Diagnostic validation of two SARS-CoV-2 immunochromatographic tests in Slovenian and Croatian hospitals

Ifko, Martina; Švabek, Željka Tkalčić; Friščić, Iva; Paro, Mirjana Mariana Kardum; Prkačin, Ingrid; Đerek, Lovorka; Livun, Ana; Skvarč, Miha

doi:10.3325/cmj.2021.62.513

Cited by 4 publications

(1 citation statement)

References 5 publications

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“…However, because it was conducted in local settings with high COVID-19 prevalence, its specificity performance may be overestimated, especially when all test samples' Ct values have not been fully obtained. In the study of Ifko et al (n=333), ALLTEST also showed a satisfactory sensitivity result of 85.0% [25]. The study did not elaborate on the procedures of the sampling operation, but it mentioned that the positive or presumed false negative samples were subsampled by the same health worker, which probably means that the experimental design was not implemented in a blinded method.…”

Section: Resultsmentioning

confidence: 99%

Diagnostic Accuracy of Rapid Antigen Tests for SARS-CoV-2 Approved for Use in China

Li¹

2023

HSET

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Rapid antigen tests (RATs), a simple, inexpensive test that can be performed at home by residents, have been widely used in COVID-19 diagnosis around the world. Until 29th April 2022, the Chinese National Medical Products Administration (CNMPA) has approved a total of 31 items of RAT products. Review the existing research evaluating the diagnostic accuracy of CNMPA-approved RATs, then collect the raw data of included texts, calculate the sensitivity and specificity in each study, and compare them with these two aspects to provide optimal choice for RAT used in real-life practice. Using the Cochrane and WHO COVID-19 databases, studies with full texts published between 2020-2022 were included if they aimed detection for SARS-CoV-2 infection, had CNMPA-approved RAT for index testing and compared with RT-PCR results. Studies were excluded if they failed to provide primary data for accuracy testing or the data provided did not allow the calculation of sensitivity or specificity. No language restrictions were applied in this review, and all study designs that provided diagnostic accuracy data were accepted. Results: 22 studies were included in this review. All CNMPA-approved RATs included in the review performed well in diagnostic specificity except for four individual studies. However, the sensitivity of CNMPA-approved RATs varied widely among different RATs and different studies. The two worst sensitivity-performing RATs were Savant and LEPU, while the best was Wondfo.

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Section: Resultsmentioning

confidence: 99%

Diagnostic Accuracy of Rapid Antigen Tests for SARS-CoV-2 Approved for Use in China

Li¹

2023

HSET

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The Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19: Antigen Testing (January 2023)

Hayden

Hanson

Englund

et al. 2023

Clinical Infectious Diseases

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Background Immunoassays designed to detect SARS-CoV-2 protein antigens (Ag) are commonly used to diagnose COVID-19. The most widely used tests are lateral flow assays that generate results in approximately 15 minutes for diagnosis at the point-of-care. Higher throughput, laboratory-based SARS-CoV-2 Ag assays have also been developed. The number of commercially available SARS-CoV-2 Ag detection tests has increased rapidly, as has the COVID-19 diagnostic literature. The Infectious Diseases Society of America (IDSA) convened an expert panel to perform a systematic review of the literature and develop best practice guidance related to SARS-CoV-2 Ag testing. This guideline is an update to the third in a series of frequently updated COVID-19 diagnostic guidelines developed by the IDSA. Objective The IDSA’s goal was to develop evidence-based recommendations or suggestions that assist clinicians, clinical laboratories, patients, public health authorities, administrators and policymakers in decisions related to the optimal use of SARS-CoV-2 Ag tests in both medical and non-medical settings. Methods A multidisciplinary panel of infectious diseases clinicians, clinical microbiologists and experts in systematic literature review identified and prioritized clinical questions related to the use of SARS-CoV-2 Ag tests. A review of relevant, peer-reviewed published literature was conducted through April 1, 2022. Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology was used to assess the certainty of evidence and make testing recommendations. Results The panel made ten diagnostic recommendations. These recommendations address Ag testing in symptomatic and asymptomatic individuals and assess single versus repeat testing strategies. Conclusions U.S. Food and Drug Administration (FDA) SARS-CoV-2 Ag tests with Emergency Use Authorization (EUA) have high specificity and low to moderate sensitivity compared to nucleic acid amplification testing (NAAT). Ag test sensitivity is dependent on the presence or absence of symptoms, and in symptomatic patients, on timing of testing after symptom onset. In contrast, Ag tests have high specificity, and, in most cases, positive Ag results can be acted upon without confirmation. Results of point-of-care testing are comparable to those of laboratory-based testing, and observed or unobserved self-collection of specimens for testing yields similar results. Modeling suggests that repeat Ag testing increases sensitivity compared to testing once, but no empirical data were available to inform this question. Based on these observations, rapid RT-PCR or laboratory-based NAAT remains the testing method of choice for diagnosing SARS-CoV-2 infection. However, when timely molecular testing is not readily available or is logistically infeasible, Ag testing helps identify individuals with SARS-CoV-2 infection. Data were insufficient to make a recommendation about the utility of Ag testing to guide release of patients with COVID-19 from isolation. The overall quality of available evidence supporting use of Ag testing was graded as very low to moderate.

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Comparison of diagnostic accuracy of rapid antigen tests for COVID-19 compared to the viral genetic test in adults: a systematic review and meta-analysis

Hirabayashi,

Mercado,

Hull

et al. 2024

JBI Evidence Synthesis

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Objective: The objective of this review is to determine the diagnostic accuracy of the currently available and upcoming point-of-care rapid antigen tests (RATs) used in primary care settings relative to the viral genetic real-time reverse transcriptase polymerase chain reaction (RT-PCR) test as a reference for diagnosing COVID-19/SARS-CoV-2 in adults. Introduction: Accurate COVID-19 point-of-care diagnostic tests are required for real-time identification of SARS-CoV-2 infection in individuals. Real-time RT-PCR is the accepted gold standard for diagnostic testing, requiring technical expertise and expensive equipment that are unavailable in most primary care locations. RATs are immunoassays that detect the presence of a specific viral protein, which implies a current infection with SARS-CoV-2. RATs are qualitative or semi-quantitative diagnostics that lack thresholds that provide a result within a short time frame, typically within the hour following sample collection. In this systematic review, we synthesized the current evidence regarding the accuracy of RATs for detecting SARS-CoV-2 compared with RT-PCR. Inclusion criteria: Studies that included nonpregnant adults (18 years or older) with suspected SARS-CoV-2 infection, regardless of symptomology or disease severity, were included. The index test was any available SARS-CoV-2 point-of-care RAT. The reference test was any commercially distributed RT-PCR–based test that detects the RNA genome of SARS-CoV-2 and has been validated by an independent third party. Custom or in-house RT-PCR tests were also considered, with appropriate validation documentation. The diagnosis of interest was COVID-19 disease and SARS-CoV-2 infection. This review considered cross-sectional and cohort studies that examined the diagnostic accuracy of COVID-19/SARS-CoV-2 infection where the participants had both index and reference tests performed. Methods: The keywords and index terms contained in relevant articles were used to develop a full search strategy for PubMed and adapted for Embase, Scopus, Qinsight, and the WHO COVID-19 databases . Studies published from November 2019 to July 12, 2022, were included, as SARS-CoV-2 emerged in late 2019 and is the cause of a continuing pandemic. Studies that met the inclusion criteria were critically appraised using QUADAS-2. Using a customized tool, data were extracted from included studies and were verified prior to analysis. The pooled sensitivity, specificity, positive predictive, and negative predictive values were calculated and presented with 95% CIs. When heterogeneity was observed, outlier analysis was conducted, and the results were generated by removing outliers. Results: Meta-analysis was performed on 91 studies of 581 full-text articles retrieved that provided true-positive, true-negative, false-positive, and false-negative values. RATs can identify individuals who have COVID-19 with high reliability (positive predictive value 97.7%; negative predictive value 95.2%) when considering overall performance. However, the lower level of sensitivity (67.1%) suggests that negative test results likely need to be retested through an additional method. Conclusions: Most reported RAT brands had only a few studies comparing their performance with RT-PCR. Overall, a positive RAT result is an excellent predictor of a positive diagnosis of COVID-19. We recommend that Roche’s SARS-CoV-2 Rapid Antigen Test and Abbott’s BinaxNOW tests be used in primary care settings, with the understanding that negative results need to be confirmed through RT-PCR. We recommend adherence to the STARD guidelines when reporting on diagnostic data. Review registration: PROSPERO CRD42020224250

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Diagnostic validation of two SARS-CoV-2 immunochromatographic tests in Slovenian and Croatian hospitals

Cited by 4 publications

References 5 publications

Diagnostic Accuracy of Rapid Antigen Tests for SARS-CoV-2 Approved for Use in China

Diagnostic Accuracy of Rapid Antigen Tests for SARS-CoV-2 Approved for Use in China

The Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19: Antigen Testing (January 2023)

Comparison of diagnostic accuracy of rapid antigen tests for COVID-19 compared to the viral genetic test in adults: a systematic review and meta-analysis

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