Evaluation of diagnostic accuracy of the novel Scrub Typhus IgM ELISA Kit.

IF 1.8 4区医学 Q3 INFECTIOUS DISEASES

Diagnostic microbiology and infectious disease Pub Date : 2025-12-01 Epub Date: 2025-07-24 DOI:10.1016/j.diagmicrobio.2025.117025

Sangitha Jayagandan, Vimal Raj Ratchagadasse, Ferdinamarie Sharmila Philomenadin, Palanivel Chinnakali, Vivekanandan Pillai, Rahul Dhodapkar

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引用次数: 0

Abstract

Background: Scrub typhus (ST) is a rickettsial infection endemic in Southeast Asia, with diagnostic challenges due to its clinical overlap with other febrile illnesses. Due to its accessibility and ease of use, Enzyme-linked Immunosorbent Assay (ELISA) is the widely preferred diagnostic tool.

Objectives: This study aims to evaluate the diagnostic performance of the Scrub typhus IgM Microlisa kit (J. Mitra & Co Pvt., Ltd.,) for detecting ST IgM antibodies, using the Scrub Typhus Detect™ IgM ELISA (Inbios International, Inc.) as a reference standard.

Methods: A retrospective observational study was conducted using 547 serum samples archived between January 2022 and December 2023. Samples were tested for ST IgM antibodies using the J. Mitra Scrub typhus IgM Microlisa kit (index test) and the Inbios Scrub Typhus Detect™ IgM ELISA kit (reference standard). Sensitivity, specificity, diagnostic accuracy, and likelihood ratios were calculated with 95 % confidence intervals.

Results: Of the 247 seropositive samples demonstrated a sensitivity of 87.45 % (95 % CI: 82.74-91.02), specificity of 97.67 % (95 % CI: 95.26-98.87), and diagnostic accuracy of 93.05 % (95 % CI: 90.61-94.9) by index kit. The performance of the index kit was consistent across different durations of fever, with the highest sensitivity observed in samples from patients with a fever lasting >7 days.

Conclusions: The J. Mitra Scrub typhus IgM Microlisa kit demonstrates high sensitivity, specificity, and diagnostic accuracy, comparable with that of the reference standard. It offers a reliable alternative for the routine laboratory diagnosis of scrub typhus, facilitating timely diagnosis and management.

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新型恙虫病IgM酶联免疫吸附测定试剂盒诊断准确性评价。

背景：恙虫病（ST）是东南亚流行的一种立克次体感染，由于其临床与其他发热性疾病重叠，具有诊断挑战。由于其可及性和易用性，酶联免疫吸附试验（ELISA）是广泛首选的诊断工具。目的：本研究旨在评价恙虫病IgM Microlisa试剂盒（J. Mitra & Co Pvt., Ltd.）检测ST IgM抗体的诊断性能，使用恙虫病检测IgM ELISA （Inbios International, Inc.）作为参考标准。方法：对2022年1月至2023年12月间存档的547份血清样本进行回顾性观察研究。使用J. Mitra Scrub typhus IgM Microlisa试剂盒（指数检测）和Inbios Scrub typhus Detect™IgM ELISA试剂盒（参比标准）检测样品的ST IgM抗体。敏感性、特异性、诊断准确性和似然比以95%的置信区间计算。结果：247份血清阳性标本中，指标试剂盒的敏感性为87.45% (95% CI: 82.74 ~ 91.02)，特异性为97.67% (95% CI: 95.26 ~ 98.87)，诊断准确率为93.05% （95% CI: 90.61 ~ 94.9）。指数试剂盒的性能在不同的发烧持续时间是一致的，在发烧持续50至70天的患者的样本中观察到最高的灵敏度。结论：J. Mitra恙虫病IgM Microlisa试剂盒具有较高的灵敏度、特异性和诊断准确性，与参比标准相当。为恙虫病常规实验室诊断提供了可靠的替代方法，便于及时诊断和管理。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Diagnostic microbiology and infectious disease 医学-传染病学

CiteScore

5.30

自引率

3.40%

发文量

149

审稿时长

56 days

期刊介绍： Diagnostic Microbiology and Infectious Disease keeps you informed of the latest developments in clinical microbiology and the diagnosis and treatment of infectious diseases. Packed with rigorously peer-reviewed articles and studies in bacteriology, immunology, immunoserology, infectious diseases, mycology, parasitology, and virology, the journal examines new procedures, unusual cases, controversial issues, and important new literature. Diagnostic Microbiology and Infectious Disease distinguished independent editorial board, consisting of experts from many medical specialties, ensures you extensive and authoritative coverage.