Dataset Information

Evaluation of serological lateral flow assays for severe acute respiratory syndrome coronavirus-2.

ABSTRACT:

Background

COVID-19 has resulted in significant morbidity and mortality worldwide. Lateral flow assays can detect anti-Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) antibodies to monitor transmission. However, standardized evaluation of their accuracy and tools to aid in interpreting results are needed.

Methods

We evaluated 20 IgG and IgM assays selected from available tests in April 2020. We evaluated the assays' performance using 56 pre-pandemic negative and 56 SARS-CoV-2-positive plasma samples, collected 10-40 days after symptom onset, confirmed by a molecular test and analyzed by an ultra-sensitive immunoassay. Finally, we developed a user-friendly web app to extrapolate the positive predictive values based on their accuracy and local prevalence.

Results

Combined IgG + IgM sensitivities ranged from 33.9 to 94.6%, while combined specificities ranged from 92.6 to 100%. The highest sensitivities were detected in Lumiquick for IgG (98.2%), BioHit for both IgM (96.4%), and combined IgG + IgM sensitivity (94.6%). Furthermore, 11 LFAs and 8 LFAs showed perfect specificity for IgG and IgM, respectively, with 15 LFAs showing perfect combined IgG + IgM specificity. Lumiquick had the lowest estimated limit-of-detection (LOD) (0.1 μg/mL), followed by a similar LOD of 1.5 μg/mL for CareHealth, Cellex, KHB, and Vivachek.

Conclusion

We provide a public resource of the accuracy of select lateral flow assays with potential for home testing. The cost-effectiveness, scalable manufacturing process, and suitability for self-testing makes LFAs an attractive option for monitoring disease prevalence and assessing vaccine responsiveness. Our web tool provides an easy-to-use interface to demonstrate the impact of prevalence and test accuracy on the positive predictive values.

SUBMITTER: Trombetta BA

PROVIDER: S-EPMC8206878 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature

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Publications

Evaluation of serological lateral flow assays for severe acute respiratory syndrome coronavirus-2.

Trombetta Bianca A BA Kandigian Savannah E SE Kitchen Robert R RR Grauwet Korneel K Webb Pia Kivisäkk PK Miller Glenn A GA Jennings Charles G CG Jain Sejal S Miller Samara S Kuo Yikai Y Sweeney Thadryan T Gilboa Tal T Norman Maia M Simmons Daimon P DP Ramirez Christopher E CE Bedard Melissa M Fink Catherine C Ko Jina J De León Peralta Esmarline J EJ Watts Gerald G Gomez-Rivas Emma E Davis Vannessa V Barilla Rocky M RM Wang Jianing J Cunin Pierre P Bates Samuel S Morrison-Smith Chevaun C Nicholson Benjamin B Wong Edmond E El-Mufti Leena L Kann Michael M Bolling Anna A Fortin Brooke B Ventresca Hayden H Zhou Wen W Pardo Santiago S Kwock Megan M Hazra Aditi A Cheng Leo L Ahmad Q Rushdy QR Toombs James A JA Larson Rebecca R Pleskow Haley H Luo Nell Meosky NM Samaha Christina C Pandya Unnati M UM De Silva Pushpamali P Zhou Sally S Ganhadeiro Zakary Z Yohannes Sara S Gay Rakiesha R Slavik Jacqueline J Mukerji Shibani S SS Jarolim Petr P Walt David R DR Carlyle Becky C BC Ritterhouse Lauren L LL Suliman Sara S

BMC infectious diseases 20210616 1

<h4>Background</h4>COVID-19 has resulted in significant morbidity and mortality worldwide. Lateral flow assays can detect anti-Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) antibodies to monitor transmission. However, standardized evaluation of their accuracy and tools to aid in interpreting results are needed.<h4>Methods</h4>We evaluated 20 IgG and IgM assays selected from available tests in April 2020. We evaluated the assays' performance using 56 pre-pandemic negative and 56 SA ...[more]

PMID: 34134647

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Project description:BackgroundDisinfection is one of the most effective ways to block the rapid transmission of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). Due to the prolonged coronavirus disease 2019 (COVID-19) pandemic, disinfectants have become crucial to prevent person-to-person transmission and decontaminate hands, clothes, facilities and equipment. However, there is a lack of accurate information on the virucidal activity of commercial disinfectants.AimTo evaluate the virucidal efficacy of 72 commercially available disinfectants constituting 16 types of ingredients against SARS-CoV-2.MethodsSARS-CoV-2 was tested with various concentrations of disinfectants at indicated exposure time points as recommended by the manufacturers. The 50% tissue culture infectious dose assay was used to calculate virus titre, and trypan blue staining and CCK-8 were used to assess cell viability after 3-5 days of SARS-CoV-2 infection.FindingsThis study found that disinfectants based on 83% ethanol, 60% propanol/ethanol, 0.00108-0.0011% sodium dichloroisocyanurate and 0.497% potassium peroxymonosulfate inactivated SARS-CoV-2 effectively and safely. Although disinfectants based on 0.05-0.4% benzalkonium chloride (BAC), 0.02-0.07% quaternary ammonium compound (QAC; 1:1), 0.4% BAC/didecyldimethylammonium chloride (DDAC), 0.28% benzethonium chloride concentrate/2-propanol, 0.0205-0.14% DDAC/polyhexamethylene biguanide hydrochloride (PHMB) and 0.5% hydrogen peroxide inactivated SARS-CoV-2 effectively, they exhibited cytotoxicity. Conversely, disinfectants based on 0.04-4% QAC (2:3), 0.00625% BAC/DDAC/PHMB, and 0.0205-0.14% and 0.0173% peracetic acid showed approximately 50% virucidal efficacy with no cytotoxicity. Citric acid (0.4%) did not inactivate SARS-CoV-2.ConclusionThese results indicate that most commercially available disinfectants exert a disinfectant effect against SARS-CoV-2. However, re-evaluation of the effective concentration and exposure time of certain disinfectants is needed, especially citric acid and peracetic acid.

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Dataset Information

Evaluation of serological lateral flow assays for severe acute respiratory syndrome coronavirus-2.

Background

Methods

Results

Conclusion

Publications

Evaluation of serological lateral flow assays for severe acute respiratory syndrome coronavirus-2.

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