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Trop. Med. Infect. Dis. 2018, 3(3), 95; https://doi.org/10.3390/tropicalmed3030095

Diagnostic Accuracy of the InBios Scrub Typhus Detect™ ELISA for the Detection of IgM Antibodies in Chittagong, Bangladesh

1
Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, 420/6 Rajvithee Road, Bangkok 10400, Thailand
2
Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Old Road Campus, Roosevelt Drive, Oxford OX3 7FZ, UK
3
Chittagong Medical College Hospital, Chittagong, Bangladesh
4
Department of Medicine, Swiss Tropical and Public Health Institute, 4056 Basel, Switzerland
5
Faculty of Medicine, University of Basel, 4003 Basel, Switzerland
*
Author to whom correspondence should be addressed.
Received: 1 August 2018 / Revised: 20 August 2018 / Accepted: 27 August 2018 / Published: 1 September 2018
(This article belongs to the Special Issue The Past and Present Threat of Rickettsial Diseases)
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Abstract

Here we estimated the accuracy of the InBios Scrub Typhus Detect™ immunoglobulin M (IgM) ELISA to determine the optimal optical density (OD) cut-off values for the diagnosis of scrub typhus. Patients with undifferentiated febrile illness from Chittagong, Bangladesh, provided samples for reference testing using (i) qPCR using the Orientia spp. 47-kDa htra gene, (ii) IFA ≥1:3200 on admission, (iii) immunofluorescence assay (IFA) ≥1:3200 on admission or 4-fold rise to ≥3200, and (iv) combination of PCR and IFA positivity. For sero-epidemiological purposes (ELISA vs. IFA ≥1:3200 on admission or 4-fold rise to ≥3200), the OD cut-off for admission samples was ≥1.25, resulting in a sensitivity (Sn) of 91.5 (95% confidence interval (95% CI: 96.8–82.5) and a specificity (Sp) of 92.4 (95% CI: 95.0–89.0), while for convalescent samples the OD cut-off was ≥1.50 with Sn of 66.0 (95% CI: 78.5–51.7) and Sp of 96.0 (95% CI: 98.3–92.3). Comparisons against comparator reference tests (ELISA vs. all tests including PCR) indicated the most appropriate cut-off OD to be within the range of 0.75–1.25. For admission samples, the best Sn/Sp compromise was at 1.25 OD (Sn 91.5%, Sp 92.4%) and for convalescent samples at 0.75 OD (Sn 69.8%, Sp 89.5%). A relatively high (stringent) diagnostic cut-off value provides increased diagnostic accuracy with high sensitivity and specificity in the majority of cases, while lowering the cut-off runs the risk of false positivity. This study underlines the need for regional assessment of new diagnostic tests according to the level of endemicity of the disease given the high levels of residual or cross-reacting antibodies in the general population. View Full-Text
Keywords: scrub typhus; diagnosis; ELISA; Bangladesh scrub typhus; diagnosis; ELISA; Bangladesh
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Blacksell, S.D.; Kingston, H.W.F.; Tanganuchitcharnchai, A.; Phanichkrivalkosil, M.; Hossain, M.; Hossain, A.; Ghose, A.; Leopold, S.J.; Dondorp, A.M.; Day, N.P.J.; Paris, D.H. Diagnostic Accuracy of the InBios Scrub Typhus Detect™ ELISA for the Detection of IgM Antibodies in Chittagong, Bangladesh. Trop. Med. Infect. Dis. 2018, 3, 95.

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