Accuracy of a Dual Path Platform (DPP) Assay for the Rapid Point-of-Care Diagnosis of Human Leptospirosis

Nabity, Scott A; Ribeiro, Guilherme S.; Aquino, Carolina Lessa; Takahashi, Daniele; Damião, Alcinéia Oliveira; Gonçalves, André H. O.; Miranda-Filho, Demócrito Barros; Greenwald, Rena; Esfandiari, Javan; Lyashchenko, Konstantin P.; Reis, Mitermayer Galvão dos; Medeiros, Marco Alberto; Ko, Albert Icksang

doi:10.1371/journal.pntd.0001878

Cited by 33 publications

(44 citation statements)

References 43 publications

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“…For Treponema pallidum antibody detection, the electronic reader with the default cutoff value of 10 had the best sensitivity and specificity. Our results are comparable to those of laboratory evaluations that were conducted previously with different point-of-care tests for HIV and treponemal antibody detection in sera and whole blood, which also yielded high performance values for sensitivity and specificity (1,(5)(6)(7)(11)(12)(13). In our evaluation, the sensitivity of the Chembio DPP HIV-syphilis rapid test to detect HIV antibodies was somewhat greater than its sensitivity to detect syphilis antibodies, in concurrence with several other studies (5,6,11,12,14).…”

supporting

confidence: 90%

Laboratory Evaluation of a Dual-Path Platform Assay for Rapid Point-of-Care HIV and Syphilis Testing

et al. 2016

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eWe assessed the laboratory performance of the Chembio dual-path platform HIV-syphilis rapid immunodiagnostic test and electronic reader for detection of HIV and Treponema pallidum antibodies in 450 previously characterized serum specimens. For visual or electronic reader HIV antibody detection, the sensitivity was 100% and the specificity was 98.7%. For visual T. pallidum antibody detection, the test sensitivity was 94.7% and the specificity was 100.0%; with the electronic reader, the sensitivity was 94.7% and the specificity was 99.7%. Rapid multiplex point-of-care tests are increasingly available means to screen for syphilis and HIV infections (1-4). Dual screening tests for antibodies to HIV and Treponema pallidum have been evaluated in serum and venipuncture whole-blood samples, showing excellent sensitivity and specificity (5-7). We assessed the laboratory performance of the Chembio dual-path platform (DPP) HIV-syphilis rapid test and the Chembio digital electronic reader with stored serum samples collected from a cohort of men who have sex with men (MSM) and transwomen at high risk for HIV and syphilis infections.Serum specimens were collected between 2013 and 2014 from MSM and transwomen who had been recruited into an ongoing cohort study in Lima, Peru, and the specimens were stored at Ϫ20°C (8). HIV positivity was determined with the Genscreen Ultra HIV Ag-Ab test (Bio-Rad, Hercules, CA), a novel enzyme immunoassay (EIA) which detects HIV p24 antigen (Ag) and HIV antibodies in the same test (9). Positive EIA results were confirmed by Western blotting (New Lav Blot I; Bio-Rad). Specimens also underwent rapid plasma reagin (RPR) testing, using the BD Macro-Vue RPR card test kit (BD, Franklin Lakes, NJ), and Treponema pallidum particle agglutination (TPPA) testing (Serodia; Fujirebio Diagnostics Inc., Tokyo, Japan). All tests were used according to the manufacturers' instructions.The Chembio DPP HIV-syphilis test is a single-use, visual and qualitative immunochromatographic, dual rapid test for the detection of antibodies to HIV types 1 and 2 and Treponema pallidum in human serum, plasma, or venous or fingerprick wholeblood samples (10). A red control line confirms test validity. Visual observation of a red line in the HIV and/or syphilis detection zone is interpreted as a reactive result (10).Immediately after visual interpretation, tests were analyzed using the small, battery-powered, Chembio electronic reader, which was designed specifically to complement the Chembio DPP technology. The electronic reader scans the DPP test cartridge and displays a numerical value based on the test line intensity. If the electronic reader value is higher than the set cutoff value, then the result for the sample is reported as positive; the test result is reported as negative if the measured value is lower than the cutoff value.We estimated the sensitivity, specificity, and 95% confidence intervals (CIs) using the exact binomial method, and we calculated the concordance between the visual results of the Chembio DPP HIV-sy...

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supporting

confidence: 90%

Laboratory Evaluation of a Dual-Path Platform Assay for Rapid Point-of-Care HIV and Syphilis Testing

et al. 2016

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“…Most state animal diagnostic laboratories in the United States use MAT for the serologic diagnosis of animal leptospirosis. Because of the serious drawbacks of the MAT assay, numerous attempts have been made to develop a serodiagnostic ELISA (10)(11)(12)(13)(14)(15)(16)(17)(18) or to develop a dual-path platform (DPP) assay (19). We previously used the LigACon protein for diagnosis of equine and canine leptospirosis (26,27).…”

Section: Discussionmentioning

confidence: 99%

“…Previously, several research groups have attempted to utilize different recombinant proteins from Leptospira spp. as antigens in an indirect enzyme-linked immunosorbent assay (ELISA) as a serodiagnostic test (10)(11)(12)(13)(14)(15)(16)(17)(18)(19). However, as far as we know, no one has applied them to equine leptospirosis diagnosis.…”

mentioning

confidence: 99%

Development of an Enzyme-Linked Immunosorbent Assay Using a Recombinant LigA Fragment Comprising Repeat Domains 4 to 7.5 as an Antigen for Diagnosis of Equine Leptospirosis

Yan

Saleem

McDonough

et al. 2013

Clin Vaccine Immunol

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Leptospira immunoglobulin (Ig)-like (Lig) proteins are a novel family of surface-associated proteins in which the N-terminal 630 amino acids are conserved. In this study, we truncated the LigA conserved region into 7 fragments comprising the 1st to 3rd (LigACon1-3), 4th to 7.5th (LigACon4-7.5), 4th (LigACon4), 4.5th to 5.5th (LigACon4.5-5.5), 5.5th to 6.5th (LigACon5.5-6.5), 4th to 5th (LigACon4-5), and 6th to 7.5th (LigACon6-7.5) repeat domains. All 7 recombinant Lig proteins were screened using a slot-shaped dot blot assay for the diagnosis of equine leptospirosis. Our results showed that LigACon4-7.5 is the best candidate diagnostic antigen in a slot-shaped dot blot assay. LigACon4-7.5 was further evaluated as an indirect enzyme-linked immunosorbent assay (ELISA) antigen for the detection of Leptospira antibodies in equine sera. This assay was evaluated with equine sera (n ‫؍‬ 60) that were microscopic agglutination test (MAT) negative and sera (n ‫؍‬ 220) that were MAT positive to the 5 serovars that most commonly cause equine leptospirosis. The indirect ELISA results showed that at a single serum dilution of 1:250, the sensitivity and specificity of ELISA were 80.0% and 87.2%, respectively, compared to those of MAT. In conclusion, an indirect ELISA was developed utilizing a recombinant LigA fragment comprising the 4th to 7.5th repeat domain (LigACon4-7.5) as a diagnostic antigen for equine leptospirosis. This ELISA was found to be sensitive and specific, and it yielded results that concurred with those of the standard MAT.

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“…18 Similarly, antigen-based detection methods such as the Dual Path Platform assay have been shown to be highly sensitive in the acute setting of severe disease and show promise for rapid detection in a broad range of healthcare settings. 19 Future clinical-based studies should evaluate the prospect of Leptospira spp. molecular testing as a first-line diagnostic tool to improve patient care and outcome, as delayed initiation of antibiotic treatment and hospital admission have been associated with increased mortality.…”

Section: Discussionmentioning

confidence: 99%

Fatal Leptospira spp./Zika Virus Coinfection—Puerto Rico, 2016

Neaterour

Rivera

Galloway

et al. 2017

The American Journal of Tropical Medicine and Hygiene

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Abstract.Coinfection with pathogens that cause acute febrile illness (AFI) can complicate patient diagnosis and management. This report describes a fatal case of Leptospira spp./Zika virus (ZIKV) coinfection in Puerto Rico. The patient presented with a 5-day history of AFI; reported behavioral risk factors for leptospirosis; was diagnosed with possible leptospirosis, dengue, chikungunya, or ZIKV disease; and received appropriate treatment for leptospirosis and dengue. Following a 3-day hospitalization, the patient died due to acute gastrointestinal hemorrhage, and kidney and liver failure. Serologic diagnostic testing for leptospirosis and ZIKV disease was negative; however, molecular diagnostic testing performed postmortem was positive for detection of Leptospira spp. and ZIKV nucleic acid. This case demonstrates the need for continued clinical awareness of leptospirosis in areas experiencing outbreaks of pathogens that cause AFI and the need for evaluation of coinfection with AFI-causing pathogens as a risk factor for increased severity of disease.

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Accuracy of a Dual Path Platform (DPP) Assay for the Rapid Point-of-Care Diagnosis of Human Leptospirosis

Cited by 33 publications

References 43 publications

Laboratory Evaluation of a Dual-Path Platform Assay for Rapid Point-of-Care HIV and Syphilis Testing

Laboratory Evaluation of a Dual-Path Platform Assay for Rapid Point-of-Care HIV and Syphilis Testing

Development of an Enzyme-Linked Immunosorbent Assay Using a Recombinant LigA Fragment Comprising Repeat Domains 4 to 7.5 as an Antigen for Diagnosis of Equine Leptospirosis

Fatal Leptospira spp./Zika Virus Coinfection—Puerto Rico, 2016

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