4.6 Review

Association Between Rapid Antigen Detection Tests and Real-Time Reverse Transcription-Polymerase Chain Reaction Assay for SARS-CoV-2: A Systematic Review and Meta-Analyses

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Summary: This study aimed to compare the performance of Lumipulse(R) antigen immunoassay with real-time RT-PCR in diagnosing SARS-CoV-2 infection in asymptomatic individuals. The results showed an overall agreement rate of 97% between Lumipulse(R) antigen assay and real-time RT-PCR, with a sensitivity of 96% and a specificity of 98%. The sensitivity varied based on the cycle threshold (C-t) value, reaching 100% for 15 < C-t < 25 and 86% for C-t >= 25. The study concluded that Lumipulse(R) antigen assay could be an effective tool in identifying and limiting SARS-CoV-2 transmission in large asymptomatic populations.

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Comparative evaluation of four rapid SARS-CoV-2 antigen detection tests using universal transport medium

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Sung Jin Jo et al.

Summary: Rapid antigen tests, such as the MARK-B COVID-19 Ag test, show high sensitivity and specificity in detecting SARS-CoV-2 infections. The use of magnetic force-assisted electrochemical immunoassay-based tests can provide quick and reliable results for the prevention of COVID-19 spread.

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Validation of the STANDARD Q COVID-19 antigen test in Vojvodina, Serbia

Mioljub Ristic et al.

Summary: The study evaluated the clinical performance of STANDARD Q COVID-19 Ag Test in 120 symptomatic patients, showing higher sensitivity in the early phase of disease and strong agreement with RT-qPCR results within the first five days of illness. The rapid antigenic test can be very useful for COVID-19 diagnosis in the early phase of disease.

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Clinical performance of the Abbott Panbio with nasopharyngeal, throat, and saliva swabs among symptomatic individuals with COVID-19

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Summary: The Panbio antigen test helps combat COVID-19 by reliably detecting SARS-CoV-2 in symptomatic adults within 7 days of symptom onset using nasopharyngeal swabs. However, throat and saliva swabs are not suitable for Panbio testing.

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Rapid COVID-19 antigenic tests: Usefulness of a modified method for diagnosis

Reza Soleimani et al.

Summary: This study evaluated the performances of two rapid antigen testing devices in detecting SARS-CoV-2 in nasopharyngeal samples, showing relatively high sensitivity, especially with lower cycle threshold values, and 100% specificity for both devices.

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Summary: This study evaluated the performance of an antigen-based rapid diagnostic test (RDT) for detecting the SARS-CoV-2 virus, finding low sensitivity and suggesting it is not suitable for screening patients with low viral load, emphasizing the continued use of RT-qPCR as the gold standard test.

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Evaluation of rapid SARS-CoV-2 antigen tests, AFIAS COVID-19 Ag and ichroma COVID-19 Ag, with serial nasopharyngeal specimens from COVID-19 patients

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Summary: The study evaluated the diagnostic accuracy of two newly developed rapid antigen tests for SARS-CoV-2, finding that they showed excellent specificity and acceptable sensitivity for specimens with higher viral loads and those collected within 7 days post-symptom onset.

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Saliva Is a Valid Alternative to Nasopharyngeal Swab in Chemiluminescence-Based Assay for Detection of SARS-CoV-2 Antigen

Alessandra Amendola et al.

Summary: The study evaluated the performance of a chemiluminescence-based SARS-CoV-2 antigen detection method in saliva samples, showing high reliability and accuracy, especially in individuals with high viral loads. However, in a low prevalence setting, confirmatory testing is still necessary to improve the positive predictive value.

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Evaluation of the AMP SARS-CoV-2 rapid antigen test in a hospital setting

Georg Leixner et al.

Summary: The study showed that the AMP RAT has high sensitivity in specific cases and may be helpful for frontline testing when rRT-PCR is not readily available.

INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES (2021)

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Performance of SARS-CoV-2 rapid antigen test compared with real-time RT-PCR in asymptomatic individuals

Monica Pena et al.

Summary: This study compared a SARS-CoV-2 RAT and RT-PCR in 842 asymptomatic individuals from Tarapaca, Chile, reporting RAT might have a significant impact in some regions, especially in situations lacking laboratory conditions or requiring rapid results.

INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES (2021)

Article Medical Laboratory Technology

Diagnostic performance of the Elecsys SARS-CoV-2 antigen assay in the clinical routine of a tertiary care hospital: Preliminary results from a single-center evaluation

Thomas Mueller et al.

Summary: This study found that the Elecsys SARS-CoV-2 antigen assay has low sensitivity for detecting SARS-CoV-2 from nasopharyngeal swabs, leading to the decision not to use this assay in the clinical routine of the hospital.

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Efficacy comparison of three rapid antigen tests for SARS-CoV-2 and how viral load impact their performance

Laurent Blairon et al.

Summary: This study evaluated the performance of three rapid antigen tests for SARS-CoV-2 diagnosis under varying viral loads, showing higher sensitivities in samples with higher viral loads. However, the sensitivities of all three tests dropped significantly when viral loads decreased, with GSD NovaGen showing lower specificity. Although not suitable for routine testing in high throughput laboratories, these tests can still be useful in quickly identifying highly infectious patients and screening close contacts in environments without easy access to molecular tests.

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Performance of the Innova SARS-CoV-2 antigen rapid lateral flow test in the Liverpool asymptomatic testing pilot: population based cohort study

Marta Garcia-Finana et al.

Summary: The study revealed that the sensitivity of LFT compared to RT-qPCR was low but with high specificity in asymptomatic adults. LFT may have better detection rates for individuals with high viral loads. However, the potential for missing cases, even at high viral loads, should be considered when using a single LFT in high-risk settings.

BMJ-BRITISH MEDICAL JOURNAL (2021)

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Evaluation of Two Rapid Antigenic Tests for the Detection of SARS-CoV-2 in Nasopharyngeal Swabs

Ysaline Seynaeve et al.

Summary: The study evaluated the performance of two new antigen detection kits in laboratory settings, with HeRDT showing a higher sensitivity compared to CoRDT. Despite excellent specificity, the poor sensitivity of CoRDT makes it unsuitable for rapid diagnosis of COVID-19.

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Diagnostic Accuracy of Rapid Antigen Test Kits for Detecting SARS-CoV-2: A Systematic Review and Meta-Analysis of 17,171 Suspected COVID-19 Patients

Shahad Saif Khandker et al.

Summary: The study evaluated the overall performance of rapid antigen tests (RAT) in the diagnosis of SARS-CoV-2, finding a specificity and sensitivity of 99.4% and 68.4% respectively. Nasopharyngeal specimens and symptomatic patient's samples were found to be more sensitive in RAT, while the cycle threshold (Ct) values had an inverse relationship with sensitivity. RAT showed better performance in European and American populations, indicating it could be used as an alternative diagnostic tool.

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Summary: Accurate and rapid diagnostic tests for SARS-CoV-2 infection are crucial for managing the COVID-19 pandemic. Point-of-care antigen and molecular tests can increase access to testing and expedite clinical and public health management decisions. Studies show that antigen tests have varying sensitivity, with higher accuracy in the first week of infection, and the efficacy of molecular tests depends on the specific brand used.

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Summary: The antigen rapid test showed high specificity and sensitivity in community-dwelling residents in the Netherlands and Aruba, especially when using a Ct value <32 cycles as the cut-off for RT-qPCR positivity. This test could play a significant role in controlling viral spread.

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