Limited diagnostic value of two commercial rapid tests for acute leptospirosis detection in Malaysia

Chang, Chiat Han; Riazi, Mehdi; Yunus, Muhammad Hafiznur; Osman, Sabariah; Noordin, Rahmah

doi:10.1016/j.diagmicrobio.2014.08.012

Cited by 12 publications

(13 citation statements)

References 23 publications

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“…Insufficient data was available to provide effective comparison between the RDT and validated MAT results; the study of paired acute and convalescent sera samples would provide more conclusive MAT results and allow for better assessment of the antibody detection accuracy of the Leptorapide RDT. Nevertheless, the present results are consistent with other studies carried out in Southeast Asia [ 21 , 22 ] which have likewise shown that sensitivity and specificity of RDTs for Leptospira infections are often low when compared to PCR.…”

Section: Discussionsupporting

confidence: 93%

Leptospirosis infections among hospital patients, Sarawak, Malaysia

Hii

Robie

Saihidi

et al. 2021

Trop Dis Travel Med Vaccines

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Background Leptospirosis diagnoses have increased in Sarawak, Malaysia in recent years. Methods To better understand the burden of disease and associated risk factors, we evaluated 147 patients presenting with clinical leptospirosis to local hospitals in Sarawak, Malaysia for the presence of Leptospira and associated antibodies. Sera and urine specimens collected during the acute illness phase were assessed via a commercially available rapid diagnostic test (Leptorapide, Linnodee Ltd., Antrim, Northern Ireland), an ELISA IgM assay (Leptospira IgM ELISA, PanBio, Queensland, Australia) and a pan-Leptospira real-time PCR (qPCR) assay to estimate disease prevalence and diagnostic accuracy of each method. Microagglutination testing was performed on a subset of samples. Results Overall, 45 out of 147 patients (30.6%) showed evidence of leptospires through qPCR in either one or both sera (20 patients) or urine (33 patients), and an additional ten (6.8%) were considered positive through serological testing, for an overall prevalence of 37.4% within the study population. However, each diagnostic method individually yielded disparate prevalence estimates: rapid test 42.2% for sera and 30.5% for urine, ELISA 15.0% for sera, qPCR 13.8% for sera and 23.4% for urine. Molecular characterization of a subset of positive samples by conventional PCR identified the bacterial species as Leptospira interrogans in 4 specimens. A multivariate risk factor analysis for the outcome of leptospirosis identified having completed primary school (OR = 2.5; 95 CI% 1.0–6.4) and weekly clothes-washing in local rivers (OR = 10.6; 95 CI% 1.4–214.8) with increased likelihood of leptospirosis when compared with those who had not. Conclusion Overall, the data suggest a relatively high prevalence of leptospirosis in the study population. The low sensitivities of the rapid diagnostic test and ELISA assay against qPCR highlight a need for better screening tools.

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Section: Discussionsupporting

confidence: 93%

Leptospirosis infections among hospital patients, Sarawak, Malaysia

Hii

Robie

Saihidi

et al. 2021

Trop Dis Travel Med Vaccines

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“…Twelve studies employed a cross-sectional design [ 23 , 24 , 25 , 26 , 29 , 30 , 31 , 35 , 36 , 38 , 39 , 41 ], eight are case-control studies [ 28 , 32 , 33 , 34 , 40 , 42 , 43 , 44 ], and two studies are experimental [ 16 , 37 ]. Evaluations were performed among participants from Laos [ 23 , 38 ], Thailand [ 16 , 24 , 33 , 39 , 42 ], Sri Lanka [ 25 , 31 , 36 ], Malaysia [ 26 , 28 , 32 , 34 ], Slovenia [ 29 ], United States [ 30 , 33 , 39 , 40 ], Palau [ 33 ], India [ 35 , 37 , 39 , 43 , 44 ], Barbados [ 39 ], Kenya [ 39 ], New Zealand [ 39 ], Philippines [ 39 ], Puerto Rico [ 39 ], Suriname [ 39 ], The Netherlands [ 39 , 40 , 41 ], Russia [ 39 ], Seychelles [ 39 ], and Indonesia [ 40 ]. The sample matrix used in the studies for the ICT kits was serum and was collected in the first to second week after the onset of fever.…”

Section: Resultsmentioning

confidence: 99%

Evaluating immunochromatographic test kits for diagnosis of acute human leptospirosis: A systematic review

Clemente

Pineda-Cortel²,

Villaflores³

2022

Heliyon

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“…The results shown that the ELISA has a better level of performance as compared to previously evaluated Leptospirosis rapid test that available in Malaysia [5]. The sensitivity is minimally improved with the addition of interpretation for 'intermediate' as positive.…”

Section: Discussionmentioning

confidence: 91%

“…Although MAT is the gold standard diagnostic tool for leptospirosis the result will take at least two days and this test is only available in specialized diagnostic centre because of certain technical expertise requirement. A reliable and faster screening test should be available to help physician to differentiate leptospirosis from other cause of acute febrile illness [5].…”

Section: Discussionmentioning

confidence: 99%

“…Leptospirosis remained endemic in Malaysia and increased numbers of cases are observed from 2012-2013 with total fatality rate of 1.47% [4]. The current rapid tests for leptospirosis available in Malaysia have low diagnostic sensitivity so there is a need to have a diagnostic kit that are both specific and sensitive [5]. The gold standard test which is MAT requires maintenance of a large panel of live Leptospira stock cultures, laboratory technical expertise [6] and are only available in certain diagnostic centres such as Institute for Medical Research (IMR), Kuala Lumpur [1].…”

Section: Introductionmentioning

confidence: 99%

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Evaluation of a Commercial Enzyme-Linked Immunosorbent Assay Kit for Detection of IgM Antibody against Leptospira in Human Sera for Patients admitted in Malaysian Hospitals

Esa¹,

Amran²,

Halim³

2018

Clin Microbiol

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Leptospirosis is an infectious zoonotic disease caused by corkscrew shaped of pathogenic Leptospira spp. Early diagnosis is important as the disease can be treated with antibiotic to prevent complications. The gold standard of leptospirosis diagnosis is microscopic agglutination test (MAT). However, the test is laborious and time consuming. This study aimed to evaluate whether a commercial ELISA (enzyme-linked immunosorbent assay) kit by Virion-Serion can demonstrate antibody against leptospires for accurate and rapid screening for leptospirosis. A total of 212 serum samples were tested with Virion-Serion Classic ELISA IgM, which was earlier collected from patient with clinical manifestation suggestive of leptospirosis in Malaysia and confirmed with MAT. The results were analyzed into two categories. In the first category all samples that were positive with MAT but detected as intermediate by the ELISA were not included. In the second category, all sample that positive with MAT but detected as intermediate were included. When the intermediate results were excluded, the clinical sensitivity was 73% and clinical specificity was 94%. When the intermediate results were included, the clinical sensitivity and specificity were 75% and 85% respectively. From this finding we can conclude that Virion-Serion ELISA IgM Classic kit have a reasonably appropriate performance and can be used for screening and diagnosis for leptospirosis in acute febrile illness however it should be confirmed later with the gold standard serological test which is MAT.

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Limited diagnostic value of two commercial rapid tests for acute leptospirosis detection in Malaysia

Cited by 12 publications

References 23 publications

Leptospirosis infections among hospital patients, Sarawak, Malaysia

Leptospirosis infections among hospital patients, Sarawak, Malaysia

Evaluating immunochromatographic test kits for diagnosis of acute human leptospirosis: A systematic review

Evaluation of a Commercial Enzyme-Linked Immunosorbent Assay Kit for Detection of IgM Antibody against Leptospira in Human Sera for Patients admitted in Malaysian Hospitals

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