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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Published inPloS one Vol. 7; no. 2; p. 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 Journal Article
LanguageEnglish
Published United States Public Library of Science 29.02.2012
Public Library of Science (PLoS)
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
Suriname
Netherlands
Online AccessGet full text

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Abstract 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.
AbstractList 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.
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.
BackgroundIn 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.MethodsBetween 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.ResultsCRT 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%).ConclusionsThe 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.
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.
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.
Audience Academic
Author van der Helm, Jannie J
Grunberg, Antoon W
Morré, Servaas A
de Vries, Henry J C
Speksnijder, Arjen G C L
Sabajo, Leslie O A
AuthorAffiliation 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
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
University of California San Francisco, University of California, Berkeley, and the Children's Hospital Oakland Research Institute, United States of America
4 VU University Medical Center, Amsterdam, The Netherlands
9 Centre for Infectious Disease Control, National Institute of Public Health and the Environment, Bilthoven, The Netherlands
8 Centre for Infections and Immunity Amsterdam, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands
6 Public Health Laboratory, Cluster Infectious Diseases, Public Health Service Amsterdam, Amsterdam, The
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BackLink https://www.ncbi.nlm.nih.gov/pubmed/22393383$$D View this record in MEDLINE/PubMed
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2012 van der Helm et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.
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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.
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SSID ssj0053866
Score 2.2992423
Snippet In general, point-of-care (POC) tests for Chlamydia trachomatis (Ct) show disappointing test performance, especially disappointing sensitivity results....
Background In general, point-of-care (POC) tests for Chlamydia trachomatis (Ct) show disappointing test performance, especially disappointing sensitivity...
BACKGROUNDIn general, point-of-care (POC) tests for Chlamydia trachomatis (Ct) show disappointing test performance, especially disappointing sensitivity...
BackgroundIn general, point-of-care (POC) tests for Chlamydia trachomatis (Ct) show disappointing test performance, especially disappointing sensitivity...
Background In general, point-of-care (POC) tests for Chlamydia trachomatis (Ct) show disappointing test performance, especially disappointing sensitivity...
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StartPage e32122
SubjectTerms 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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Title Point-of-care test for detection of urogenital chlamydia in women shows low sensitivity. A performance evaluation study in two clinics in Suriname
URI https://www.ncbi.nlm.nih.gov/pubmed/22393383
https://www.proquest.com/docview/1333199628
https://search.proquest.com/docview/926644717
https://pubmed.ncbi.nlm.nih.gov/PMC3290553
https://doaj.org/article/3c4744da7110415f8269c9d4c05c18c9
http://dx.doi.org/10.1371/journal.pone.0032122
Volume 7
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