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Multicenter evaluation of the Panbio COVID-19 rapid antigen-detection test for the diagnosis of SARS-CoV-2 infection

Targets: The usual RT-PCR assay for COVID-19 is laborious and time-consuming, limiting the supply of testing. Fast antigen-detection exams are sooner and cheaper; nonetheless, the reliability of those exams should be validated earlier than they can be utilized extensively. The target of this research was to find out the efficiency of the PanbioTM COVID-19 Ag Fast Take a look at Gadget (PanbioRT) (Abbott) for SARS-CoV-2 in nasopharyngeal swab specimens.
Strategies: This potential multicenter research was carried out in ten Spanish college hospitals together with people with scientific signs or epidemiological standards for COVID-19. Solely people with ≤ 7 days from the onset of signs or from publicity to a confirmed case of COVID-19 have been included. Two nasopharyngeal samples have been taken to carry out the PanbioRT, as a point-of-care take a look at, and a diagnostic RT-PCR take a look at.
Outcomes: Among the many 958 sufferers studied, 325 (90.5%) had true-positives outcomes. The general sensitivity and specificity for the PanbioRT have been 90.5% (CI 95%: 87.5-93.6) and 98.8% (CI 95%: 98-99.7), respectively. Sensitivity in contributors who had a CT <25 for the RT-PCR take a look at was 99.5% (CI 95%: 98.4-100), and in contributors with ≤5 days of the scientific course was 91.8% (CI 95%: 88.8-94.8). Settlement between methods was 95.7% (kappa rating: 0.90; CI 95%: 0.88-0.93).
Conclusions: The PanbioRT supplies good scientific efficiency, with much more dependable outcomes for sufferers with a shorter scientific course of the illness or the next viral load. The outcomes should be interpreted based mostly on the native epidemiological context.

Panbio fast antigen take a look at for SARS-CoV-2 has acceptable accuracy in symptomatic sufferers in main well being care

Targets: We aimed to guage the accuracy of the Panbio™ Ag-RDT at main well being care (PHC) facilities and take a look at websites in symptomatic sufferers and shut contacts, utilizing the Reverse-Transcription Polymerase Chain Response (RT-PCR) take a look at because the gold normal.
Strategies: The research was carried out in 4 PHC facilities and two take a look at websites in Mallorca, Spain. Consecutive sufferers older than 18 years, attending the websites for RT-PCR testing have been included. Two nasopharyngeal samples have been collected, one for RT-PCR and the opposite was processed on-site utilizing the Panbio fast antigen take a look at equipment for SARS-CoV-2. The sensitivity and specificity have been calculated utilizing RT-PCR because the reference, and the predictive values utilizing the pretest likelihood outcomes for every analyzed group.
Findings: A complete of 1369 contributors have been included; imply age 42.5 ± 14.9 years and 54.3% ladies. The general prevalence was 10.2%. Most contributors (70.6%) introduced inside 5 days of the onset of signs.
The general sensitivity was of 71.4% (95% CI: 63.1%, 78.7%), the specificity of 99.8% (95% CI: 99.4%, 99.9%), the constructive predictive worth of 98.0% (95% CI: 93.0%, 99.7%) and a destructive predictive worth of 96.8% (95% CI: 95.7%, 97.7%). The sensitivity was larger in symptomatic sufferers, in these arriving inside 5 days since symptom onset and in these with excessive viral load.
Interpretation: Ag-RDT had comparatively good efficiency traits in suspected symptomatic sufferers inside 5 days for the reason that onset of signs. Nevertheless, our knowledge don’t help the only real use of Panbio™ Ag-RDT in asymptomatic people.

Actual-life validation of the Panbio COVID-19 antigen fast take a look at (Abbott) in community-dwelling topics with signs of potential SARS-CoV-2 an infection

Background: RT-qPCR is the reference take a look at for identification of energetic SARS-CoV-2 an infection, however is related to diagnostic delay. Antigen detection assays can generate outcomes inside 20 min and outdoors of laboratory settings. But, their diagnostic take a look at efficiency in actual life settings has not been decided.
Strategies: The diagnostic worth of the Panbio™ COVID-19 Ag Fast Take a look at (Abbott), was decided compared to RT-qPCR (Seegene Allplex) in community-dwelling mildly symptomatic topics in a medium (Utrecht, the Netherlands) and excessive endemic space (Aruba), utilizing two concurrently obtained nasopharyngeal swabs.Findings: 1367 and 208 topics have been enrolled in Utrecht and Aruba, respectively. SARS-CoV-2 prevalence, based mostly on RT-qPCR, was 10.2% (n = 139) and 30.3% (n = 63) in Utrecht and Aruba respectively.
The specificity of the Panbio™ COVID-19 Ag Fast Take a look at was 100% (95%CI: 99.7-100%) in each settings. Take a look at sensitivity was 72.6% (95%CI: 64.5-79.9%) within the Netherlands and 81.0% (95% CI: 69.0-89.8%) in Aruba. Likelihood of false destructive outcomes was related to RT-qPCR Ct-values, however not with period of signs. Limiting RT-qPCR take a look at positivity to Ct-values <32 yielded take a look at sensitivities of 95.2% (95%CI: 89.3-98.5%) in Utrecht and 98.0% (95%CI: 89.2-99.95%) in Aruba.
Interpretation: In community-dwelling topics with gentle respiratory signs the Panbio™ COVID-19 Ag Fast Take a look at had 100% specificity, and a sensitivity above 95% for nasopharyngeal samples when utilizing Ct-values <32 cycles as cut-off for RT-qPCR take a look at positivity. Contemplating quick turnaround instances, person friendliness, low prices and alternatives for decentralized testing, this take a look at can enhance our efforts to manage transmission of SARS-CoV-2.

Analysis of a fast antigen take a look at (Panbio™ COVID-19 Ag fast take a look at system) for SARS-CoV-2 detection in asymptomatic shut contacts of COVID-19 sufferers

Targets: There’s restricted data on the efficiency of fast antigen detection (RAD) exams to determine SARS-CoV-2-infected asymptomatic people. On this discipline research, we evaluated the Panbio™ COVID-19 Ag Fast Take a look at Gadget (Abbott Diagnostics, Jena, Germany) for this function.
Strategies: A complete of 634 people (355 feminine; median age, 37 years; vary, 9-87) have been enrolled. Two nasopharyngeal swabs have been collected from family (n=338) and non-household contacts (n=296) of COVID-19 circumstances. RAD testing was carried out on the level of care. The RT-PCR take a look at used was the TaqPath COVID-19 Combo Package (Thermo Fisher Scientific, Massachusetts, USA).
Outcomes: Family contacts have been examined at a median of two days (vary, 1-7) after prognosis of the index case, whereas non-household contacts (n=296) have been examined at a median of 6 days (vary, 1-7) after publicity. In complete, 79 people (12.4%) examined constructive by RT-PCR, of whom 38 (48.1%) yielded constructive RAD outcomes. The general sensitivity and specificity of the RAD take a look at was 48.1% (95% CI: 37.4-58.9) and 100% (95% CI: 99.3-100), respectively. Sensitivity was larger in family (50.8%; 95% CI: 38.9-62.5) than in non-household (35.7%; 95% CI:16.3-61.2%) contacts. People testing constructive by RAD take a look at have been extra seemingly (P<0.001) to develop into symptomatic than their destructive counterparts.
Conclusion: The Panbio take a look at shows low sensitivity in asymptomatic shut contacts of COVID-19 sufferers, significantly in non-household contacts. Nonetheless, establishing the optimum timing for higher respiratory tract assortment on this group appears crucial to pinpoint take a look at sensitivity.
milansystem
milansystem

Subject analysis of a fast antigen take a look at (Panbio COVID-19 Ag Fast Take a look at Gadget) for COVID-19 prognosis in main healthcare facilities

 

Targets: To our information no earlier research has assessed the efficiency of a fast antigen diagnostic immunoassay (RAD) carried out on the level of care (POC). We evaluated the Panbio™ COVID-19 Ag Fast Take a look at Gadget for COVID-19 prognosis in symptomatic sufferers (n=412) attended in main healthcare facilities.
Strategies: RAD was carried out instantly after sampling following the producer’s directions (studying at 15 min.). RT-PCRs have been carried out inside 24 h. of specimen assortment. Samples displaying discordant outcomes have been processed for tradition in Vero E6 cells. Presence of SARS-CoV-2 in cell cultures was confirmed by RT-PCR.
Outcomes: Out of 412 sufferers, 43 (10.4%) examined constructive by RT-PCR and RAD and 358 (86.9%) destructive by each strategies, exhibiting discordant outcomes (RT-PCR+/RAD-) in 11 sufferers (2.7%). General specificity and sensitivity of fast antigen detection (RAD) was 100% (95% CI, 98.7-100%), and 79.6% (95% CI, 67.-88.8%), respectively, taking RT-PCR because the reference.
General RAD destructive predictive worth for an estimated prevalence of 5% and 10% was 99% (95% CI, 97.4-99.6%) and 97.9% (95% CI, 95.9-98.9), respectively. SARS-CoV-2 couldn’t be cultured from specimens yielding RT-PCR+/RAD-results (n=11).
Conclusion: The Panbio COVID-19 Ag Fast Take a look at Gadget carried out nicely as a POCT for early prognosis of COVID-19 in main healthcare facilities. Extra crucially, the information advised that sufferers with RT-PCR-proven COVID-19 testing destructive by RAD are unlikely to be infectious.

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