Usefulness of SARS‐CoV‐2 antigen test sample as input for SARS‐CoV‐2 RT‐PCR analysis

García-Salguero, Cristina; Culebras, Esther; Merino, Paloma; Baos, Elvira; Delgado‐Iribarren, Alberto

doi:10.1002/jmv.27459

Cited by 4 publications

(4 citation statements)

References 12 publications

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“…Several studies have shown a wide range of sensitivities associated with SARS-CoV-2 RADTs which is very dependent upon the viral load. Sensitivity can range from 95%, when a high concentration of viral capsid antigens are present in the sample, to 10–30% when the viral load is low ( 6 , 7 ). In most clinical cases, SARS-CoV-2 RADT results needed to be confirmed by qPCR.…”

Section: Introductionmentioning

confidence: 99%

Diagnostic accuracy of SARS-CoV-2 Panbio™ rapid antigen diagnostic tests in a 4,440-case clinical follow-up

et al. 2022

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Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Rapid Antigen Detection Testing (RADT) has been subjected to several evaluations in reference to diagnostic accuracy, ranging from small scale up to large population studies including nation-wide community-based studies. All confirmed the diagnostic accuracy of the tests which were strongly dependent upon the infection's population prevalence. In our retrospective study, parallel SARS-CoV-2 Panbio™ RADT assay, including real-time reverse transcription quantitative polymerase chain reaction (RT-qPCR) tests, were aimed to evaluate diagnostic performance regarding the rapid antigen diagnostic testing. Out of 4,440 paired tests, 609 samples tested positive using RT-qPCR, resulting in a prevalence of 13.7%. Panbio detected 251 (5.7%) positive tested samples. Overall sensitivity was 41.2% (95% CI 37.4–45.2%) and overall specificity was 99.7% (95% CI 99.4–99.8%). Positive predictive value (PPV) was 95.1% (95% CI 91.8–97.1%) and the negative predictive value (NPV) was 91.4% (95% CI 90.5–92.2%). RADT sensitivity increased with stratification in reference to the results according to PCR Cycle threshold (Ct) and presence of the symptoms considerably influenced PPV and NPV. Sensitivity in the group of Ct values ≤ 20 was 91.2%, 68.6% within the Ct range of 20–25, 47.9% in the group of Ct values between 25 and 30, and 12.6% in the group of Ct values between 30 and 35. A follow-up of the positive cases aligned with RT-qPCR testing and comparison of the general population enrolled in the testing in which the fatal cases occurred enabled us to estimate real clinical diagnostic performance regarding the SARS-CoV-2 Panbio RADT. Based upon our results, we recommend the SARS-CoV-2 Panbio RADT tests be carried out as the primary test, without parallel PCR testing, only among high population prevalence rates of the infection and to be used for symptomatic individuals with average or low severe disease developmental risk. In the case of high risk regarding the development of severe infection complications, a parallel SARS-CoV-2 RT-qPCR is needed to be carried out to attain proper diagnostic accuracy and avoid delaying appropriate medical care.

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Section: Introductionmentioning

confidence: 99%

Diagnostic accuracy of SARS-CoV-2 Panbio™ rapid antigen diagnostic tests in a 4,440-case clinical follow-up

et al. 2022

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“…Despite the wide availability of diagnostic tests, the sensitivity is related to the cycle threshold (Ct) value regardless of vaccine status and/or symptoms. All negative results must be verified using molecular assay [ 11 ].…”

Section: New Advances In Microbiological Diagnosis Of Sars-cov-2 Infe...mentioning

confidence: 99%

Microbiological and Clinical Findings of SARS-CoV-2 Infection after 2 Years of Pandemic: From Lung to Gut Microbiota

et al. 2022

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Early recognition and prompt management are crucial for improving survival in COVID-19 patients, and after 2 years of the pandemic, many efforts have been made to obtain an early diagnosis. A key factor is the use of fast microbiological techniques, considering also that COVID-19 patients may show no peculiar signs and symptoms that may differentiate COVID-19 from other infective or non-infective diseases. These techniques were developed to promptly identify SARS-CoV-2 infection and to prevent viral spread and transmission. However, recent data about clinical, radiological and laboratory features of COVID-19 at time of hospitalization could help physicians in early suspicion of SARS-CoV-2 infection and distinguishing it from other etiologies. The knowledge of clinical features and microbiological techniques will be crucial in the next years when the endemic circulation of SARS-CoV-2 will be probably associated with clusters of infection. In this review we provide a state of the art about new advances in microbiological and clinical findings of SARS-CoV-2 infection in hospitalized patients with a focus on pulmonary and extrapulmonary characteristics, including the role of gut microbiota.

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“…The disease can be detected soon after the first days of symptoms appear, not requiring a complex laboratory structure. However, these tests offer lower sensitivity and specificity when compared to RT-PCR and, sometimes, they must be repeated [ 9 ]. On the other hand, RT-PCR has better accuracy, even in the first days of infection, even before the onset of symptoms.…”

Section: Introductionmentioning

confidence: 99%

“…On the other hand, RT-PCR has better accuracy, even in the first days of infection, even before the onset of symptoms. As disadvantages, these tests have a higher cost, require a more complex laboratory structure and longer time to process the results [ 9 , 10 ].…”

Section: Introductionmentioning

confidence: 99%

Cost-effectiveness analysis of COVID-19 tests in the unified health system

Cedro,

de Lima Gomes,

Simões

et al. 2023

Cost Eff Resour Alloc

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Background To evaluate the cost-effectiveness ratio and economic impact of the Rapid Antigen Test (TR-Ag) to replace RT-PCR for the detection of the new Coronavirus in the Unified Health System (SUS). Methods This is a cost-effectiveness analysis. Clinical protocols were used for the diagnosis of COVID-19 at the São José Municipal Hospital, located in the city of Itaberá-SP. The Incremental Cost-Effectiveness Ratio (ICER) was divided into two scenarios. In the first, the accuracy reported by the test manufacturers was included, and in the second, the cost resulting from a systematic review. Both were compared with the performance of the RT-PCR test. The increase in diagnoses was chosen as a health outcome and absenteeism was used as a criterion for assessing the economic impact. Results The analysis resulted in incremental cost-effectiveness ratios of R$ 42,136.67 and R$ 68,329.73 for every thousand tests, according to the accuracy of the manufacturers’ TR-Ag tests and what is reported in the literature in relation to RT-PCR, respectively. The average value found for the RT-PCR test (R$ 202.87) represents an increase of 165.32% in cost in relation to the value found for the TR-Ag. 4,305 tests were performed between April 2020 and December 2021 at the referral hospital. Also, maintaining the use of RT-PCR as the first choice for diagnosing COVID-19 and regulating absenteeism in the economically active population could have an impact of up to R$ 1,022,779.68 on municipal management. Conclusion It is concluded that the TR-Ag are configured as a cost-effective alternative for the SUS in the detection of the new Coronavirus. The strategy becomes economically favorable for the expansion of testing, combating the COVID-19 pandemic and reducing the impact on the local economy. However, studies are needed to validate the accuracy of the tests so that economic evaluations on the subject are more assertive.

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Usefulness of SARS‐CoV‐2 antigen test sample as input for SARS‐CoV‐2 RT‐PCR analysis

Cited by 4 publications

References 12 publications

Diagnostic accuracy of SARS-CoV-2 Panbio™ rapid antigen diagnostic tests in a 4,440-case clinical follow-up

Diagnostic accuracy of SARS-CoV-2 Panbio™ rapid antigen diagnostic tests in a 4,440-case clinical follow-up

Microbiological and Clinical Findings of SARS-CoV-2 Infection after 2 Years of Pandemic: From Lung to Gut Microbiota

Cost-effectiveness analysis of COVID-19 tests in the unified health system

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