Comparative evaluation of assays for IgM detection of rubella and measles infections

Olmeda, Mayte Pérez; Balfagón, Pilar; Camacho, Juan Pedro M.; Dafouz, Desirée; Fuente, Jesús de la; Murillo, María Ángeles; Muñoz, José Luis Pedraz; García, Aurora Fernández; Sanz, Juan Carlos; Ory, Fernando de

doi:10.1016/j.eimce.2020.06.020

Cited by 2 publications

(2 citation statements)

References 17 publications

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“…The primary analysis of RDT performance was based on the current reference standard used by surveillance programs, a positive measles IgM EIA result or RT-qPCR result. The Virion/Serion assay, an indirect assay used for comparison in this study, has a sensitivity of 98% and a specificity of 88% [ 13 , 14 ], which is sufficiently accurate to detect chains of transmission as required for surveillance but insufficiently accurate on its own to define true cases for such an evaluation, especially where most specimens (79%) are collected within 3 days of rash onset when EIA sensitivity is lower. In elimination settings, RT-qPCR testing is increasingly relied upon to aid measles case classification because a positive result is definitive, and RT-qPCR can detect measles RNA in specimens taken in the first several days after rash onset.…”

Section: Discussionmentioning

confidence: 99%

A measles IgM rapid diagnostic test to address challenges with national measles surveillance and response in Malaysia

Senin,

Noordin,

Sani

et al. 2024

PLoS ONE

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Introduction A lateral flow rapid diagnostic test (RDT) enables detection of measles specific immunoglobulin M (IgM) antibody in serum, capillary blood, and oral fluid with accuracy consistent with enzyme immunoassay (EIA). The objectives of the study were: 1) to assess measles RDT inter-reader agreement between two clinic staff; 2) to assess the sensitivity and specificity of the measles RDT relative to standard surveillance testing in a low transmission setting; 3) to evaluate the knowledge, attitudes, and practices of staff in clinics using the RDT; and 4) to assess the impact of RDT testing on the measles public health response in Malaysia. Materials and methods The clinic-based prospective evaluation included all suspected measles cases captured by routine measles surveillance at 34 purposely selected clinics in 15 health districts in Malaysia between September 2019 and June 2020, following day-long regional trainings on RDT use. Following informed consent, four specimens were collected from each suspected case, including those routinely collected for standard surveillance [serum for EIA and throat swabs for quantitative reverse transcriptase polymerase chain reaction (RT-qPCR)] together with capillary blood and oral fluid tested with RDTs during the study. RDT impact was evaluated by comparing the rapidity of measles public health response between the pre-RDT implementation (December 2018 to August 2019) and RDT implementation periods (September 2019 to June 2020). To assess knowledge, attitudes, and practices of RDT use, staff involved in the public health management of measles at the selected sites were surveyed. Results Among the 436 suspect cases, agreement of direct visual readings of measles RDT devices between two health clinic staff was 99% for capillary blood (k = 0.94) and 97% for oral fluid (k = 0.90) specimens. Of the total, 45 (10%) were positive by measles IgM EIA (n = 44, including five also positive by RT-qPCR) or RT-qPCR only (n = 1), and 38 were positive by RDT (using either capillary blood or oral fluid). Using measles IgM EIA or RT-qPCR as reference, RDT sensitivity using capillary blood was 43% (95% CI: 30%–58%) and specificity was 98% (95% CI: 96%–99%); using oral fluid, sensitivity (26%, 95% CI: 15%–40%) and specificity (97%, 95% CI: 94%–98%) were lower. Nine months after training, RDT knowledge was high among staff involved with the public health management of measles (average quiz score of 80%) and was highest among those who received formal training (88%), followed by those trained during supervisory visits (83%). During the RDT implementation period, the number of days from case confirmation until initiation of public response decreased by about 5 days. Conclusion The measles IgM RDT shows >95% inter-reader agreement, high retention of RDT knowledge, and a more rapid public health response. However, despite ≥95% RDT specificity using capillary blood or oral fluid, RDT sensitivity was <45%. Higher-powered studies using highly specific IgM assays and systematic RT-qPCR for case confirmation are needed to establish the role of RDT in measles elimination settings.

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Section: Discussionmentioning

confidence: 99%

A measles IgM rapid diagnostic test to address challenges with national measles surveillance and response in Malaysia

Senin,

Noordin,

Sani

et al. 2024

PLoS ONE

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“…A few studies ( 12 – 16 ) in our analysis contained data for the discontinued Siemens Enzygnost kits. For reader’s interest, we have included these forest plots in the supplementary data showing how the Siemens Enzygnost kits performed compared to the other index tests (Fig.…”

Section: Methodsmentioning

confidence: 99%

Diagnostic accuracy of commercially available serological tests for the detection of measles and rubella viruses: a systematic review and meta-analysis

Zubach,

Beirnes,

Hayes

et al. 2024

J Clin Microbiol

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Measles and rubella serological diagnoses are done by IgM detection. The World Health Organization Global Measles and Rubella Laboratory Network previously endorsed Siemens Enzygnost enzyme-linked immunosorbant assay kits, which have been discontinued. A recommended replacement has not been determined. We aimed to search for suitable replacements by conducting a systematic review and meta-analysis of IgM detection methods that are currently available for measles and rubella. A systematic literature search was performed in Medline, Embase, Global Health, Cochrane Central, and Scopus on March 22 and on 27 September 2023. Studies reporting measles and/or rubella IgM detection with terms around diagnostic accuracy were included. Risk of bias was assessed using QUADAS tools. Meta-DiSc and R were used for statistical analysis. Clinical samples totalling 5,579 from 28 index tests were included in the measles meta-analysis. Sensitivity and specificity of the individual measles studies ranged from 0.50 to 1.00 and 0.53 to 1.00, respectively. Pooled sensitivity and specificity of all measles IgM detection methods were 0.94 (CI: 0.90–0.97) and 0.94 (CI: 0.91–0.97), respectively. Clinical samples totalling 4,983 from 15 index tests were included in the rubella meta-analysis. Sensitivity and specificity of the individual rubella studies ranged from 0.78 to 1.00 and 0.52 to 1.00, respectively. Pooled sensitivity and specificity of all rubella IgM detection methods were 0.97 (CI: 0.93–0.98) and 0.96 (CI: 0.93–0.98), respectively. Although more studies would be ideal, our results may provide valuable information when selecting IgM detection methods for measles and/or rubella.

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Comparative evaluation of assays for IgM detection of rubella and measles infections

Cited by 2 publications

References 17 publications

A measles IgM rapid diagnostic test to address challenges with national measles surveillance and response in Malaysia

A measles IgM rapid diagnostic test to address challenges with national measles surveillance and response in Malaysia

Diagnostic accuracy of commercially available serological tests for the detection of measles and rubella viruses: a systematic review and meta-analysis

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