Rapid Diagnostic Test

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Michael Marks - One of the best experts on this subject based on the ideXlab platform.

  • metaanalysis of the performance of a combined treponemal and nontreponemal Rapid Diagnostic Test for syphilis and yaws
    Clinical Infectious Diseases, 2016
    Co-Authors: Michael Marks, Yue Ping Yin, Xiang Sheng Chen, Arnold R Castro, Louise M Causer, Rebecca Guy, Regina Wangnapi
    Abstract:

    Background. The human treponematoses are important causes of disease. Mother-to-child transmission of syphilis remains a major cause of stillbirth and neonatal death. There are also almost 100 000 cases of endemic treponemal disease reported annually, predominantly yaws. Rapid Diagnostic Tests (RDTs) would improve access to screening for these diseases. Most RDTs cannot distinguish current and previous infection. The Dual Path Platform (DPP) Syphilis Screen & Confirm Test includes both a treponemal (T1) and nontreponemal (T2) component and may improve the accuracy of diagnosis. Methods. We conducted a metaanalysis of published and unpublished evaluations of the DPP-RDT for the diagnosis of syphilis and yaws. We calculated the sensitivity, specificity, and overall agreement of the Test compared with reference laboratory Tests. Results. Nine evaluations, including 7267 Tests, were included. Sensitivity was higher in patients with higher titer Rapid plasma reagin (≥1:16) for both the T1 (98.2% vs 90.1%, P < .0001) and the T2 component (98.2% vs 80.6%, P < .0001). Overall agreement between the DPP Test and reference serology was 85.2% (84.4%–86.1%). Agreement was highest for high-titer active infection and lowest for past infection. Conclusions. The RDT has good sensitivity and specificity of the treponemal and nontreponemal components both in cases of suspected syphilis and yaws, although the sensitivity is decreased at lower antibody titers.

  • evaluation of a Rapid Diagnostic Test for yaws infection in a community surveillance setting
    PLOS Neglected Tropical Diseases, 2014
    Co-Authors: Michael Marks, Adriana Goncalves, Ventis Vahi, Oliver Sokana, Elliot Puiahi, Zaixing Zhang, Tenneth Dalipanda, Christian Bottomley, David Mabey, Anthony W Solomon
    Abstract:

    Yaws is a non-venereal treponemal infection caused by Treponema pallidum ssp. pertenue. The WHO has launched a worldwide control programme, which aims to eradicate yaws by 2020. The development of a Rapid Diagnostic Test (RDT) for serological diagnosis in the isolated communities affected by yaws is a key requirement for the successful implementation of the WHO strategy. We conducted a study to evaluate the utility of the DPP Test in screening for yaws, utilizing samples collected as part of a community prevalence survey conducted in the Solomon Islands. 415 serum samples were Tested using both traditional syphilis serology (TPPA and quantitative RPR) and the Chembio DPP Syphilis Screen and Confirm RDT. We calculated the sensitivity and specificity of the RDT as compared to gold standard serology. The sensitivity of the RDT against TPPA was 58.5% and the specificity was 97.6%. The sensitivity of the RDT against RPR was 41.7% and the specificity was 95.2%. The sensitivity of the DPP was strongly related to the RPR titre with a sensitivity of 92.0% for an RPR titre of >1/16. Wider access to DPP Testing would improve our understanding of worldwide yaws case reporting and the Test may play a key role in assessing patients presenting with yaws like lesions in a post-mass drug administration (MDA) setting.

Michel Signoli - One of the best experts on this subject based on the ideXlab platform.

  • technical note a Rapid Diagnostic Test detects plague in ancient human remains an example of the interaction between archeological and biological approaches southeastern france 16th 18th centuries
    American Journal of Physical Anthropology, 2008
    Co-Authors: Raffaella Bianucci, Lila Rahalison, Alberto Peluso, Ezio Ferroglio, Emma Rabino Massa, Michel Signoli
    Abstract:

    A Rapid Diagnostic Test (RDT) that detects Yersinia pestis F1 antigen was applied to 28 putative plague victims exhumed from seven burial sites in southeastern France dating to the 16th–18th centuries. Yersinia pestis F1 antigen was detected in 19 of the 28 (67.9%) samples. The 27 samples used as negative controls yielded negative results. Soil samples taken from archeological sites related to both positive and negative samples Tested negative for F1 antigen. The detection threshold of the RDT for plague (0.5 ng/ml) is sufficient for a preliminary retrospective diagnosis of Y. pestis infection in human remains. The high specificity and sensitivity of the assay were confirmed. For two sites positive to F1 antigen (Lambesc and Marseille), Y. pestis-specific DNA (pla gene) had been identified previously by PCR-sequence based analyses. Specifically, the positive results for two samples, from the Lambesc cemetery and the Marseille pit burial, matched those previously reported using PCR. Independent analyses in Italy and France of different samples taken from the same burial sites (Draguignan and Martigues) led to the identification of both Y. pestis F1 antigen and Y. pestis pla and gplD genes. These data are clear evidence of the presence of Y. pestis in the ancient human remains examined in this study. Am J Phys Anthropol, 2008. © 2008 Wiley-Liss, Inc.

  • Technical Note: A Rapid Diagnostic Test Detects Plague in Ancient Human Remains : An Example of the Interaction Between Archeological and Biological Approaches (Southeastern France, 16th–18th Centuries)
    American Journal of Physical Anthropology, 2008
    Co-Authors: Raffaella Bianucci, Lila Rahalison, Emma Rabino-massa, Alberto Peluso, Ezio Ferroglio, Michel Signoli
    Abstract:

    A Rapid Diagnostic Test (RDT) that detects Yersinia pestis F1 antigen was applied to 28 putative plague victims exhumed from seven burial sites in southeastern France dating to the 16th–18th centuries. Yersinia pestis F1 antigen was detected in 19 of the 28 (67.9%) samples. The 27 samples used as negative controls yielded negative results. Soil samples taken from archeological sites related to both positive and negative samples Tested negative for F1 antigen. The detection threshold of the RDT for plague (0.5 ng/ml) is sufficient for a preliminary retrospective diagnosis of Y. pestis infection in human remains. The high specificity and sensitivity of the assay were confirmed. For two sites positive to F1 antigen (Lambesc and Marseille), Y. pestis specific DNA (pla gene) had been identified previously by PCR-sequence based analyses. Specifically, the positive results for two samples, from the Lambesc cemetery and the Marseille pit burial, matched those previously reported using PCR. Independent analyses in Italy and France of different samples taken from the same burial sites (Draguignan and Martigues) led to the identification of both Y. pestis F1 antigen and Y. pestis pla and gplD genes. These data are clear evidence of the presence of Y. pestis in the ancient human remains examined in this study.

Jan Jacobs - One of the best experts on this subject based on the ideXlab platform.

  • Diagnostic accuracy of the inbios amd Rapid Diagnostic Test for the detection of burkholderia pseudomallei antigen in grown blood culture broth
    European Journal of Clinical Microbiology & Infectious Diseases, 2018
    Co-Authors: M Peeters, Panha Chung, Kristien Mortelmans, Laura Maria Francisca Kuijpers, Syna Teav, Jan Jacobs
    Abstract:

    To assess the Diagnostic and operational performance of the InBiOS AMD Rapid Diagnostic Test (RDT) (Seattle, USA) for the detection of B. pseudomallei in grown blood culture broth. The InBiOS RDT is a lateral flow immunoassay in a strip format detecting B. pseudomallei capsular polysaccharide in culture fluids, marketed for research only. Broth of blood culture bottles (BacT/Alert, bioMerieux, Marcy L’Etoile, France) sampled in adult patients at the Sihanouk Hospital Center of HOPE, Phnom Penh, Cambodia, during 2010–2017 and stored at − 80 °C was Tested. They included samples grown with B. pseudomallei (n = 114), samples with no growth (n = 12), and samples with growth of other pathogens (n = 139, among which Burkholderia cepacia (n = 5)). Diagnostic sensitivity and specificity were 96.5% [95% confidence interval (CI): 91.3–98.6%] and 100% [CI: 97.5–100%] respectively. Background clearance and line intensities were good and very good. The RDT’s Test strip, not housed in a cassette, caused difficulties in manipulation and biosafety. The centrifugation step prescribed by the procedure challenged biosafety, but processing of 19 B. pseudomallei samples without centrifugation showed similar results for line intensity and background clearance, compared to centrifugation. The InBiOS RDT showed excellent accuracy for detection of B. pseudomallei in grown blood culture broth. Provided operational adaptations such as cassette housing, it has the potential to reduce time to diagnosis of melioidosis.

  • Evaluation of the malaria Rapid Diagnostic Test SDFK90: detection of both PfHRP2 and Pf-pLDH
    Malaria Journal, 2012
    Co-Authors: Marloes Heutmekers, Philippe Gillet, Lieselotte Cnops, Marjan Van Esbroeck, Emmanuel Bottieau, Jessica Maltha, Jan Jacobs
    Abstract:

    Background Rapid diagnosis of Plasmodium falciparum infections is important because of the potentially fatal complications. SDFK90 is a recently marketed malaria Rapid Diagnostic Test (RDT) targeting both histidine-rich protein 2 (PfHRP2) and P. falciparum-specific Plasmodium lactate dehydrogenase (Pf-pLDH). The present study evaluated its Diagnostic accuracy.

  • evaluation of the Rapid Diagnostic Test carestart pldh malaria pf pldh pan pldh for the diagnosis of malaria in a reference setting
    Malaria Journal, 2012
    Co-Authors: Marloes Heutmekers, Philippe Gillet, Lieselotte Cnops, Marjan Van Esbroeck, Emmanuel Bottieau, Jessica Maltha, Annelies Scheirlinck, Jan Jacobs
    Abstract:

    Background: The present study evaluated CareStart pLDH Malaria, a three-band Rapid Diagnostic Test detecting Plasmodium falciparum-specific parasite lactate dehydrogenase (Pf-pLDH) and pan Plasmodium-specific pLDH (pan-pLDH) in a reference setting. Methods: CareStart pLDH was retrospectively and prospectively assessed with a panel of stored (n=498) and fresh (n=77) blood samples obtained in international travelers suspected of malaria. Both panels comprised all four Plasmodium species; the retrospective panel comprised also Plasmodium negative samples. The reference method was microscopy corrected by PCR. The prospective panel was run side-to-side with OptiMAL (Pf-pLDH/pan-pLDH) and SDFK60 (histidine-rich protein-2 (HRP-2)/pan-pLDH). Results: In the retrospective evaluation, overall sensitivity for P. falciparum samples (n=247) was 94.7%, reaching 98.7% for parasite densities>1,000/μl. Most false negative results occurred among samples with pure gametocytaemia (2/12, 16.7%) and at parasite densities ≤100/μl (7/12, 58.3%). None of the Plasmodium negative samples (n=96) showed visible Test lines. Sensitivities for Plasmodium vivax (n=70), Plasmodium ovale (n=69) and Plasmodium malariae (n=16) were 74.3%, 31.9% and 25.0% respectively. Wrong species identification occurred in 10 (2.5%) samples and was mainly due to P. vivax samples reacting with the Pf-pLDH Test line. Overall, Pf-pLDH Test lines showed higher line intensities compared to the pan-pLDH lines (67.9% and 23.0% medium and strong line intensities for P. falciparum). In the prospective panel (77 Plasmodium-positive samples), CareStart pLDH showed higher sensitivities for P. falciparum compared to OptiMAL (p=0.008), lower sensitivities for P. falciparum as compare to SDFK60 (although not reaching statistical significance, p=0.08) and higher sensitivities for P. ovale compared to both OptiMAL (p=0.03) and SDFK60 (p=0.01). Inter-observer and Test reproducibility were good to excellent. Conclusion: CareStart pLDH performed excellent for the detection of P. falciparum, well for P. vivax, but poor for P. ovale and P. malariae.

  • Evaluation of the Immunoquick+4 malaria Rapid Diagnostic Test in a non-endemic setting
    European Journal of Clinical Microbiology and Infectious Diseases, 2010
    Co-Authors: D. P. J. Dijk, Philippe Gillet, Erika Vlieghe, Lieselotte Cnops, M. Esbroeck, Jan Jacobs
    Abstract:

    The aim of this retrospective study was to evaluate the Immunoquick+4 (BioSynex, Strasbourg, France), a three-band malaria Rapid Diagnostic Test (MRDT) targeting histidine-rich protein-2 (HRP-2) and pan -specific parasite lactate dehydrogenase, in a non-endemic reference setting. Stored whole-blood samples ( = 613) from international travellers suspected of malaria were used, with microscopy corrected by polymerase chain reaction (PCR) as the reference method. Samples infected by ( = 323), ( = 97), ( = 73) and ( = 25) were selected, as well as 95 malaria-negative samples. The overall sensitivities of the Immunoquick+4 for the diagnosis of , , and were 88.9, 75.3, 56.0 and 19.2%, respectively. Sensitivity was significantly related to parasite density for (93.6% versus 71.4% at parasite densities >100/µl and ≤100/µl, respectively) and (86.8% versus 48.3% at parasite densities >500/µl and ≤500/µl, respectively). The Immunoquick+4 showed good reproducibility and reliability for both Test results and line intensities. The Immunoquick+4 performed well for the detection of and .

  • Evaluation of the Palutop+4 malaria Rapid Diagnostic Test in a non-endemic setting.
    Malaria Journal, 2009
    Co-Authors: David P J Van Dijk, Philippe Gillet, Erika Vlieghe, Lieselotte Cnops, Marjan Van Esbroeck, Jan Jacobs
    Abstract:

    Background Palutop+4 (All. Diag, Strasbourg, France), a four-band malaria Rapid Diagnostic Test (malaria RDT) targeting the histidine-rich protein 2 (HRP-2), Plasmodium vivax- specific parasite lactate dehydrogenase (Pv-pLDH) and pan Plasmodium-specific pLDH (pan-pLDH) was evaluated in a non-endemic setting on stored whole blood samples from international travellers suspected of malaria.

Raffaella Bianucci - One of the best experts on this subject based on the ideXlab platform.

  • technical note a Rapid Diagnostic Test detects plague in ancient human remains an example of the interaction between archeological and biological approaches southeastern france 16th 18th centuries
    American Journal of Physical Anthropology, 2008
    Co-Authors: Raffaella Bianucci, Lila Rahalison, Alberto Peluso, Ezio Ferroglio, Emma Rabino Massa, Michel Signoli
    Abstract:

    A Rapid Diagnostic Test (RDT) that detects Yersinia pestis F1 antigen was applied to 28 putative plague victims exhumed from seven burial sites in southeastern France dating to the 16th–18th centuries. Yersinia pestis F1 antigen was detected in 19 of the 28 (67.9%) samples. The 27 samples used as negative controls yielded negative results. Soil samples taken from archeological sites related to both positive and negative samples Tested negative for F1 antigen. The detection threshold of the RDT for plague (0.5 ng/ml) is sufficient for a preliminary retrospective diagnosis of Y. pestis infection in human remains. The high specificity and sensitivity of the assay were confirmed. For two sites positive to F1 antigen (Lambesc and Marseille), Y. pestis-specific DNA (pla gene) had been identified previously by PCR-sequence based analyses. Specifically, the positive results for two samples, from the Lambesc cemetery and the Marseille pit burial, matched those previously reported using PCR. Independent analyses in Italy and France of different samples taken from the same burial sites (Draguignan and Martigues) led to the identification of both Y. pestis F1 antigen and Y. pestis pla and gplD genes. These data are clear evidence of the presence of Y. pestis in the ancient human remains examined in this study. Am J Phys Anthropol, 2008. © 2008 Wiley-Liss, Inc.

  • Technical Note: A Rapid Diagnostic Test Detects Plague in Ancient Human Remains : An Example of the Interaction Between Archeological and Biological Approaches (Southeastern France, 16th–18th Centuries)
    American Journal of Physical Anthropology, 2008
    Co-Authors: Raffaella Bianucci, Lila Rahalison, Emma Rabino-massa, Alberto Peluso, Ezio Ferroglio, Michel Signoli
    Abstract:

    A Rapid Diagnostic Test (RDT) that detects Yersinia pestis F1 antigen was applied to 28 putative plague victims exhumed from seven burial sites in southeastern France dating to the 16th–18th centuries. Yersinia pestis F1 antigen was detected in 19 of the 28 (67.9%) samples. The 27 samples used as negative controls yielded negative results. Soil samples taken from archeological sites related to both positive and negative samples Tested negative for F1 antigen. The detection threshold of the RDT for plague (0.5 ng/ml) is sufficient for a preliminary retrospective diagnosis of Y. pestis infection in human remains. The high specificity and sensitivity of the assay were confirmed. For two sites positive to F1 antigen (Lambesc and Marseille), Y. pestis specific DNA (pla gene) had been identified previously by PCR-sequence based analyses. Specifically, the positive results for two samples, from the Lambesc cemetery and the Marseille pit burial, matched those previously reported using PCR. Independent analyses in Italy and France of different samples taken from the same burial sites (Draguignan and Martigues) led to the identification of both Y. pestis F1 antigen and Y. pestis pla and gplD genes. These data are clear evidence of the presence of Y. pestis in the ancient human remains examined in this study.

Lila Rahalison - One of the best experts on this subject based on the ideXlab platform.

  • technical note a Rapid Diagnostic Test detects plague in ancient human remains an example of the interaction between archeological and biological approaches southeastern france 16th 18th centuries
    American Journal of Physical Anthropology, 2008
    Co-Authors: Raffaella Bianucci, Lila Rahalison, Alberto Peluso, Ezio Ferroglio, Emma Rabino Massa, Michel Signoli
    Abstract:

    A Rapid Diagnostic Test (RDT) that detects Yersinia pestis F1 antigen was applied to 28 putative plague victims exhumed from seven burial sites in southeastern France dating to the 16th–18th centuries. Yersinia pestis F1 antigen was detected in 19 of the 28 (67.9%) samples. The 27 samples used as negative controls yielded negative results. Soil samples taken from archeological sites related to both positive and negative samples Tested negative for F1 antigen. The detection threshold of the RDT for plague (0.5 ng/ml) is sufficient for a preliminary retrospective diagnosis of Y. pestis infection in human remains. The high specificity and sensitivity of the assay were confirmed. For two sites positive to F1 antigen (Lambesc and Marseille), Y. pestis-specific DNA (pla gene) had been identified previously by PCR-sequence based analyses. Specifically, the positive results for two samples, from the Lambesc cemetery and the Marseille pit burial, matched those previously reported using PCR. Independent analyses in Italy and France of different samples taken from the same burial sites (Draguignan and Martigues) led to the identification of both Y. pestis F1 antigen and Y. pestis pla and gplD genes. These data are clear evidence of the presence of Y. pestis in the ancient human remains examined in this study. Am J Phys Anthropol, 2008. © 2008 Wiley-Liss, Inc.

  • Technical Note: A Rapid Diagnostic Test Detects Plague in Ancient Human Remains : An Example of the Interaction Between Archeological and Biological Approaches (Southeastern France, 16th–18th Centuries)
    American Journal of Physical Anthropology, 2008
    Co-Authors: Raffaella Bianucci, Lila Rahalison, Emma Rabino-massa, Alberto Peluso, Ezio Ferroglio, Michel Signoli
    Abstract:

    A Rapid Diagnostic Test (RDT) that detects Yersinia pestis F1 antigen was applied to 28 putative plague victims exhumed from seven burial sites in southeastern France dating to the 16th–18th centuries. Yersinia pestis F1 antigen was detected in 19 of the 28 (67.9%) samples. The 27 samples used as negative controls yielded negative results. Soil samples taken from archeological sites related to both positive and negative samples Tested negative for F1 antigen. The detection threshold of the RDT for plague (0.5 ng/ml) is sufficient for a preliminary retrospective diagnosis of Y. pestis infection in human remains. The high specificity and sensitivity of the assay were confirmed. For two sites positive to F1 antigen (Lambesc and Marseille), Y. pestis specific DNA (pla gene) had been identified previously by PCR-sequence based analyses. Specifically, the positive results for two samples, from the Lambesc cemetery and the Marseille pit burial, matched those previously reported using PCR. Independent analyses in Italy and France of different samples taken from the same burial sites (Draguignan and Martigues) led to the identification of both Y. pestis F1 antigen and Y. pestis pla and gplD genes. These data are clear evidence of the presence of Y. pestis in the ancient human remains examined in this study.

  • development and Testing of a Rapid Diagnostic Test for bubonic and pneumonic plague
    The Lancet, 2003
    Co-Authors: S Chanteau, Lila Rahalison, Lalao Ralafiarisoa, Jeanine Foulon, M Ratsitorahina, Lala Ratsifasoamanana, Elisabeth Carniel, Farida Nato
    Abstract:

    Summary Background Plague is often fatal without prompt and appropriate treatment. It affects mainly poor and remote populations. Late diagnosis is one of the major causes of human death and spread of the disease, since it limits the effectiveness of control measures. We aimed to develop and assess a Rapid Diagnostic Test (RDT) for plague. Methods We developed a Test that used monoclonal antibodies to the F1 antigen of Yersinia pestis . Sensitivity and specificity were assessed with a range of bacterial cultures and clinical samples, and compared with findings from available ELISA and bacteriological Tests for plague. Samples from patients thought to have plague were Tested with the RDT in the laboratory and by health workers in 26 pilot sites in Madagascar. Findings The RDT detected concentrations of F1 antigen as low as 0·5 ng/mL in up to 15 min, and had a shelf life of 21 days at 60°C. Its sensitivity and specificity were both 100%. RDT detected 41·6% and 31% more positive clinical specimens than did bacteriological methods and ELISA, respectively. The agreement rate between Tests done at remote centres and in the laboratory was 89·8%. With the combination of bacteriological methods and F1 ELISA as reference standard, the positive and negative predictive values of the RDT were 90·6% and 86·7%, respectively. Interpretation Our RDT is a specific, sensitive, and reliable Test that can easily be done by health workers at the patient's bedside, for the Rapid diagnosis of pneumonic and bubonic plague. This Test will be of key importance for the control of plague in endemic countries.