PanbioTM COVID-19 Ag Rapid Test Research Articles

Evaluation of Rapid Antigen Testing (Panbio™ COVID-19 Ag Rapid Test Device) for COVID-19 Diagnosis in a Tertiary Hospital

Evaluation of Rapid Antigen Testing (Panbio™ COVID-19 Ag Rapid Test Device) for COVID-19 Diagnosis in a Tertiary Hospital

Evaluation of Rapid Antigen Testing (Panbio™ COVID-19 Ag Rapid Test Device) for COVID-19 Diagnosis in a Tertiary Hospital

Evaluation of Rapid Antigen Testing (Panbio™ COVID-19 Ag Rapid Test Device) for COVID-19 Diagnosis in a Tertiary Hospital

The sensitivity and specificity of Abbott Panbio™ COVID 19 Ag Rapid test in the context of four SARS-CoV-2 variants

Rapid antigen tests for the detection of SARS-CoV-2 are commonly used for the diagnosis of Covid-19. Previously published data showed a wide range of sensitivity and specificity of RATs, but these studies were performed on relatively small numbers of samples and using only limited numbers of virus variants. The aim of the study was to evaluate the main parameters of a commonly used RAT for 4 different virus variants in comparison with PCR. Material and methodsA set of 2874 samples obtained from Covid-19 patients were examined both by PCR and RAT. Two commercial PCR kits (Generi Biotech, Diana Biotechnologies) and one RAT – Abbott Panbio™ COVID 19 Ag Rapid – were compared for their sensitivity and specificity in samples positive for one of the four different SARS-CoV-2 variants – B.1.258 (n = 496), Alpha (n = 645), Delta/Delta+ (n = 687), and Omicron (n = 1046). ResultsThe sensitivity of Panbio™ COVID19 Ag Rapid test varied from 80.0 % in Omicron to 88.92 % in Alpha variants. The specificities of the RAT for all variants reached above 93 %. Statistically significant differences were found between the results from RAT assay in select virus variants. In addition, significantly higher sensitivity (p < 0.05) was detected in samples with higher viral loads than in those with lower. ConclusionDespite the different sensitivity and specificity of Panbio™ COVID19 Ag Rapid test (Abbott ®) for different SARS-CoV-2 variants, this test sensitivity was proven to be always above the 80 % suggested by WHO, which makes it suitable for common use, regardless of the virus variability.

Rapid antigen test as a screening tool for SARS-CoV-2 infection: Head-to-head comparison with qRT-PCR in Ethiopia

ObjectiveThis study aimed to determine the diagnostic accuracy of the antigen rapid diagnostic test (Ag-RDT) as a screening tool for SARS-CoV-2 infection compared to Quantitative reverse transcription polymerase chain reaction (qRT-PCR). MethodsThis study was conducted at six referral hospitals in Oromia Region, Ethiopia. One thousand seven hundred twenty-one patients who visited the hospitals for various medical conditions were tested with qRT-PCR and/or Ag-RDTs. Qualitative detection of SARS-CoV-2 antigen was performed using the Panbio™ COVID-19 Ag rapid test device. ResultsCompared with qRT-PCR, Ag-RDTs had a sensitivity of 33.3 % (95%CI: 30.9%–35.9 %) and a specificity of 99.3 % (95%CI: 98.8%–99.7 %) to detect active SARS-CoV-2 infection. The area under the receiver operator curve was 0.67 (95%CI: 0.63–0.69). The sensitivity of Ag-RDTs appeared high in patients with shortness of breath (73.3 %) and those presenting with all three symptoms – fever, cough, and dyspnea (71.4 %). In all instances, specificity was more than 98 %. The Ag-RDT positivity rate also correlated well with viral load: 51.7 % in cases with cycle threshold (Ct) < 25 (high viral load) and only 3.4 % when Ct > 25 (low viral load). ConclusionAlthough Ag-RDT for diagnosing SARS-CoV-2 is a good option as a point-of-care screening tool, it has a low sensitivity to detect active infections. Using Panbio™ COVID-19 Ag Rapid test for diagnostic and treatment decisions may lead to a false negative, resulting in patient misdiagnosis, ultimately contributing to disease spread and poor patient outcome.

Evaluation of the Abbott Panbio™ COVID-19 Ag Rapid Antigen Test for Asymptomatic Patients during the Omicron Wave

Rapid antigen testing (RAT) is a cost-effective and time-efficient method of identifying severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and therefore a critical part of infection control strategies. There is no published evidence evaluating the use of RAT during the Omicron wave of the COVID-19 pandemic for asymptomatic patients or its performance between waves. All patients presenting to an Emergency Department over a two-week period without COVID-19 symptoms were screened for SARS-CoV-2 using both the Abbott Panbio RAT as well as the gold standard reverse transcriptase real-time polymerase chain reaction (PCR). The Abbott Panbio RAT sensitivity was 13% (95% CI 0.028, 0.336) for asymptomatic patients. The use of this test in asymptomatic patients during the Omicron wave had a statistically significant reduction in sensitivity compared with two reports of the same test in previous waves (13% vs. 86%, p &lt; 0.0001; 13% vs. 83%, p &lt; 0.0001). As SARS-CoV-2 continues to mutate, the sensitivity of RATs are altered and needs to be continually re-evaluated for each variant of concern if they are to be used as part of an infection control strategy.

Evaluation of Four Rapid Antigen Tests for the Detection of SARS-CoV-2 Infection with Nasopharyngeal Swabs

Owing to the high transmissibility of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants, the capacity of testing systems based on the gold standard real-time reverse transcription-polymerase chain reaction (rRT-PCR) is limited. Rapid antigen tests (RATs) can substantially contribute to the prevention of community transmission, but their further assessment is required. Here, using 1503 nasopharyngeal swabs, we compared the diagnostic performance of four RAT kits (Abbott Panbio™ COVID-19 Ag Rapid Test, SD Biosensor Standard™ Q COVID-19 Ag Test, Humasis COVID-19 Ag Test, and SG Medical Acrosis COVID-19 Ag Test) to the cycle threshold (Ct) values obtained from rRT-PCR. The precision values, area under the curve values, SARS-CoV-2 variant detection ability, and non-SARS-CoV-2 specificity of all four kits were similar. An assay using the Acrosis kit had a significantly better positive detection rate with a higher recall value and cut-off value than that using the other three RAT kits. During the current COVID-19 pandemic, the Acrosis kit is an effective tool to prevent the spread of SARS-CoV-2 in communities.

English

This study aimed to evaluate the performance of the PanbioTM Covid-19 Ag Rapid Test (Abbott) in a medical center in Ouagadougou. The PanbioTM COVID-19 Ag test was evaluated from January 26 to March 31, 2021 in symptomatic and asymptomatic patients in the medical Centre of Kossodo. A total of 268 individuals were tested by both SARS-CoV-2 RT-PCR, and antigen RDT. Of these 268 individuals, 52 were positive and 216 were negative for COVID-19 RT-PCR. The performance parameters of the test and its Kappa agreement with the RT-PCR were calculated according to the presence or absence of symptoms in the patients on one hand, and according to the time onset of symptoms on the other hand. The sensitivity of the Panbio&trade; COVID-19 Ag Rapid Test ranged from 29.63% (95% CI: 13.75 to 50.18) among COVID-19 asymptomatic patients, to 87.5% (95% CI: 52.91 to97.76) among symptomatic patients with symptom onset time of 1-5 days. Similarly, the Panbio&trade; COVID-19 Ag Rapid Test specificity was 97.3% (95% CI: 90.58 to 99.67) and 96.4% (95% CI: 91.81 to 98.82) in symptomatic and asymptomatic RT PCR negative patients. The Panbio&trade; COVID-19 Ag Rapid Test shows good performance in detecting COVID-19 cases in patients with a symptom onset time of less than seven (7) days. This performance is even better when the symptom onset is reduced to five (5) days. The results show that the antigen RDT is not suitable for&nbsp;&nbsp; COVID-19 detection among asymptomatic patients. &nbsp; Key words: COVID-19, SARS-CoV-2, diagnosis, antigen test, rapid test, point-of-care.

Analytical sensitivity of six lateral flow antigen test kits for variant strains of SARS-CoV-2

IntroductionThe lateral flow antigen test is a useful tool for rapid diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. The analytical sensitivity of six lateral flow antigen test kits was compared. MethodsThe limit of detection (LoD) and time to positive results were evaluated for six lateral flow tests including ImmunoArrow®, ESPLINE® SARS-CoV-2, QuickNavi™ COVID19 Ag, ImmunoAce® SARS-CoV-2, Panbio™ COVID-19 Ag Rapid Test Device, and SARS-CoV-2 Rapid Antigen Test using the heat-inactivated virus. The LoD of ImmunoArrow® against the Omicron variants was compared with that against the wild-type using recombinant proteins. ResultsImmunoArrow® and ESPLINE® showed the lowest LoD. The time to positive results of all tests except for ESPLINE® was within 200 s in the evaluation at high dose of antigens (2.5 × 105 TCID50/mL) and 500 s in the evaluation at low dose of antigens (2.5 × 104 TCID50/mL). The LoD of ImmunoArrow® against the Omicron variants was the same concentration against the wild-type antigen. ConclusionsImmunoArrow® detected SARS-CoV-2 antigens including the Omicron variants with good sensitivity among the six lateral flow antigen tests. These finding support that it can support the rapid diagnosis of COVID-19 with the good sensitivity.

Efficacy Of PanbioTM Covid-19 Ag Rapid Test In Sars-Cov-2 Detection: Comparison With RT-PCR Test.

Evidence on performance of Rapid Antigen Detection Tests to recognize SARS-CoV-2 symptomatic patients in our context is limited. This study was aimed to evaluate Panbio™ COVID-19 Ag Rapid Test Device (Abbott Diagnostics, Jena, Germany) in identifying SARS-CoV-2 infection in comparison with RT-PCR test. This cross-sectional validation study was carried out at Margalla Hospital, Taxila from October, 2020 to March, 2021. Three hundred and eighty-two participants of both gender and all ages, symptomatic for 3-4 days were included in this study. For each participant, two nasopharyngeal swabs were collected by trained lab technicians according to SOPs, one for Rapid Antigen Test and other for RT-PCR.Covid-19 antibodies were checked 4-6 weeks after symptoms among 77 randomly selected participants to further evaluate the performance of Rapid Antigen Test. Data was analyzed using SPSS-26. The mean age of the participants was 43.1 years (SD=15.9). More than half of participants were males (n=213%=55.8) and 169 (44.2%) were females. Sensitivity of Rapid Antigen Test was calculated to be 94.3%, whereas the specificity was 39.7%. Out of 34 RT-PCR negatives that were initially detected positive on Rapid Antigen Test, 33 demonstrated presence of COVID-19 antibodies. Panbio™ COVID-19 Ag Rapid Test was found to have 93.4% overall sensitivity and relatively low overall specificity (37.9%). Rapid antigen testing using Panbio™ COVID-19 Ag Rapid Test Device can be effectively used to scale up mass testing to interrupt transmissibility of COVID-19 infection by generating quick result.

Low sensitivity of the COVID-19 antigen test (PANBIO™ COVID-19 Ag rapid test) to detect asymptomatic infections in health personnel of the National Institute of Respiratory Diseases.

BackgroundCOVID-19 requires an early diagnosis to optimize management and limit transmission. SARS-CoV-2 is able to spread effectively. Infected asymptomatic individuals have been found to be contagious. RT-qPCR is the currently recommended laboratory method for diagnosing acute infection. However, rapid antigen detection (RAD) tests are not only fast, but require less specialized training. The possibility of using RAD tests to identify asymptomatic patients is attractive, as it could effectively contribute to minimizing the hospital spread of SARS-CoV-2. The objective of the study was to determine the performance of RAD vs. RT-qPCR for the detection of asymptomatic cases in INER health personnel.MethodsIn order to follow WHO guidelines, generalized tests, a test station for health care workers was implemented on demand. A rapid test was carried out and a second sample was taken to be processed by RT-qPCR. With the results of both tests we conducted a retrospective study. Sensitivity, specificity, positive predictive value, negative predictive value and negative likelihood ratios were calculated.ResultsA total of 1640 RAD tests were performed in health care workers (mean age was 39, 69, 47% with a self-reported comorbidity). Participants provided 1,640 valid RAD/RT-qPCR test pairs with 2% testing positive via RT-qPCR. 12 RAD samples were positive for SARS-CoV-2. Overall sensitivity of the PANBIO ™ COVID-19 Ag Rapid Test test was 35.2%.ConclusionsRADs are not recommended for the detection of asymptomatic cases due to low performance.

Field evaluation of the performance of seven Antigen Rapid diagnostic tests for the diagnosis of SARs-CoV-2 virus infection in Uganda.

The objective of this study was to evaluate the performance of seven antigen rapid diagnostic tests (Ag RDTs) in a clinical setting to identify those that could be recommended for use in the diagnosis of SARS-CoV-2 infection in Uganda. This was a cross-sectional prospective study. Nasopharyngeal swabs were collected consecutively from COVID-19 PCR positive and COVID-19 PCR negative participants at isolation centers and points of entry, and tested with the SARS-CoV-2 Ag RDTs. Test sensitivity and specificity were generated by comparing results against qRT-PCR results (Berlin Protocol) at a cycle threshold (Ct) cut-off of ≤39. Sensitivity was also calculated at Ct cut-offs ≤29 and ≤33. None of the Ag RDTs had a sensitivity of ≥80% at Ct cut-off values ≤33 and ≤39. Two kits, Panbio™ COVID-19 Ag and VivaDiag™ SARS-CoV-2 Ag had a sensitivity of ≥80% at a Ct cut-off value of ≤29. Four kits: BIOCREDIT COVID -19 Ag, COVID-19 Ag Respi-Strip, MEDsan® SARS-CoV-2 Antigen Rapid Test and Panbio™ COVID-19 Ag Rapid Test had a specificity of ≥97%. This evaluation identified one Ag RDT, Panbio™ COVID-19 Ag with a performance at high viral load (Ct value ≤29) reaching that recommended by WHO. This kit was recommended for screening of patients with COVID -19-like symptoms presenting at health facilities.

Comparative field study of Rapid-Antigen Detection (RAD) with Multiplex Real Time-PCR for COVID-19 diagnosis

RT-PCR is a gold standard test for the diagnosis of SARS-CoV2 (Covid-19) infection; however, it is an expensive, time consuming and technical demanding technique. Rapid antigen detection immunoassay (RAD) is cost-effective, quick as well as can be performed and interpreted easily. The rapid diagnosis of COVID-19 patients is essential to reduce cost and control the disease spread; however, the real world data of these tests must be validated with RT-PCR before they can be used at large scale. The objective of this study was to determine the sensitivity and specificity of PanbioTMCOVID-19 Ag-Rapid test device (Abbot) with multiplex RT-PCR. METHODS: A total of n=3509 samples were tested for SARS-CoV-2 RAD and RT-PCR at Institute of Biomedical and Genetic Engineering, Islamabad. The rapid antigen tests were performed by PanbioTMCOVID-19 Ag-Rapid test device (Abbott) and compared with RT-PCR performed on Thermo Fisher (ABI) Quant Studio 5 using CDC 2019-nCoV RT-PCR protocol. RESULTS: Total (n=3509), n=458 (7.60%) samples were reported positive by rapid antigen out of which n= 445 RT-PCR positive (13 false positive by rapid antigen), n=3051 (92.4%) were negative. True antigen negative tests n= 3051) were repeated with RT-PCR among these, n=25 were observed RT-PCR positive (rapid antigen false negative). The threshold cycle (CT) for the RT-PCR tests of these samples was &gt;30. CONCLUSION: PanbioTMCOVID-19 Ag-Rapid test devices (Abbott) showed a sensitivity ratio 94.6% compared to RT-PCR. The PanbioTMCOVID-19 Ag-Rapid test device (Abbott) is reliable and can be used for screening and isolation of positive patients from the population.

Evaluation of the Panbio™ COVID-19 ag rapid test at an emergency room in a hospital in São Paulo, Brazil

BackgroundThe performance characteristics of the Panbio™ COVID-19 Ag test was evaluated at an emergency room setting against RT-PCR, considered the gold-standard for the detection of SARS-CoV-2, in São Paulo, Brazil. The study aimed to determine the sensitivity, specificity, Positive Percent Agreement (PPA), and Negative Percent Agreement (NPA) as compared to RT-PCR. MethodsSpecimens from 127 suspected patients were tested by both the Panbio™ COVID-19 Ag test and by RT-PCR. ResultsIn relation to RT-PCR using Ct values ≤ 40 as the upper limit for positivity, the Panbio™ COVID-19 Ag test showed an overall sensitivity of 84.3% (95% CI 75‒93.8%) and 98.2% (95% CI 96‒98.8%) overall specificity. For Ct values ≤ 25 (n = 37), the Panbio™ COVID-19 Ag test showed 97% sensitivity. DiscussionThe concordance between the Panbio™ COVID-19 Ag test and RT-PCR was 97% at Ct values below 25 but decreased at higher Ct values. For disease control, it is very important to identify infected individuals who present COVID-19 symptoms and also those who are suspected of infection due to contact with infected individuals. ConclusionThe Panbio™ COVID-19 Ag test is suitable for use as a diagnostic test for rapid screening of patients presenting COVID-19 symptoms, or those suspected of being infected, prior to being admitted to hospital.

Evaluation of SARS-CoV-2 rapid antigen diagnostic tests for saliva samples

Using saliva samples would facilitate sample collection, diagnostic feasibility, and mass screening of SARS-CoV-2. We tested two rapid antigen (RAD) immunochromatographic tests designed for detection of SARS-CoV-2 in saliva: Rapid Response™ COVID-19 Antigen Rapid Test Cassette for oral fluids and DIAGNOS™ COVID-19 Antigen Saliva Test. Evaluation of detection limit was performed with purified SARS-CoV-2 nucleocapsid protein and live SARS-CoV-2 virus. Sensitivity and specificity were further evaluated with reverse transcription quantitative PCR (RT-qPCR) positive and negative saliva samples from hospitalized individuals with COVID-19 (n = 39) and healthcare workers (n = 20). DIAGNOS showed higher sensitivity than Rapid Response for both nucleocapsid protein and live virus. The limit of detection of the saliva test from DIAGNOS was further comparable with the Abbott Panbio™ COVID-19 Ag Rapid Test designed for nasopharyngeal samples. DIAGNOS and Rapid Response detected nine (50.0%) and seven (38.9%), respectively, of the 18 RT-qPCR positive saliva samples. All RT-qPCR negative saliva (n = 41) were negative with both tests. Only one of the RT-qPCR positive saliva samples contained infectious virus as determined by cell culture and was also positive using the saliva RADs. The results show that the DIAGNOS may be an important and easy-to-use saliva RAD complement to detect SARS-CoV-2 positive individuals, but validation with a larger sample set is warranted.

Performance Validation of COVID-19 Self-Conduct Buccal and Nasal Swabs RTK-Antigen Diagnostic Kit.

The antigen rapid diagnostic test (Ag-RDT) is an immunodiagnostic test that detects the presence of viral proteins (antigens) expressed by the COVID-19 virus in a sample from a patient’s respiratory tract. This study focused on evaluating the performance of self-conduct buccal and nasal swabs RTK-antigen test compared to nasopharyngeal swab RTK-based COVID-19 diagnostic assays, Panbio™ COVID-19 Ag Rapid Test Device (Nasopharyngeal) (Abbott Rapid Diagnostics Jena GmbH, Jena, Germany) used in hospitals for first-line screening. The sensitivity and specificity of the paired RTK-Ag test in detecting the an-tigen were calculated at 96.4% and 100%, respectively. Fisher exact tests showed the association between nasopharyngeal swabs RTK-Ag assay and buccal-nasal swabs RTK-Ag from ProdetectTM is significant (p-values < 0.001). The result showed that a self-conducted buccal and nasal RTK-antigen rapid test by the patients is comparable to the results obtained from a rapid test device conducted by trained medical personnel using a nasopharyngeal swab.

Performance of an alternative RT-PCR procedure using residual sample from the Panbio™ Ag COVID-19 test

IntroductionIn the current standard of care (SoC) RT-PCR method for COVID-19, the patient's swab was extracted in viral transport media (VTM). For the Panbio™ COVID-19 Ag Rapid Test, the patient swab is flushed out in extraction buffer, of which a small fraction is used for testing, leaving more than half the sample unused. This study was designed to show that RT-PCR results from the residual sample of the Panbio™ COVID-19 Ag Rapid Test (called Novel RT-PCR) are not worse than the SoC RT-PCR result. MethodsThe study was performed using (1) dilution series of five patient samples, and (2) 413 patient samples comparing SOC versus Novel RT-PCR results. ResultsFor the dilution series samples, all tested positive by both methods. The bias between Ct values of Novel RT-PCR and SoC RT-PCR did not exceed 3.00 Ct using primers N1 and N2. A total of 413 COVID symptomatic patients seeking COVID testing were tested, of which 89 patients tested positive and 324 tested negative with SoC RT-PCR. In 324 patients who tested negative with SoC RT-PCR, 323 tested negative with Novel RT-PCR, and one (1) tested positive. Out of 89 who tested positive with SoC RT-PCR, 80 tested positive with the Novel RT-PCR, and nine patients showed a negative test result. The Overall Percent Agreement for the 413 valid patient sample pairs was 97.5 [95% CI 97 to 98]. ConclusionThe study demonstrated that the performance of the Novel RT-PCR method is acceptable compared to the SoC RT-PCR method and can be a useful tool to perform RT-PCR without the need for new swab collections.

"The effectiveness of rapid antigen test-based for SARS-CoV-2 detection in nursing homes in Valencia, Spain".

The usefulness of the PANBIO ™ COVID-19 Ag rapid test for SARS-CoV-2 infection detection has not been widely studied, especially in specific population groups such as the elderly who are institutionalized. Rapid diagnostic tests have the potential to benefit testing strategies, as they have short turnaround times, they are cheap, simple to perform and can be used in decentralized testing. The objective of this study is to show the performance of the PANBIO™ COVID-19 Ag Rapid test device conducted at geriatric institutions and to compare results to those obtained from RT-PCR. A total of 448 individuals were enrolled in the study, including both residents and employees. Nasopharyngeal swabs were collected for both PANBIO™ COVID-19 Ag Rapid test and RT-PCR testing. All the samples were analyzed by specialized microbiologists. A total of 117 out of 448 individuals (26%) tested positive by RT-PCR, of whom 99 (85%) returned positive Antigen test results. There were 18 Antigen negative cases with positive RT-PCR results. Accordingly, concordance between RT-PCR and Antigen test results was acceptable (K index, 0.89; 95% IC 0.8455–0.9345). Overall sensitivity and specificity of Antigen test was 85% and 100%, respectively. When defining RT-PCR CT positivity on a cut-off value of 35, LFA sensitivity was 90%. In case a cut-off value of 30 was used, LFA would increase up to 99%. In this real-life evaluation of the PANBIO™ COVID-Ag rapid test, the assay reliably identified SARS-CoV-2 infected individuals with low CT-values by RT-PCR. False negative results were observed only at high CT-values, meaning low viral loads in nasopharyngeal samples.

Evaluation of the Abbott PanbioTM COVID-19 Ag rapid antigen test for the detection of SARS-CoV-2 in asymptomatic Canadians

Several rapid testing methodologies have been approved for testing of symptomatic individuals but have not been validated for asymptomatic screening. We evaluated performance of the Abbott PanbioTM COVID-19 rapid antigen assay in the asymptomatic setting. We conducted a prospective study in an urban assessment center and in the context of long-term care staff screening. A total of 3014 individuals submitted paired nasopharyngeal samples, which were tested in parallel with the rapid antigen and laboratory-based, RT-PCR assays SARS-CoV-2 detection. There was 54.5% concordance in positive results between the rapid antigen assay and RT-PCR. All positive rapid antigen assay results were confirmed by RT-PCR. The negative predictive value of the rapid antigen assay minimally improved on the negative pre-test probability of SARS-CoV-2 infection. The Abbott PanbioTM COVID-19 rapid antigen test allowed for faster identification of infected individuals but cannot be used to rule-out SARS-CoV-2 infection.

Evaluation of a rapid antigen detection test (Panbio™ COVID-19 Ag Rapid Test Device) as a point-of-care diagnostic tool for COVID-19 in a pediatric emergency department.

We evaluated the Panbio™ COVID‐19 Ag Rapid Test Device as a point‐of‐care diagnostic tool for COVID‐19 in 357 patients at a pediatric emergency department. Thirty‐four patients tested positive by reverse transcription polymerase chain reaction, of which 24 were positive by the antigen assay. The sensitivity and specificity of the assay were 70.5% and 100%, respectively.

EVALUATION OF THREE COVID-19 ANTIGEN ASSAY VERSUS PCR DETECTION IN ROUTINE PRACTICE

According to WHO, molecular testing is the "Gold Standard" for the diagnosis of SARS-CoV-2 infection. However, these tests have some limitations in practice (well trained staff, specific equipment requirements, organization of area and time frame for reporting results). Thus, rapid antigen test (RAT) for the detection of one or several SARS-CoV-2 antigens have emerged. We evaluated the analytical performance of 3 RAT used in our laboratory : FREND® Ag COVID-19 (NanoEntek) (FA), STANDARD Q COVID-19 Ag (SD Biosensor) (BA), PANBIO™ COVID-19 Ag RAPID TEST DEVICE (Abbott) (PA) in comparaison to rRT-PCR results. Our study indicates that PA and SA antigen tests have a very good sensitivity to identify infected patients with COVID-19 specifically between in the 0-5 days time-window post onset of symptoms. Nevertheless, one out of three antigen tests (FA) showed very poor clinical performance.