-based, can only be used in hospitals, and are still relatively complex and expensive. Integrating sample preparation with nucleic acid amplification and detection in a cost-effective, robust, and user-friendly format remains challenging. This review describes recent technical advances that might be able to address these limitations, with a focus on isothermal nucleic acid amplification methods. It briefly discusses selected applications related to the diagnosis and management of tuberculosis, HIV, and perinatal and nosocomial infections. Copyright © 2011. Published by Elsevier Ltd.

                Author and article information

                Role: Editor
                PLoS One
                PLoS ONE
                Public Library of Science (San Francisco, USA )
                29 February 2012
                : 7
                : 2
                [1 ]STI Outpatient Clinic, Cluster Infectious Diseases, Public Health Service Amsterdam, Amsterdam, The Netherlands
                [2 ]Dermatological Service, Ministry of Health, Paramaribo, Suriname
                [3 ]Lobi Foundation, Paramaribo, Suriname
                [4 ]VU University Medical Center, Amsterdam, The Netherlands
                [5 ]Institute of Public Health Genomics, Department of Genetics and Cell Biology, Research Institutes CAPHRI and GROW, Faculty of Health, Medicine & Life Sciences, University of Maastricht, Maastricht, The Netherlands
                [6 ]Public Health Laboratory, Cluster Infectious Diseases, Public Health Service Amsterdam, Amsterdam, The Netherlands
                [7 ]Department of Dermatology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands
                [8 ]Centre for Infections and Immunity Amsterdam, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands
                [9 ]Centre for Infectious Disease Control, National Institute of Public Health and the Environment, Bilthoven, The Netherlands
                University of California San Francisco, University of California, Berkeley, and the Children's Hospital Oakland Research Institute, United States of America
                Author notes

                Conceived and designed the experiments: JvdH LS SM AS HdV. Performed the experiments: JvdH AG SM AS. Analyzed the data: JvdH SM HdV. Contributed reagents/materials/analysis tools: LS AG SM AS HdV. Wrote the paper: JvdH LS AG SM HdV.

                van der Helm et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
                Page count
                Pages: 7
                Research Article
                Diagnostic Medicine
                Global Health
                Infectious Diseases
                Sexually Transmitted Diseases
                Obstetrics and Gynecology
                Genitourinary Infections



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