Rapid diagnostic tests for plague

Abstract

BackgroundPlague is a severe disease associated with high mortality. Late diagnosis leads to advance stage of the disease with worse outcomes and higher risk of spread of the disease. A rapid diagnostic test (RDT) could help in establishing a prompt diagnosis of plague. This would improve patient care and help appropriate public health response. ObjectivesTo determine the diagnostic accuracy of the RDT based on the antigen F1 (F1RDT) for detecting plague in people with suspected disease. Search methodsWe searched the CENTRAL, Embase, Science Citation Index, Google Scholar, the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov up to 15 May 2019, and PubMed (MEDLINE) up to 27 August 2019, regardless of language, publication status, or publication date. We handsearched the reference lists of relevant papers and contacted researchers working in the field. Selection criteriaWe included cross-sectional studies that assessed the accuracy of the F1RDT for diagnosing plague, where participants were tested with both the F1RDT and at least one reference standard. The reference standards were bacterial isolation by culture, polymerase chain reaction (PCR), and paired serology (this is a four-fold di erence in F1 antibody titres between two samples from acute and convalescent phases). Data collection and analysisTwo review authors independently selected studies and extracted data. We appraised the methodological quality of each selected studies and applicability by using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool. When meta-analysis was appropriate, we used the bivariate model to obtain pooled estimates of sensitivity and specificity. We stratified all analyses by the reference standard used and presented disaggregated data for forms of plague. We assessed the certainty of the evidence using GRADE. Main resultsWe included eight manuscripts reporting seven studies. Studies were conducted in three countries in Africa among adults and children with any form of plague. All studies except one assessed the F1RDT produced at the Institut Pasteur of Madagascar (F1RDT-IPM) and one study assessed a F1RDT produced by New Horizons (F1RDT-NH), utilized by the US Centers for Disease Control and Prevention. We could not pool the findings from the F1RDT-NH in meta-analyses due to a lack of raw data and a threshold of the test for positivity di erent from the F1RDT-IPM.

An evaluation of computational methods for aggregate data meta-analyses of diagnostic test accuracy studies

“…In Illustrative examples section, we will demonstrate how the three computational algorithms deal with the data since the existence of such outlying studies may potentially distort the meta-analysis results. Zhao et al BMC Medical Research Methodology (2024) 24:111 In the second example, we present the study by Jullien et al (2020) that studied the diagnosing characteristics of "Rapid diagnostic tests for plague" [16]. As can be seen from the forest plots presented in Fig.…”

“…We present the results of fitting the BBN model to the meta-analysis of Jullien et al (2020) [16] in Table 4. The AGHQ algorithm failed to converge with its Hessian matrix being non-positive-definite.…”

Factors influencing the re-emergence of plague in Madagascar

“…It is important to note these tests are of differing utility in bubonic and pneumonic plague: the use of a molecular test less specific for pneumonic plague in the 2017 outbreak, which had an unusually high proportion of pneumonic cases, led to initial overestimates of confirmed plague cases before samples were retrospectively tested with a more specific but potentially less sensitive molecular test for pneumonic plague [21]. Notably, the F1 rapid diagnostic test which can be carried out at the bedside, negating some of the geographical issues above, has high sensitivity but does not give the same information on Y. pestis strain or antibiotic resistance as bacterial culture [56].…”

Isolation of camel single domain antibodies against Yersinia pestis V270 antigen based on a semi‐synthetic single domain antibody library and development of a VHH‐based lateral flow assay

“…Previous studies reported that lateral flow assay (LFA) was an ideal platform for diagnosing infectious pathogens (Nardo et al., 2021 ). The test strips currently in use in China mainly adopted paired mAbs against Y. pestis capsule like fraction 1 (F1) protein to detect plague infection (Jullien et al., 2020 ). This antigen has been used for more than a century as a major diagnostic marker and protective antigen (Chanteau et al., 2000 ; Tsui et al., 2015 ).…”