Diagnostic performance of rapid antigen testing for SARS-CoV-2: the COVid-19 AntiGen (COVAG) extension study

BackgroundThis study is the extension of the COVAG study. We compared two RATs, the Panbio COVID-19 Ag Rapid Test (Abbott) and the SD Biosensor Q SARS-CoV-2 Rapid Antigen Test (Roche), against RT-PCR on the foil of new variants.MethodsWe included 888 all-comers at a diagnostic center between October 20, 2021, and March 18, 2022. RT-PCR-positive samples with a Ct value ≤32 were examined for SARS-CoV-2 variants.FindingsThe sensitivity of the Abbott-RAT and Roche-RAT were 65 and 67%, respectively. For both RATs, lower Ct values were significantly correlated with higher sensitivity. For samples with Ct values ≤25, the sensitivities of the Roche-RAT and of the Abbott-RAT were 96 and 95%, for Ct values 25–30 both were 19%, and for Ct values ≥30 they were 6 and 2%, respectively. The RATs had substantially higher sensitivities in symptomatic than asymptomatic participants (76, 77%, vs. 29, 31%, for Abbott-RAT, Roche-RAT, respectively) and in participants referred to testing by their primary care physician (84, 85%) compared to participants who sought testing due to referral by the health department (55, 58%) or a warning by the Corona-Warn-App (49, 49%). In persons with self-reported previous COVID-19 sensitivities were markedly lower than in patients without previous COVID-19: 27% vs. 75% for Roche-RAT and 27% vs. 73% for Abbott-RAT. We did not find significant correlation between vaccination status and sensitivity. The Omicron variant was detected with a sensitivity of 94 and 92%, the delta variant with a sensitivity of 80 and 80% for Abbott-RAT and Roche-RAT, respectively. This difference is attributable to the lower Ct values of the Omicron samples compared to the Delta samples. When adjusted for the Ct value, a multivariate logistic regression did not show a significant difference between Omicron and Delta. In terms of sensitivity, we found no significant difference between the wild-type and the Omicron and Delta variants, but a significantly lower sensitivity to the alpha variant compared to the other variants.The specificities were > 99% overall

Diagnostic Performance of Rapid Antigen Testing for SARS-CoV-2: The COVid-19 AntiGen (COVAG) study

Background Rapid diagnostic testing for SARS-Cov-2 antigens is used to combat the ongoing pandemic. In this study we aimed to compare two RDTs, the SD Biosensor Q SARS-CoV-2 Rapid Antigen Test (Roche) and the Panbio COVID-19 Ag Rapid Test (Abbott), against rRT-PCR. Methods We included 2,215 all-comers at a diagnostic center between February 1 and March 31, 2021. rRT-PCR-positive samples were examined for SARS-CoV-2 variants. Findings Three hundred and thirty eight participants (15%) were rRT-PCR-positive for SARS-CoV-2. The sensitivities of Roche-RDT and Abbott-RDT were 60.4 and 56.8% ( P < 0.0001) and specificities 99.7% and 99.8% ( P = 0.076). Sensitivity inversely correlated with rRT-PCR-Ct values. The RDTs had higher sensitivities in individuals referred by treating physicians (79.5%, 78.7%) than in those referred by health departments (49.5%, 44.3%) or tested for other reasons (50%, 45.8%), in persons without any comorbidities (74.4%, 71%) compared to those with comorbidities (38.2%, 34.4%), in individuals with COVID-19 symptoms (75.2%, 74.3%) compared to those without (31.9%, 23.3%), and in the absence of SARS-CoV-2 variants (87.7%, 84%) compared to Alpha variant carriers (77.1%, 72.3%). If 10,000 symptomatic individuals are tested of which 500 are truly positive, the RDTs would generate 38 false-positive and 124 false-negative results. If 10,000 asymptomatic individuals are tested, including 50 true positives, 18 false-positives and 34 false-negatives would be generated. Interpretation The sensitivities of the two RDTs for asymptomatic SARS-CoV-2 carriers are unsatisfactory. Their widespread use may not be effective in the ongoing SARS-CoV-2 pandemic. The virus genotype influences the sensitivity of the two RDTs. RDTs should be evaluated for different SARS-CoV-2 variants

Akūts sirds bojājumi un miokardīts Covid-19 pacientiem. Literatūras apskats

MedicīnaVeselības aprūpeMedicineHealth CareŠajā literatūras apskatā apkopoti pieejamie pētījumi un secinājumi par SARS-CoV-2 izraisītu sirds bojājumu un jo īpaši miokardītu. Literatūra tika meklēta un identificēta, izmantojot plašu PubMed meklēšanu, tostarp gadījumu ziņojumus, metaanalīzes, klīniskos pētījumus, sistemātiskus pārskatus un pārskatus. Akūts sirds bojājums ir bieži sastopams Covid-19 pacientiem, un paaugstināts troponīna līmenis kā sirds bojājuma pazīme ir cieši saistīts ar paaugstinātu nāves risku. Tomēr dati par SARS-CoV-2 un miokardītu ir mazāk skaidri. Vairāki novērojumu pētījumi rāda, ka pastāv saistība starp miokardītu un SARS-CoV-2, un skaitļi par miokardīta sastopamību Covid-19 gadījumā svārstās no 0,1 līdz 5 %. ACE2 kā SARS-CoV-2 iekļūšanas receptors un šūnu iekļūšanai nepieciešamās proteāzes ir izteiktas sirds audos. Tas kopā ar citokīnu vētru, hiperkoagulāciju un iespējamo vīrusa mimikriju ar sekojošiem autoimūniem procesiem sniedz izskaidrojumu Covid-19 sirds slimības patoģenētiskajam pamatojumam. Tomēr ir tikai daži pētījumi, kas liecina par SARS-CoV-2 tiešu iekļūšanu sirdī endomijokarda biopsijās un autopsijās, bet ir vairāk pētījumu, kas liecina, ka sirds audos nav vīrusa materiāla. Nelielie pierādījumi par histoloģiski pierādītu miokardītu Covid-19 gadījumā neļauj skaidri pierādīt SARS-CoV-2 izraisītu miokardītu. Ir arī vairāki ziņojumi par MIS-A (multisistēmas iekaisuma sindroms pieaugušajiem), kas izpaužas ar miokardītu vai vismaz kambaru disfunkciju un šoku pēc nesen pārciesta Covid-19. Pacienta, kurš nomira no MIS-A miokardīta, biopsijas laikā sirds audos konstatēja SARS-CoV-2 specifiskas T-šūnas. MIS-A varētu būt labs izskaidrojums pacientiem ar miokardītam līdzīgu klīnisko izpausmi pēc SARS-CoV-2 infekcijas. Daudzos pētījumos ir ziņots par miokardītu vai miokardītam līdzīgiem atradumiem sirds magnētiskās rezonanses izmeklējumos pacientiem ar Covid-19 vai pacientiem, kas jau izveseļojušies no Covid-19, norādot uz akūtu un ilgstošu SARS-CoV-2 ietekmi uz sirdi. Tomēr daudzi no šiem pacientiem bija asimptomātiski, un šo atradumu klīniskā nozīme joprojām nav skaidra.This literature review summarizes the available studies and findings about SARS-CoV-2 induced cardiac injury and myocarditis in particular. Literature was searched and identified by an extensive PubMed search including case reports, meta-analyses, clinical trials, systematic reviews, and reviews. Acute cardiac injury is a common finding in patients with Covid-19 and elevated troponin as a sign of cardiac injury is tightly associated with an increased risk for death. The data about SARS-CoV-2 and myocarditis however is less explicit. Multiple observation studies show that there is an association of myocarditis and SARS-CoV-2 with numbers on the incidence of myocarditis in Covid-19 varying between 0.1-5%. ACE2 as the entry receptor for SARS-CoV-2 and required proteases for cell entry are expressed in cardiac tissue. This together with cytokine storm, hypercoagulability and potential viral mimicry with subsequent autoimmune processes provide an explanation of the pathogenetic basis of cardiac involvement in Covid-19. However, there are only a few studies showing direct invasion of SARS-CoV-2 into the heart in endomyocardial biopsies and autopsies while there are more findings showing no viral material within heart tissue. The sparse evidence of histologically proven myocarditis in Covid-19 prohibits the clear proof of myocarditis due to SARS-CoV-2. There are also multiple reports on MIS-A (multisystem inflammatory syndrome in adults) presenting with myocarditis or at least ventricular dysfunction and shock after recent Covid-19. A biopsy of a patient who died by MIS-A myocarditis revealed T-cells specific for SARS-CoV-2 in cardiac tissue. MIS-A could be a good explanation for patients with a myocarditis-like clinical presentation after SARS-CoV-2 infection. Many studies report myocarditis or myocarditis-like-findings in cardiac magnetic resonance imaging in patients with Covid-19 or patients already recovered from Covid-19 indicating acute and prolonged effects of SARS-CoV-2 on the heart. However, many of these patients were asymptomatic and clinical significance of these findings remains unclear

Table_1_Diagnostic performance of rapid antigen testing for SARS-CoV-2: the COVid-19 AntiGen (COVAG) extension study.xlsx

BackgroundThis study is the extension of the COVAG study. We compared two RATs, the Panbio COVID-19 Ag Rapid Test (Abbott) and the SD Biosensor Q SARS-CoV-2 Rapid Antigen Test (Roche), against RT-PCR on the foil of new variants.MethodsWe included 888 all-comers at a diagnostic center between October 20, 2021, and March 18, 2022. RT-PCR-positive samples with a Ct value ≤32 were examined for SARS-CoV-2 variants.FindingsThe sensitivity of the Abbott-RAT and Roche-RAT were 65 and 67%, respectively. For both RATs, lower Ct values were significantly correlated with higher sensitivity. For samples with Ct values ≤25, the sensitivities of the Roche-RAT and of the Abbott-RAT were 96 and 95%, for Ct values 25–30 both were 19%, and for Ct values ≥30 they were 6 and 2%, respectively. The RATs had substantially higher sensitivities in symptomatic than asymptomatic participants (76, 77%, vs. 29, 31%, for Abbott-RAT, Roche-RAT, respectively) and in participants referred to testing by their primary care physician (84, 85%) compared to participants who sought testing due to referral by the health department (55, 58%) or a warning by the Corona-Warn-App (49, 49%). In persons with self-reported previous COVID-19 sensitivities were markedly lower than in patients without previous COVID-19: 27% vs. 75% for Roche-RAT and 27% vs. 73% for Abbott-RAT. We did not find significant correlation between vaccination status and sensitivity. The Omicron variant was detected with a sensitivity of 94 and 92%, the delta variant with a sensitivity of 80 and 80% for Abbott-RAT and Roche-RAT, respectively. This difference is attributable to the lower Ct values of the Omicron samples compared to the Delta samples. When adjusted for the Ct value, a multivariate logistic regression did not show a significant difference between Omicron and Delta. In terms of sensitivity, we found no significant difference between the wild-type and the Omicron and Delta variants, but a significantly lower sensitivity to the alpha variant compared to the other variants.The specificities were > 99% overall.</p