TY - JOUR
T1 - Evaluation of a rapid diagnostic test for measles IgM detection; Accuracy and the reliability of visual reading using sera from the measles surveillance programme in Brazil, 2015
AU - Warrener, Lenesha
AU - Andrews, Nick
AU - Koroma, Halima
AU - Alessandrini, Isabella
AU - Haque, Mahmoud
AU - Garcia, Cristiana C.
AU - Matos, Aline R.
AU - Caetano, Braulia
AU - Lemos, Xenia R.
AU - Siqueira, Marilda M.
AU - Samuel, Dhanraj
AU - Brown, David W.
N1 - Publisher Copyright:
© Crown - UK Health Security Agency, 2023. Published by Cambridge University Press.
PY - 2023/8/4
Y1 - 2023/8/4
N2 - Laboratory-based case confirmation is an integral part of measles surveillance programmes; however, logistical constraints can delay response. Use of RDTs during initial patient contact could enhance surveillance by real-time case confirmation and accelerating public health response. Here, we evaluate performance of a novel measles IgM RDT and assess accuracy of visual interpretation using a representative collection of 125 sera from the Brazilian measles surveillance programme. RDT results were interpreted visually by a panel of six independent observers, the consensus of three observers and by relative reflectance measurements using an ESEQuant Reader. Compared to the Siemens anti-measles IgM EIA, sensitivity and specificity of the RDT were 94.9% (74/78, 87.4-98.6%) and 95.7% (45/47, 85.5-99.5%) for consensus visual results, and 93.6% (73/78, 85.7-97.9%) and 95.7% (45/47, 85.5-99.5%), for ESEQuant measurement, respectively. Observer agreement, determined by comparison between individuals and visual consensus results, and between individuals and ESEQuant measurements, achieved average kappa scores of 0.97 and 0.93 respectively. The RDT has the sensitivity and specificity required of a field-based test for measles diagnosis, and high kappa scores indicate this can be accomplished accurately by visual interpretation alone. Detailed studies are needed to establish its role within the global measles control programme.
AB - Laboratory-based case confirmation is an integral part of measles surveillance programmes; however, logistical constraints can delay response. Use of RDTs during initial patient contact could enhance surveillance by real-time case confirmation and accelerating public health response. Here, we evaluate performance of a novel measles IgM RDT and assess accuracy of visual interpretation using a representative collection of 125 sera from the Brazilian measles surveillance programme. RDT results were interpreted visually by a panel of six independent observers, the consensus of three observers and by relative reflectance measurements using an ESEQuant Reader. Compared to the Siemens anti-measles IgM EIA, sensitivity and specificity of the RDT were 94.9% (74/78, 87.4-98.6%) and 95.7% (45/47, 85.5-99.5%) for consensus visual results, and 93.6% (73/78, 85.7-97.9%) and 95.7% (45/47, 85.5-99.5%), for ESEQuant measurement, respectively. Observer agreement, determined by comparison between individuals and visual consensus results, and between individuals and ESEQuant measurements, achieved average kappa scores of 0.97 and 0.93 respectively. The RDT has the sensitivity and specificity required of a field-based test for measles diagnosis, and high kappa scores indicate this can be accomplished accurately by visual interpretation alone. Detailed studies are needed to establish its role within the global measles control programme.
KW - ICT
KW - IgM
KW - RDT
KW - immunochromatographic test
KW - immunoglobulin M
KW - lateral flow
KW - measles
KW - rapid diagnostic test
KW - rubeola
KW - serology
KW - surveillance
KW - vaccine preventable disease
UR - http://www.scopus.com/inward/record.url?scp=85168164290&partnerID=8YFLogxK
U2 - 10.1017/S0950268823000845
DO - 10.1017/S0950268823000845
M3 - Article
C2 - 37539522
AN - SCOPUS:85168164290
SN - 0950-2688
VL - 151
JO - Epidemiology and Infection
JF - Epidemiology and Infection
M1 - e151
ER -