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The Performance of Lateral Flow Tests in the Age of the Omicron: A Rapid Systematic Review.

ABSTRACT: Prompt detection and isolation of COVID-19 cases is vital for preventing further viral transmission, and lateral flow or rapid antigen tests have been an important diagnostic tool in this pandemic. However, concerns have emerged regarding the sensitivity of these devices for the new BA.1, BA.2, and BA.4/5 omicron variants, which have greater transmissibility and extensive mutations in its spike (S) and nucleocapsid (N) proteins. N protein is an important target protein for existing lateral flow devices. This paper therefore aimed to provide a rapid review of available literature on the performance of the lateral flow tests for detecting the omicron coronavirus variant. A systematic literature search of PubMed, EMBASE, OVID Medline, and Google Scholar found six published studies and four preprints investigating the performance of existing lateral flow devices for the omicron variant, as compared to the B.1.617.2 (Delta) variant. Overall, it appears that the devices have poorer performance for the omicron variant and when testing samples with cycle threshold (Ct) values greater than 25 and in asymptomatic individuals. As most available data were preliminary and had small sample sizes, it is recommended that these data be further studied to better inform and adapt our public health responses.

SUBMITTER: Ng QX

PROVIDER: S-EPMC9695766 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature

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The Performance of Lateral Flow Tests in the Age of the Omicron: A Rapid Systematic Review.

Ng Qin Xiang QX Lim Yu Liang YL Han Ming Xuan MX Teoh Seth En SE Thumboo Julian J Tan Ban Hock BH

Life (Basel, Switzerland) 20221121 11

Prompt detection and isolation of COVID-19 cases is vital for preventing further viral transmission, and lateral flow or rapid antigen tests have been an important diagnostic tool in this pandemic. However, concerns have emerged regarding the sensitivity of these devices for the new BA.1, BA.2, and BA.4/5 omicron variants, which have greater transmissibility and extensive mutations in its spike (S) and nucleocapsid (N) proteins. N protein is an important target protein for existing lateral flow ...[more]

PMID: 36431077

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Project description:BackgroundLateral flow tests (LFTs) have been used to screen for SARS-CoV2 in Wales since January 2021. Between May and August 2021, adult care home staff policy was for biweekly Innova LFT and weekly Polymerase Chain Reaction (PCR) testing while asymptomatic. We estimated test performance of LFTs conducted in adult care home staff using PCR tests as a reference standard.MethodsTest results from surveillance data were matched by individual where both LFT and PCR were taken on the same day. We calculated sensitivity, specificity, positive and negative predictive values, and agreement using Matthew's correlation coefficient. Ct values of positive PCR results were compared by matched LFT result. Analysis was conducted using R v4.1.3.ResultsWe analysed 115,593 test pairs, 499 (0.43%) of which were PCR positive. Median age was 48 (IQR: 22) and 85.00% of the study population were female. Test result agreement was 99.59% (95%CI 99.55-99.63; MCC: 0.38, p<0.001). Sensitivity and specificity were 25.65% (95%CI 22.02-29.67) and 99.91% (95%CI 99.89-99.93), respectively. PPV was 55.90% (95%CI 49.42-62.17) and NPV was 99.68% (95%CI 99.64-99.71). Crude Ct values were significantly lower in positive PCR tests matched to a positive LFT compared to a negative LFT.ConclusionsSpecificity and negative predictive value were high in an asymptomatic population of care home staff indicating this test is an effective tool for identifying cases of SARS-CoV-2 infection during periods of high prevalence where transmission is likely, due to the presence of high viral loads. Positive predictive value results are lower than existing literature yet should be considered in light of the asymptomatic study population and low prevalence (under 1%) at the time most of these tests were conducted. Performance improved at times of higher prevalence during the study. These results suggest that whilst lateral flow tests are effective for identifying SARS-COV-2 infections with high viral loads, they are not effective at identifying cases with a low viral load. When an LFT provides a negative result, false negatives should be considered and additional diagnostic tests performed.

Project description:BackgroundTo overcome the limitations of conventional malaria rapid diagnostic tests (cRDTs) in diagnosing malaria in patients with low parasitaemia, ultrasensitive malaria rapid diagnostic tests (uRDTs) have recently been developed, with promising results under laboratory conditions. The current study is the first meta-analysis comparing the overall sensitivity, and specificity of newly developed ultrasensitive Plasmodium falciparum malaria RDT (Alere™ Ultra-sensitive Malaria Ag P. falciparum RDT) with the cRDT conducted in the same field conditions.MethodsPubMed, EMBASE, Cochrane infectious diseases group specialized register, and African Journals Online (AJOL) were searched up to 20th April 2021. Studies with enough data to compute sensitivity and specificity of uRDT and cRDT were retrieved. A random-effect model for meta-analysis was used to obtain the pooled sensitivity and specificity.ResultsOverall, 15 data sets from 14 studies were included in the meta-analysis. The overall sensitivity of the Alere™ ultra-sensitive Malaria Ag P. falciparum RDT regardless of the reference test and the clinical presentation of participants, was 55.5% (95% confidence interval [CI]: 45.5; 65.0), while the sensitivity regardless of the reference test and the clinical presentation of participants, was 42.9% (95% CI: 31.5; 55.2) for the cRDT performed in the same field conditions. When PCR was used as reference test, the sensitivity of uRDT was 60.4% (95% CI: 50.8; 69.2), while the sensitivity was 49.4% (95% CI: 38.2; 60.6) for the cRDT. The pooled specificity of uRDT regardless of the reference test and the clinical presentation of participants was 98.6% (95% CI: 97.1; 99.4), and the pooled specificity of cRDT regardless of the reference test and the clinical presentation of participants was 99.3% (95% CI: 98.1; 99.7). When PCR was used as reference test the specificity of uRDT and cRDT was 97.5% (95% CI: 94.1; 98.9) and 98.2% (95% CI: 95.5; 99.3). Regardless of the reference test used, the sensitivity of Alere™ Ultra-sensitive Malaria Ag P. falciparum RDT in symptomatic patients was 72.1% (95%CI: 67.4; 76.4), while sensitivity of cRDT was 67.4% (95%CI: 57.6; 75.9).ConclusionFindings of the meta-analysis show that Alere™ Ultra-sensitive Malaria Ag P. falciparum RDT compared to cRDT performed in the same field conditions has higher sensitivity but lower specificity although the difference is not statistically significant.

Dataset Information

The Performance of Lateral Flow Tests in the Age of the Omicron: A Rapid Systematic Review.

Publications

The Performance of Lateral Flow Tests in the Age of the Omicron: A Rapid Systematic Review.

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