Dataset Information

A prospective study to evaluate the accuracy of rapid diagnostic tests for diagnosis of human leptospirosis: Result from THAI-LEPTO AKI study.

ABSTRACT:

Background

Rapid diagnostic tests (RDTs) have become widely used in low-resource settings for leptospirosis diagnostic. This study aims to evaluate the diagnostic performance of the five commercially available RDTs to detect human IgM against Leptospira spp. in Thai population.

Methodology/principal findings

Ninety-nine serum samples from Leptospirosis suspicious patients were tested with five RDTs, including Medical Science Public Health, Leptocheck-WB, SD bioline, TRUSTline, and J.Mitra. The case definition was based on MAT, qPCR, and culture results. Diagnostic accuracy was determined based on the first day of enrollment in an overall analysis and stratified according to days post-onset of fever. The five RDTs had overall sensitivity ranging from 1.8% to 75% and specificity ranging from 52.3% to 97.7%. Leptocheck-WB had high sensitivity of 75.0%. The sensitivity of five RDTs increased on days 4-6 post-onset of fever, while the specificity of all tests remained relatively stable at different days post-onset of fever.

Conclusions/significance

The tested RDTs showed low sensitivity. Therefore, based on the present study, five commercially available RDTs might not be an appropriate test for acute leptospirosis screening in the Thai population.

SUBMITTER: Dinhuzen J

PROVIDER: S-EPMC7894855 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

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Publications

A prospective study to evaluate the accuracy of rapid diagnostic tests for diagnosis of human leptospirosis: Result from THAI-LEPTO AKI study.

Dinhuzen Janejira J Limothai Umaporn U Tachaboon Sasipha S Krairojananan Panadda P Laosatiankit Bangon B Boonprasong Sakarin S Lumlertgul Nuttha N Peerapornratana Sadudee S Srisawat Nattachai N

PLoS neglected tropical diseases 20210219 2

<h4>Background</h4>Rapid diagnostic tests (RDTs) have become widely used in low-resource settings for leptospirosis diagnostic. This study aims to evaluate the diagnostic performance of the five commercially available RDTs to detect human IgM against Leptospira spp. in Thai population.<h4>Methodology/principal findings</h4>Ninety-nine serum samples from Leptospirosis suspicious patients were tested with five RDTs, including Medical Science Public Health, Leptocheck-WB, SD bioline, TRUSTline, and ...[more]

PMID: 33606698

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Project description:Leptospirosis is one of the most important zoonosis in the tropics. Currently, specific laboratory diagnostic test for leptospirosis such as polymerase chain reaction (PCR) or direct culture cannot be applied at the primary care setting especially in the resource- limited countries. Therefore, clinical presentation and laboratory examination are still the primary diagnostic tools for leptospirosis.To detect clinical factors for predicting leptospirosis in suspected cases, and to create a clinical prediction score (THAI-LEPTO) that is practical and easy to use in general practice while awaiting laboratory results.We performed a prospective multicenter study with a development and a validation cohort of patients presenting with clinical suspicion of leptospirosis as per the WHO clinical criteria. The development cohort was conducted at 11 centers in 8 provinces around Thailand. The validation cohort was conducted at 4 centers in 1 province from the Northeastern part of Thailand. Leptospirosis confirmed cases were defined if any one of the tests were positive: microscopic agglutination test, direct culture, or PCR technique. Multivariable logistic regression was used to identify predictors of leptospirosis. The clinical prediction score was derived from the regression coefficients (original) or from the odds ratio values (simplified). We used receiver operating characteristic (ROC) curve analysis to evaluate the diagnostic ability of our score and to find the optimal cutoff values of the score. We used a validation cohort to evaluate the accuracy of our methods.In the development cohort, we enrolled 221 leptospirosis suspected cases and analyzed 211. Among those, 105 (50%) were leptospirosis confirmed cases. In logistic regression adjusted for age, gender, day of fever, and one clinical factor at a time, leptospirosis group had more hypotension OR = 2.76 (95% CI 1.07-7.10), jaundice OR = 3.40 (95%CI 1.48-8.44), muscle pain OR = 2.12 (95%CI 1.06-4.26), acute kidney injury (AKI) OR = 2.90 (95%CI 1.31-6.15), low hemoglobin OR = 3.48 (95%CI 1.72-7.04), and hypokalemia with hyponatremia OR = 3.56 (95%CI 1.17-10.84) than non-leptospirosis group. The abovementioned factors along with neutrophilia and pulmonary opacity were used in the development of the score. The simplified score with 7 variables was the summation of the odds ratio values as follows: hypotension 3, jaundice 2, muscle pain 2, AKI 1.5, low hemoglobin 3, hypokalemia with hyponatremia 3, and neutrophilia 1. The score showed the highest discriminatory power with area under the curve (AUC) 0.82 (95%CI 0.67-0.97) on fever day 3-4. In the validation cohort we enrolled 96 leptospirosis suspected cases and analyzed 92. Of those, 69 (75%) were leptospirosis confirmed cases. The performance of the simplified score with 7 variables at a cutoff of 4 was AUC 0.78 (95%CI 0.68-0.89); sensitivity 73.5; specificity 73.7; positive predictive value 87.8; negative predictive value 58.3.THAI-LEPTO score is a newly developed diagnostic tool for early presumptive diagnosis of leptospirosis in patients presenting with severe clinical suspicion of the disease. The score can easily be applied at the point of care while awaiting confirmatory laboratory results. Each predictor used has been supported by evidence of clinical and pathophysiological correlation.

Project description:BACKGROUND:Dengue is an emerging infectious disease that infects up to 390 million people yearly. The growing demand of dengue diagnostics especially in low-resource settings gave rise to many rapid diagnostic tests (RDT). This study evaluated the accuracy and utility of ViroTrack Dengue Acute - a new biosensors-based dengue NS1 RDT, SD Bioline Dengue Duo NS1/IgM/IgG combo - a commercially available RDT, and SD Dengue NS1 Ag enzyme-linked immunosorbent assay (ELISA), for the diagnosis of acute dengue infection. METHODS:This prospective cross-sectional study consecutively recruited 494 patients with suspected dengue from a health clinic in Malaysia. Both RDTs were performed onsite. The evaluated ELISA and reference tests were performed in a virology laboratory. The reference tests comprised of a reverse transcription-polymerase chain reaction and three ELISAs for the detection of dengue NS1 antigen, IgM and IgG antibodies, respectively. The diagnostic performance of evaluated tests was computed using STATA version 12. RESULTS:The sensitivity and specificity of ViroTrack were 62.3% (95%CI 55.6-68.7) and 95.0% (95%CI 91.7-97.3), versus 66.5% (95%CI 60.0-72.6) and 95.4% (95%CI 92.1-97.6) for SD NS1 ELISA, and 52.4% (95%CI 45.7-59.1) and 97.7% (95%CI 95.1-99.2) for NS1 component of SD Bioline, respectively. The combination of the latter with its IgM and IgG components were able to increase test sensitivity to 82.4% (95%CI 76.8-87.1) with corresponding decrease in specificity to 87.4% (95%CI 82.8-91.2). Although a positive test on any of the NS1 assays would increase the probability of dengue to above 90% in a patient, a negative result would only reduce this probability to 23.0-29.3%. In contrast, this probability of false negative diagnosis would be further reduced to 14.7% (95%CI 11.4-18.6) if SD Bioline NS1/IgM/IgG combo was negative. CONCLUSIONS:The performance of ViroTrack Dengue Acute was comparable to SD Dengue NS1 Ag ELISA. Addition of serology components to SD Bioline Dengue Duo significantly improved its sensitivity and reduced its false negative rate such that it missed the fewest dengue patients, making it a better point-of-care diagnostic tool. New RDT like ViroTrack Dengue Acute may be a potential alternative to existing RDT if its combination with serology components is proven better in future studies.

Project description:BackgroundLeptospirosis is an important but largely under-recognized public health problem in the tropics. Establishment of highly sensitive and specific laboratory diagnosis is essential to reveal the magnitude of problem and to improve treatment. This study aimed to evaluate the diagnostic accuracy of a recombinant LigA protein based IgM ELISA during outbreaks in the clinical-setting of a highly endemic country.Methodology/principal findingsA prospective study was conducted from October 2011 to September 2013 at a national referral hospital for infectious diseases in Manila, Philippines. Patients who were hospitalized with clinically suspected leptospirosis were enrolled. Plasma and urine were collected on admission and/or at discharge and tested using the LigA-IgM ELISA and a whole cell-based IgM ELISA. Sensitivity and specificity of these tests were evaluated with cases diagnosed by microscopic agglutination test (MAT), culture and LAMP as the composite reference standard and blood bank donors as healthy controls: the mean+3 standard deviation optical density value of healthy controls was used as the cut-off limit (0.062 for the LigA-IgM ELISA and 0.691 for the whole cell-based IgM ELISA). Of 304 patients enrolled in the study, 270 (89.1%) were male and the median age was 30.5 years; 167 (54.9%) were laboratory confirmed. The sensitivity and ROC curve AUC for the LigA-IgM ELISA was significantly greater than the whole cell-based IgM ELISA (69.5% vs. 54.3%, p<0.01; 0.90 vs. 0.82, p<0.01) on admission, but not at discharge. The specificity of LigA-IgM ELISA and whole cell-based IgM ELISA were not significantly different (98% vs. 97%). Among 158 MAT negative patients, 53 and 28 were positive by LigA- and whole cell-based IgM ELISA, respectively; if the laboratory confirmation was re-defined by LigA-IgM ELISA and LAMP, the clinical findings were more characteristic of leptospirosis than the diagnosis based on MAT/culture/LAMP.Conclusions/significanceThe newly developed LigA-IgM ELISA is more sensitive than the whole cell-based IgM based ELISA. Although the final diagnosis must be validated by more specific tests, LigA-IgM ELISA could be a useful diagnostic test in a real clinical-setting, where diagnosis is needed in the early phase of infection.

Project description:Overall accuracy measures of medical tests are often used with unclear interpretations. To develop methods of calculating the overall accuracy of medical tests in the patient population. Algebraic equations based on Bayes' theorem. A new approach is proposed for calculating overall accuracy in the patient population. Examples and applications using published data are presented. The overall accuracy is the proportion of the correct test results. We introduce a clear distinction between the overall accuracy measures of medical tests that are aimed at the detection of a disease in a screening of populations for public health purposes in the general population and the overall accuracy measures of tests aimed at determining a diagnosis in individuals in a clinical setting. We show that the overall detection accuracy measure is obtained in a specific study that explores test accuracy among persons with known diagnoses and may be useful for public health screening tests. It is different from the overall diagnostic accuracy that could be calculated in the clinical setting for the evaluation of medical tests aimed at determining the individual patients' diagnoses. We show that the overall detection accuracy is constant and is not affected by the prevalence of the disease. In contrast, the overall diagnostic accuracy changes and is dependent on the prevalence. Moreover, it ranges according to the ratio between the sensitivity and specificity. Thus, when the sensitivity is greater than the specificity, the overall diagnostic accuracy increases with increasing prevalence, and vice versa, that is, when the sensitivity is lower than the specificity, the overall diagnostic accuracy decreases with increasing prevalence so that another test might be more useful for diagnostic procedures. Our paper suggests a new and more appropriate methodology for estimating the overall diagnostic accuracy of any medical test. This may be important for helping clinicians avoid errors.

Dataset Information

A prospective study to evaluate the accuracy of rapid diagnostic tests for diagnosis of human leptospirosis: Result from THAI-LEPTO AKI study.

Background

Methodology/principal findings

Conclusions/significance

Publications

A prospective study to evaluate the accuracy of rapid diagnostic tests for diagnosis of human leptospirosis: Result from THAI-LEPTO AKI study.

Similar Datasets

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