Accuracy of rapid point-of-care antigen-based diagnostics for SARS-CoV-2: An updated systematic review and meta-analysis with meta-regression analyzing influencing factors

PLoS Medicine, Journal Year: 2022, Volume and Issue: 19(5), P. e1004011 - e1004011

Published: May 26, 2022

Background Comprehensive information about the accuracy of antigen rapid diagnostic tests (Ag-RDTs) for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is essential to guide public health decision makers in choosing best and testing policies. In August 2021, we published a systematic review meta-analysis Ag-RDTs. We now update this work analyze factors influencing test sensitivity further detail. Methods findings registered on PROSPERO (registration number: CRD42020225140). systematically searched preprint peer-reviewed databases publications evaluating Ag-RDTs SARS-CoV-2 until 31, 2021. Descriptive analyses all studies were performed, when more than 4 available, random-effects was used estimate pooled specificity with reverse transcription polymerase chain reaction (RT-PCR) as reference. To evaluate sensitivity, performed 3 different using multivariable mixed-effects meta-regression models. included 194 221,878 performed. Overall, estimates Ag-RDT 72.0% (95% confidence interval [CI] 69.8 74.2) 98.9% CI 98.6 99.1). When manufacturer instructions followed, increased 76.3% 73.7 78.7). Sensitivity markedly better samples lower RT-PCR cycle threshold (Ct) values (97.9% [95% 96.9 98.9] 90.6% 88.3 93.0] Ct-values <20 <25, compared 54.4% 47.3 61.5] 18.7% 13.9 23.4] ≥25 ≥30) estimated increase by 2.9 percentage points 1.7 4.0) every unit decrease mean Ct-value adjusting procedure patients’ symptom status. Concordantly, found be true positive (22.2 21.5 22.8]) false negative (30.4 29.7 31.1]) results. Testing first week from onset resulted substantially higher (81.9% 77.7 85.5]) after 1 (51.8%, 95% 41.5 61.9). Similarly, symptomatic (76.2% 73.3 78.9]) asymptomatic (56.8% 50.9 62.4]) persons. However, both effects mainly driven sample. With regards sample type, highest nasopharyngeal (NP) combined NP/oropharyngeal (70.8% 68.3 73.2]), well anterior nasal/mid-turbinate (77.3% 73.0 81.0]). Our analysis limited studies’ heterogeneity viral load assessment origination. Conclusions detect most individuals infected SARS-CoV-2, almost (>90%) high loads are present. load, Ct-value, being influential factor their they especially useful persons who likely transmit virus. quantify other standardization clinical access patient level duration symptoms needed.

Language: Английский

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Analytical Sensitivity of Six SARS-CoV-2 Rapid Antigen Tests for Omicron versus Delta Variant

Viruses, Journal Year: 2022, Volume and Issue: 14(4), P. 654 - 654

Published: March 22, 2022

Rapid antigen detection (RAD) tests are commonly used for the diagnosis of SARS-CoV-2 infections. However, with continuous emergence new variants concern (VOC), presenting various mutations potentially affecting nucleocapsid protein, analytical performances these assays should be frequently reevaluated. One hundred and twenty samples were selected tested both RT-qPCR six commercial RAD that sold in Belgian pharmacies. Of these, direct whole-genome sequencing identified strains present 116 samples, which 70 Delta 46 Omicron (BA.1 BA.1.1 sub-lineages, respectively). The sensitivity across a wide range Ct values (13.5 to 35.7; median = 21.3) ranged from 70.0% 92.9% 69.6% 78.3% strains. When taking swabs low viral load (Ct > 25, corresponding <4.9 log10 copies/mL), only Roche test showed acceptable (80.0%), while poor observed other (20.0% 40.0%). All devices had (0.0% 23.1%). loads, particularly strain, is an important limitation tests, not sufficiently highlighted instructions use devices.

Language: Английский

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Diagnostic accuracy of covid-19 rapid antigen tests with unsupervised self-sampling in people with symptoms in the omicron period: cross sectional study

BMJ, Journal Year: 2022, Volume and Issue: unknown, P. e071215 - e071215

Published: Sept. 14, 2022

To assess the performance of rapid antigen tests with unsupervised nasal and combined oropharyngeal self-sampling during omicron period.Prospective cross sectional diagnostic test accuracy study.Three public health service covid-19 sites in Netherlands, 21 December 2021 to 10 February 2022.6497 people symptoms aged ≥16 years presenting for testing.Participants had a swab sample taken reverse transcription polymerase chain reaction (RT-PCR, reference test) received one perform using either (during emergence omicron, when accounted >90% infections, phase 1) or subsequent (phase 2; >99% infections). The evaluated were Flowflex (Acon Laboratories; 1 only), MPBio (MP Biomedicals), Clinitest (Siemens-Healthineers).The main outcomes sensitivity, specificity, positive negative predictive values each self-test, RT-PCR testing as standard.During 1, 45.0% (n=279) participants group, 29.1% (n=239) 35.4% ((n=257) group confirmatory testers (previously tested by self-test at own initiative). Overall sensitivities 79.0% (95% confidence interval 74.7% 82.8%) Flowflex, 69.9% (65.1% 74.4%) MPBio, 70.2% (65.6% 74.5%) Clinitest. Sensitivities substantially higher (93.6%, 83.6%, 85.7%, respectively) than those who other reasons (52.4%, 51.5%, 49.5%, respectively). decreased from 87.0% 80.9% (P=0.16 χ2 test), 80.0% 73.0% (P=0.60), 83.1% 70.3% (P=0.03), respectively, transitioning accounting 29% infections >95% infections. During 2, 53.0% (n=288) 44.4% (n=290) testers. 83.0% (78.8% 86.7%) 77.3% (72.9% 81.2%) When was compared self-sampling, found be slightly (87.4% 86.1%, (69.3% 59.9%, respectively).Sensitivities three but only statistically significant appeared influenced proportion improved after addition self-sampling. A result justifies prompt self-isolation without need testing. Individuals should adhere general preventive measures because false cannot ruled out. Manufacturers may consider extending their instructions use include manufacturers evaluating this well.

Language: Английский

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Performance of Antigen Detection Tests for SARS-CoV-2: A Systematic Review and Meta-Analysis

Diagnostics, Journal Year: 2022, Volume and Issue: 12(6), P. 1388 - 1388

Published: June 4, 2022

Coronavirus disease 2019 (COVID-19) initiated global health care challenges such as the necessity for new diagnostic tests. Diagnosis by real-time PCR remains gold-standard method, yet economical and technical issues prohibit its use in points of (POC) or repetitive tests populations. A lot effort has been exerted developing, using, validating antigen-based (ATs). Since individual studies focus on few methodological aspects ATs, a comparison different is needed. Herein, we perform systematic review meta-analysis data from articles PubMed, medRxiv bioRxiv. The bivariate method pooling sensitivities specificities was used. Most AT types SARS-CoV-2 were lateral flow immunoassays (LFIA), fluorescence (FIA), chemiluminescence enzyme (CLEIA). We identified 235 containing 220,049 individuals. All ATs using nasopharyngeal samples show better performance than those with throat saliva (72% compared to 40%). Moreover, rapid methods LFIA FIA about 10% lower sensitivity laboratory-based CLEIA 82%). In addition, higher symptomatic patients asymptomatic patients, suggesting that viral load crucial parameter performed POCs. Finally, all very high specificity, reaching around 99%. tests, though moderate sensitivity, appear most attractive POCs performing seroprevalence studies.

Language: Английский

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Portable microfluidic impedance biosensor for SARS-CoV-2 detection

Biosensors and Bioelectronics, Journal Year: 2023, Volume and Issue: 236, P. 115362 - 115362

Published: May 10, 2023

Language: Английский

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Evaluation of the Panbio COVID-19 Antigen Rapid Diagnostic Test in Subjects Infected with Omicron Using Different Specimens

Microbiology Spectrum, Journal Year: 2022, Volume and Issue: 10(3)

Published: June 2, 2022

Community testing is a crucial tool for the early identification of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and transmission control. The emergence highly mutated Omicron variant (B.1.1.529) raised concerns about its primary site replication, impacting sample collection detectability by rapid antigen tests. We tested performance Panbio diagnostic test (Ag-RDT) using nasal oral specimens COVID-19 diagnosis in 192 symptomatic individuals, with quantitative reverse transcription-PCR (RT-qPCR) nasopharyngeal samples as Variant concern (VOC) investigation was performed 4Plex SARS-CoV-2 screening kit. positivity rate 66.2%, 99% positive showing an amplification profile consistent that variant. Nasal Ag-RDT showed higher sensitivity (89%) than (12.6%) Ag-RDT. Our data good pandemic scenario dominated VOC. Furthermore, our also demonstrated does not provide swabs detection. IMPORTANCE This study COVID19 worked fine when it utilized patients infected variant, concordance PCR 93% tested. swab yielded more reliable results (the test) used

Language: Английский

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Performance and application evaluation of SARS‐CoV‐2 antigen assay

Journal of Medical Virology, Journal Year: 2022, Volume and Issue: 94(8), P. 3548 - 3553

Published: April 21, 2022

Abstract Severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) nucleic acid detection is the gold standard for laboratory diagnosis of disease 2019 (COVID‐19). However, this method has high requirements practitioners' skills and testing sites, so it not easy to popularize promote application in places other than large hospitals. In addition, flux SARS‐CoV‐2 small, whole process takes much time, which cannot meet actual needs rapid screening quantities. The WHO conditionally approved a batch antigen reagents clinical alleviate contradiction. offers trade‐off among performance, speed accessibility. With gradual increase application, accumulated data show that sensitivity specificity assay are over 80% 97%, respectively, can basically WHO. Antigen Assay asymptomatic people low prevalence areas COVID‐19 standard, leading number missed diagnoses. ability reagent different mutant strains differs greatly, especially those escaping vaccines. terms results interpretation, highly reliable exclude infection based on negative predictive value assay. environment, probability false positives high, positive need be confirmed by reagent. only supplement never completely replace it. To date, continues diagnosis.

Language: Английский

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Post-pandemic recommendations for the management of COVID-19 in patients with haematological malignancies or undergoing cellular therapy, from the European Conference on Infections in Leukaemia (ECIL-10)

Leukemia, Journal Year: 2025, Volume and Issue: unknown

Published: June 2, 2025

In the post-pandemic years, SARS-CoV-2 morbidity and mortality declined due to less pathogenic variants, active passive immunization, antiviral therapies. However, patients with hematological malignancies and/or undergoing hematopoietic cell transplantation (HCT) remain at increased risk for poor outcomes. Therefore, adherence contact droplet precautions is essential avoid transmission, especially during epidemic waves. Detection of viral RNA by nucleic acid testing naso-oro-pharyngeal samples gold standard diagnosis its high sensitivity specificity. Direct antigen allows rapid management decisions if positive, but has a low sensitivity, in asymptomatic patients. Active immunisation key prevention may require annual matching circulating variants. Passive immunization neutralizing anti-antibodies lost indication emergence immune escape Convalescent plasma been proposed not readily available most centres. For symptomatic patients, early treatment nirmatrelvir/ritonavir or remdesivir reduce progression severe-critical COVID-19. Prolonged administration, repeated courses, combination antivirals are considered clinical virological failure monotherapy. COVID-19, dexamethasone drugs downregulating inflammatory cytokine responses (anti-Il-6/anti-IL-2 agents, Janus kinase inhibitor) recommended, together best supportive intensive care, care should be exercised immunosuppressed Deferral chemotherapy, HCT conditioning, T-cell-based immunotherapy, T-cell engaging antibodies whereas deferral taken on case-by-case basis confirmed infection.

Language: Английский

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SARS-CoV-2 new variant BF.7: a new public threat globally, symptoms, precautions, transmission rate, and futures perspective – correspondence

International Journal of Surgery, Journal Year: 2023, Volume and Issue: 109(2), P. 181 - 183

Published: Jan. 24, 2023

Dear Editor, In Wuhan, China, an extremely unknown virulent pneumonia infected a vast number of people. At the beginning January 2020, authorities announced that new coronavirus disease 2019 (COVID-19) was culprit caused ailment. Then, strain viral given name 'Corona Virus Disease (COVID-19)' by WHO. This also referred to as 'severe acute respiratory syndrome 2' (SARS–CoV-2) when it classified International Committee on Taxonomy Viruses. As time passed, evolved into one most challenging issues contemporary society's public health, had already spread all nations worldwide. The WHO, 30 stated COVID-19 epidemic is health crisis global basis. 24 December 2022, 228 countries and throughout globe have disclosed total 661,343,977 patients diagnosed with coronavirus, 6,684,979 victims died result this pathogenic disease1. SARS-CoV-2 virus has undergone mutations over time, resulting in formation genetic diversity within community circulation strain. may affect features virus, such its transmission (for instance, could proliferate more quickly) or intensity effects affected person experience, cause severe conditions2. Among them, some notable variants are affecting people well killing UK variant (Alpha) (S-GSAS-B.1.1.7), South African (Beta) (S-GSAS-B.1.351), Indian (Delta) (B.1.617.2), B.1.1.28 (Brazilian variant)3–6. Studies shown (B.1.617.2) 70–80% aggressive than main variants7,8. Just around believed worst Coronavirus era behind them they might relax from COVID restrictions, news another deadly Omicron subvariant identified subcontinent India, which then renamed BF.7. seven instances been documented so far. Intense outbreaks reported spurred strain, according media sources. October, scientists researchers Gujarat Biotechnology Research Centre found first instance very contagious current count India four, three cases state Odisha. Officials department said BF.7 were recorded year occurred between July November9. patient who case discovered Odisha earlier now treated. After receiving treatment comfort their own homes, made full recovery. novel known quickly shorter incubation previous strains disease. It predicted during following 3 months, infect 60% China's whole population, spreading across Beijing, responsible for contributing substantial increase infections China. Additionally, several other territories, United States America Kingdom, European countries, Belgium, Germany, France, Denmark10. be traced back variation BA.5. highly variety time. greater potential produce re-infection can even persons vaccinated against A recent publication presented peer-reviewed journal Cell Host Microbe, 4.4 times tolerance neutralization original coronavirus. indicates antibodies produced vaccine not strong enough fight virus9,11 effectively. control epidemics must make use diagnostic technologies both rapid accurate identify choose suitable efficient treatments. PCR Rapid antigen tests performed confirm presence variant. They subvariants COVID-19; however, further testing necessary separate variations. reverse transcriptase-polymerase chain reaction, often RT-PCR, still way determine whether Omicron. test gold standard laboratory diagnosis SARS-CoV-2. S gene impacted mutations. addition, recognized looking genes code spike glycoprotein. RT-PCR kits green light primarily focus E, Rd, Rp, N genes11,12. Besides, broken down two parts: molecular diagnosis, comes first, immunological diagnostic, second. primary branches diagnostics real-time next-generation sequencing13. To search antigens antibodies. Through tests, RNA amplified, making possible diagnose infections. These sometimes 'nucleic acid amplification testing,' phrase describes them. thing done get sample possibly person's mouth nose because where hiding out. If contains SARS-CoV-2, approach detect millions copies genomic material. Collecting secretions nasopharyngeal surfaces, likely transmit carry out testing. Most assays available development employ oral material simplify indicate infected14. symptoms similar those subvariants. An infectious experience indications include fever, cough, sore throat, runny nose, tiredness, vomiting, diarrhea. addition this, stuffy exhaustion, phlegm15. People compromised immune systems at higher risk developing conditions exposed subvariant. prevent infection subvariant, keeping safe distance crucial. Maintain 6 ft settings, Centers Control Prevention recommends. Keeping someone whooping sneezing assist avoiding obtaining germs. Always remember put mask before leaving home. By doing so, will only defends but ailments flu, cold, cough. using once, should rid it. Use high quality well. taking booster dosage Covid right now. Since cannot cured, protect oneself disease's vaccination15. Ethical approval Not applicable. Sources funding None. Author contribution M.M.R., S.A., M.R.I.: conceptualization writing – draft preparation; M.M.R.: writing, editing, supervision. All authors reviewed approved final version manuscript prior submission. Conflicts interest disclosure declare no conflicts interest, financial otherwise. registration unique identifying (UIN) None Guarantor M.M. Rahman (corresponding author), take responsibility work and/or conduct study, access data controlled decision publish. Data availability manuscript.

Language: Английский

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Ten rapid antigen tests for SARS-CoV-2 widely differ in their ability to detect Omicron-BA.4 and -BA.5

Medical Microbiology and Immunology, Journal Year: 2023, Volume and Issue: 212(5), P. 323 - 337

Published: Aug. 10, 2023

Abstract Since late 2021, the variant landscape of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been dominated by concern (VoC) Omicron and its sublineages. We others have shown that detection Omicron-BA.1 -BA.2-positive specimens rapid antigen tests (RATs) is impaired compared to Delta VoC-containing samples. Here, in a single-center retrospective laboratory study, we evaluated performance ten most commonly used RATs for Omicron-BA.4 -BA.5 infections. 171 swab from SARS-CoV-2 RNA-positive patients, which 71 were classified as BA.4 100 BA.5. All swabs collected between July September 2022. 50 PCR-negative samples healthy individuals, October 2022, showed high specificity 9 out 10 RATs. When assessing analytical sensitivity using clinical specimens, 50% limit (LoD50) ranged 7.6 × 4 3.3 6 RNA copies subjected 6.8 3.0 Overall, intra-assay differences these two subvariants not significant both tissue culture-expanded virus isolates. In contrast, marked heterogeneity was observed among RATs: be positive point-of-care tests, up 443-fold (BA.4) 56-fold (BA.5) higher viral loads required worst performing RAT best RAT. True-positive rates Omicron-BA.4- or -BA.5-containing highest load category ( C t values < 25) 94.3 34.3%, dropping 25.6 0% with intermediate (25–30). conclude remains challenge general public obtain reliable results evolving subvariant-driven pandemic.

Language: Английский

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