Performance of SARS-CoV-2 antigen-detection rapid diagnostic tests for COVID-19 self-testing and self-sampling in comparison to molecular and professional-use antigen tests: A systematic review and meta-analysis DOI Creative Commons
Stephan Katzenschlager,

Lukas E. Brümmer,

Stephani Schmitz

et al.

Research Square (Research Square), Journal Year: 2023, Volume and Issue: unknown

Published: Aug. 21, 2023

Abstract Purpose Self-testing is an effective tool to bridge the testing gap for several infectious diseases; however, its performance in detecting SARS-CoV-2 using antigen-detection rapid diagnostic tests (Ag-RDTs) has not been systematically reviewed. To inform WHO guideline development, we evaluated accuracy of COVID-19 self-testing and/or self-sampling Ag-RDTs. Methods: We searched multiple databases articles evaluating or through November 7th, 2022. Cohen’s kappa was estimated assess concordance between self-testing/self-sampling and fully professional-use Ag-RDT results. Bivariate meta-analysis performed obtain pooled estimates compared molecular testing. The QUADAS-2 GRADE tools were used evaluate quality certainty evidence. Results: Among 43 studies included review, twelve reported on self-testing, while 31 assessed only. risk bias low 49.6% studies. Overall with Ag-RDTs (n = 7 datasets) high (kappa 0.92 [95% confidence interval (CI) 0.89 0.95]). sensitivity specificity 54 70.5% (95% CI 64.3 76.0) 99.4% 99.1–99.6), respectively. Conclusion: Despite heterogeneity among studies, exhibits This suggest that can be offered as part strategies. Trial registration PROSPERO: CRD42021250706

Language: Английский

Evaluation of the Diagnostic Performance of a SARS-CoV-2 and Influenza A/B Combo Rapid Antigen Test in Respiratory Samples DOI Creative Commons
Harika Öykü Dinç, Nuran Karabulut, Sema Alaçam

et al.

Diagnostics, Journal Year: 2023, Volume and Issue: 13(5), P. 972 - 972

Published: March 3, 2023

This study aimed to evaluate the performance characteristics of a rapid antigen test developed detect SARS-CoV-2 (COVID-19), influenza A virus (IAV), and B (IBV) (flu) compared with those real-time reverse transcription-polymerase chain reaction (rRT-PCR) method. One hundred SARS-CoV-2, one IAV, twenty-four IBV patients whose diagnoses were confirmed by clinical laboratory methods included in patient group. Seventy-six patients, who negative for all respiratory tract viruses, as control The Panbio™ COVID-19/Flu A&B Rapid Panel kit was used assays. sensitivity values 97.5%, 97.9%, 33.33% IBV, respectively, samples viral load below 20 Ct values. 16.7%, 36.5%, 11.11% above Ct. kit's specificity 100%. In conclusion, this demonstrated high IAV loads values, but not compatible PCR positivity lower over tests may be preferred routine screening tool communal environments, especially symptomatic individuals, when diagnosing caution.

Language: Английский

Citations

13

Comparing SARS-CoV-2 antigen-detection rapid diagnostic tests for COVID-19 self-testing/self-sampling with molecular and professional-use tests: a systematic review and meta-analysis DOI Creative Commons
Stephan Katzenschlager,

Lukas E. Brümmer,

Stephani Schmitz

et al.

Scientific Reports, Journal Year: 2023, Volume and Issue: 13(1)

Published: Dec. 11, 2023

Abstract Self-testing is an effective tool to bridge the testing gap for several infectious diseases; however, its performance in detecting SARS-CoV-2 using antigen-detection rapid diagnostic tests (Ag-RDTs) has not been systematically reviewed. This study aimed inform WHO guidelines by evaluating accuracy of COVID-19 self-testing and self-sampling coupled with professional Ag-RDT conduct interpretation. Articles on this topic were searched until November 7th, 2022. Concordance between self-testing/self-sampling fully professional-use Ag-RDTs was assessed Cohen’s kappa. Bivariate meta-analysis yielded pooled estimates. Quality certainty evidence evaluated QUADAS-2 GRADE tools. Among 43 studies included, twelve reported self-testing, 31 only. Around 49.6% showed low risk bias. Overall concordance high (kappa 0.91 [95% confidence interval (CI) 0.88–0.94]). Comparing molecular testing, sensitivity specificity 70.5% (95% CI 64.3–76.0) 99.4% 99.1–99.6), respectively. Higher (i.e., 93.6% 90.4–96.8] Ct < 25) estimated subgroups higher viral loads values as a proxy. Despite heterogeneity among studies, exhibits Ag-RDTs. suggests that can be offered part strategies. Trial registration: PROSPERO: CRD42021250706.

Language: Английский

Citations

11

Novel High‐Throughput Electrochemical Detection of Staphylococcus Aureus, Bacillus Cereus, or Micrococcus Luteus Using AuNPs@Ti3C2Tz Functionalized with Sandwich Peptides DOI Open Access
Jaehwan Park, My−Van Tieu, Thi Xoan Hoang

et al.

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

Published: March 18, 2025

Abstract Affinity‐based electrochemical biosensors hold promise for detecting pathogenic bacteria in environmental applications. This study focuses on gram‐positive bacteria, which can cause fatal infections and are a major global mortality factor. An biosensor platform using high‐throughput 16‐channel gold disk electrodes (16‐GDEs) inspired by bio‐microelectromechanical systems (BioMEMS) is developed, it incorporates nanocomposite (AuNPs@Ti 3 C 2 T z ) with sandwich peptide structures to enhance electroconductivity biological antifouling. Using AuNPs@Ti ‐coated 16‐GDEs, sensitive ( Staphylococcus aureus , Bacillus cereus or Micrococcus luteus constructed validated fresh‐water samples spiking showed linear correlations between normalized peak current logarithmic concentrations of the target (adjusted R‐square ≥ 0.93). A single containing S. M. B. also exhibiting specific responses without any cross‐reactivity real samples. enabled simultaneous detection multiple analytes (500 CFU mL⁻¹) be applied detect analyte suitable pair. The strategy implement quantitative real‐time polymerase chain reaction (RT‐qPCR) adaptive sensing device successfully bacteria. nanocomposite‐enabled 16‐GDEs offers valuable tool clinical diagnostics.

Language: Английский

Citations

0

Performance evaluation of STANDARD Q COVID‐19 Ag home test for the diagnosis of COVID‐19 during early symptom onset DOI Creative Commons
Hyoshim Shin, Seung Jun Lee, Kristin Widyasari

et al.

Journal of Clinical Laboratory Analysis, Journal Year: 2022, Volume and Issue: 36(6)

Published: April 20, 2022

Surveillance and control of SARS-CoV-2 outbreak through gold standard detection, that is, real-time polymerase chain reaction (RT-PCR), become a great obstacle, especially in overwhelming outbreaks. In this study, we aimed to analyze the performance rapid antigen home test (RAHT) as an alternative detection method compared with RT-PCR.In total, 79 COVID-19-positive 217 COVID-19-negative patients confirmed by RT-PCR were enrolled study. A duration from symptom onset COVID-19 confirmation <5 days was considered recruiting criterion for cases. nasal cavity specimen collected RAHT, nasopharyngeal swab RT-PCR.Sensitivity STANDARD Q Ag Home Test (SD Biosensor, Korea), RT-PCR, 94.94% (75/79) (95% [confidence interval] CI, 87.54%-98.60%), specificity 100%. Sensitivity significantly higher symptomatic (98.00%) than asymptomatic (89.66%) (p-value = 0.03). There no difference sensitivity according (100% 0-2 96.97% 3-5 days, respectively) 1.00). The RAHT detected all 51 whose Ct values ≤25 (100%), whereas 73.33% (11/15) among >25 0.01).The showed excellent COVID-19-confirmed cases, those symptoms. decrease when value is over 25, indicating screening may be useful during early phase onset, viral numbers are it more transmissible.

Language: Английский

Citations

14

Evaluation of the T cell and B cell response following the administration of COVID-19 vaccines in Korea DOI Creative Commons
Kristin Widyasari, Jieun Jang, Seung Jun Lee

et al.

Journal of Microbiology Immunology and Infection, Journal Year: 2022, Volume and Issue: 55(6), P. 1013 - 1024

Published: Sept. 28, 2022

The coronavirus disease (COVID-19) has been a worldwide concern since 2019. Vaccines are predicted to be crucial in preventing further outbreaks. development and kinetics of immune responses determine the efficacy COVID-19 vaccines.We measured interferon-gamma (IFN-γ) levels upon administering homologous adenovirus vector-based (ChAdOx1-S [AZ], Ad26.COV2.S [JAN]), mRNA-based (BNT162b2 [PF]; mRNA-1273 [MO]), heterologous (AZ/PF) vaccines healthy Korean individuals using two IFN-γ release assays: Covi-FERON ELISA T-SPOT Discovery SARS-CoV-2 assay. B cell were evaluated by assessing production neutralizing antibodies surrogate virus neutralization response among vaccine groups was compared after adjusting vaccination dose interactions between each group.AZ triggered highest T first but showed instability second. PF MO yielded stable higher increments AZ. than PF. JAN at lower other vaccines. booster significant increases is therefore needed protect against given possibility waning responses.Administering doses mRNA provides most effective results administered triggering specific individuals. Administration demonstrated increase may provide longer protection SARS-CoV-2.

Language: Английский

Citations

11

Nasal swab is a good alternative sample for detecting SARS-CoV-2 with rapid antigen test: A meta-analysis DOI Creative Commons

Jia‐Wen Xie,

Ya‐Wen Zheng,

Mao Wang

et al.

Travel Medicine and Infectious Disease, Journal Year: 2023, Volume and Issue: 52, P. 102548 - 102548

Published: Feb. 9, 2023

We aim to determine if nasal samples have equivalent detection sensitivity nasopharyngeal swabs for RAT and evaluate the diagnostic accuracy of with RAT.

Language: Английский

Citations

5

Performance Evaluation of STANDARD Q COVID/FLU Ag Combo for Detection of SARS-CoV-2 and Influenza A/B DOI Creative Commons
Kristin Widyasari, Soomin Kim, Sun‐Joo Kim

et al.

Diagnostics, Journal Year: 2022, Volume and Issue: 13(1), P. 32 - 32

Published: Dec. 22, 2022

We evaluated the performance of STANDARD Q COVID/FLU Ag Combo test (Q combo test) for detection SARS-CoV-2, influenza A, and B using a single point-of-care device compared with real-time PCR. A total 408 individuals, 55 positives 90 68 B, 195 negatives all viruses, participated. The demonstrated high level sensitivity 92.73% specificity 99.49% SARS-CoV-2. When number days from symptom onset (DSO) was restricted to 0 < DSO ≤ 6, detect SARS-CoV-2 100%, when Ct value RdRp ≤20, 93.10%. results also 92.22% 100% 91.18%, B. agreement analysis RT-PCR excellent outcomes, making it useful efficient

Language: Английский

Citations

8

The diagnostic performance evaluation of Panbio and STANDARD Q coronavirus disease 2019 antigen tests against real-time polymerase chain reaction in southern Ethiopia DOI Creative Commons

Elias Tamene,

Alemitu Beyene,

Hanibale Atsbeha

et al.

Scientific Reports, Journal Year: 2024, Volume and Issue: 14(1)

Published: Feb. 24, 2024

Abstract The coronavirus disease 2019 (COVID-19) pandemic has created a public health crisis . This study aimed to evaluate the diagnostic performance of Panbio and STANDARD Q COVID-19 antigen rapid tests (RDTs) against real-time polymerase chain reaction (RT-PCR) at one largest hospitals in southern Ethiopia. Nasopharyngeal samples, which were collected during from individuals suspected stored − 70 °C, analyzed June July 2022. was evaluated 200 randomly selected nasopharyngeal samples (100 positives 100 negatives for severe acute respiratory syndrome 2 by RT-PCR). test using positive 50 negative samples. respective sensitivity, specificity, predictive value values 88%, 99%, 98.9% 89.2% 91%, 98%, 84.5%, test. kappa 0.87 0.86 Based on findings presented here, RDTs could be utilized as an alternative conventional RT-PCR when it is challenging diagnose owing lack time, skilled lab personnel, or suitable equipment electricity.

Language: Английский

Citations

1

Rapid Antigen Tests during the COVID-19 Era in Korea and Their Implementation as a Detection Tool for Other Infectious Diseases DOI Creative Commons
Kristin Widyasari, Sun‐Joo Kim

Bioengineering, Journal Year: 2023, Volume and Issue: 10(3), P. 322 - 322

Published: March 3, 2023

Rapid antigen tests (RATs) are diagnostic tools developed to specifically detect a certain protein of infectious agents (viruses, bacteria, or parasites). RATs easily accessible due their rapidity and simplicity. During the COVID-19 pandemic, have been widely used in detecting presence specific SARS-CoV-2 respiratory samples from suspected individuals. Here, authors review application as detection for COVID-19, particularly Korea, well several other diseases. To address these issues, we present general knowledge on design that adopt lateral flow immunoassay analyte (antigen). The then discuss clinical utilization authorized amidst battle against pandemic Korea role comparison with methods. We also implementation other, non-COVID-19 diseases, challenges may arise during application, limitations tools, possible problem solving those maximize performance avoiding any misinterpretation test result.

Language: Английский

Citations

3

Update of European Society of Clinical Microbiology and Infectious Diseases coronavirus disease 2019 guidelines: diagnostic testing for severe acute respiratory syndrome coronavirus 2 DOI Creative Commons
Paraskevi C. Fragkou, Giulia De Angelis, Giulia Menchinelli

et al.

Clinical Microbiology and Infection, Journal Year: 2023, Volume and Issue: 29(7), P. 876 - 886

Published: April 23, 2023

Language: Английский

Citations

3