Your browser doesn't support javascript.
Evaluation of serological lateral flow assays for severe acute respiratory syndrome coronavirus-2.
Trombetta, Bianca A; Kandigian, Savannah E; Kitchen, Robert R; Grauwet, Korneel; Webb, Pia Kivisäkk; Miller, Glenn A; Jennings, Charles G; Jain, Sejal; Miller, Samara; Kuo, Yikai; Sweeney, Thadryan; Gilboa, Tal; Norman, Maia; Simmons, Daimon P; Ramirez, Christopher E; Bedard, Melissa; Fink, Catherine; Ko, Jina; De León Peralta, Esmarline J; Watts, Gerald; Gomez-Rivas, Emma; Davis, Vannessa; Barilla, Rocky M; Wang, Jianing; Cunin, Pierre; Bates, Samuel; Morrison-Smith, Chevaun; Nicholson, Benjamin; Wong, Edmond; El-Mufti, Leena; Kann, Michael; Bolling, Anna; Fortin, Brooke; Ventresca, Hayden; Zhou, Wen; Pardo, Santiago; Kwock, Megan; Hazra, Aditi; Cheng, Leo; Ahmad, Q Rushdy; Toombs, James A; Larson, Rebecca; Pleskow, Haley; Luo, Nell Meosky; Samaha, Christina; Pandya, Unnati M; De Silva, Pushpamali; Zhou, Sally; Ganhadeiro, Zakary; Yohannes, Sara.
  • Trombetta BA; Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Charlestown, Boston, MA, USA.
  • Kandigian SE; Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Charlestown, Boston, MA, USA.
  • Kitchen RR; Department of Medicine, Harvard Medical School, Boston, MA, USA.
  • Grauwet K; Mass General Brigham Innovation, Boston, MA, USA.
  • Webb PK; Cardiology Division, Massachusetts General Hospital, Charlestown, MA, USA.
  • Miller GA; Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Charlestown, Boston, MA, USA.
  • Jennings CG; Department of Medicine, Harvard Medical School, Boston, MA, USA.
  • Jain S; Mass General Brigham Innovation, Boston, MA, USA.
  • Miller S; Cardiology Division, Massachusetts General Hospital, Charlestown, MA, USA.
  • Kuo Y; Department of Neurosurgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
  • Sweeney T; Department of Medical Oncology and Center for Cancer-Genome Discovery, Dana-Farber Cancer Institute, Boston, MA, USA.
  • Gilboa T; Department of Pathology, Harvard Medical School, Boston, MA, USA.
  • Norman M; Department of Medicine, Harvard Medical School, Boston, MA, USA.
  • Simmons DP; Center for Regenerative Medicine, Massachusetts General Hospital, Boston, MA, USA.
  • Ramirez CE; Harvard Stem Cell Institute, Cambridge, MA, USA.
  • Bedard M; Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.
  • Fink C; Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Charlestown, Boston, MA, USA.
  • Ko J; Cardiology Division, Massachusetts General Hospital, Charlestown, MA, USA.
  • De León Peralta EJ; Cardiology Division, Massachusetts General Hospital, Charlestown, MA, USA.
  • Watts G; Wyss Institute for Biologically Inspired Engineering, Harvard University, Boston, MA, USA.
  • Gomez-Rivas E; Department of Pathology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
  • Davis V; Wyss Institute for Biologically Inspired Engineering, Harvard University, Boston, MA, USA.
  • Barilla RM; Department of Pathology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
  • Wang J; Sackler School of Biomedical Sciences, Tufts University School of Medicine, Boston, MA, USA.
  • Cunin P; Division of Rheumatology, Inflammation and Immunity, Brigham and Women's Hospital, Boston, MA, USA.
  • Bates S; Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Charlestown, Boston, MA, USA.
  • Morrison-Smith C; Division of Rheumatology, Inflammation and Immunity, Brigham and Women's Hospital, Boston, MA, USA.
  • Nicholson B; Medical Diagnostic Technology Evaluation, LLC, Carlisle, MA, USA.
  • Wong E; Wyss Institute for Biologically Inspired Engineering, Harvard University, Boston, MA, USA.
  • El-Mufti L; Center for Systems Biology, Massachusetts General Hospital, Boston, MA, USA.
  • Kann M; Department of Pathology, Massachusetts General Hospital, Boston, MA, USA.
  • Bolling A; Wellman Center for Photomedicine, Massachusetts General Research Institute, Boston, MA, USA.
  • Fortin B; Department of Dermatology, Massachusetts General Hospital, Boston, MA, USA.
  • Ventresca H; Division of Rheumatology, Inflammation and Immunity, Brigham and Women's Hospital, Boston, MA, USA.
  • Zhou W; Division of Rheumatology, Inflammation and Immunity, Brigham and Women's Hospital, Boston, MA, USA.
  • Pardo S; Department of Pathology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
  • Kwock M; Evergrande Center for Immunologic Diseases, Brigham and Women's Hospital, Boston, MA, USA.
  • Hazra A; Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.
  • Cheng L; Division of Rheumatology, Inflammation and Immunity, Brigham and Women's Hospital, Boston, MA, USA.
  • Ahmad QR; Functional Genomics Laboratory, Channing Division of Network Medicine, Brigham and Women's Hospital, Boston, MA, USA.
  • Toombs JA; Department of Pathology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
  • Larson R; Center for Cancer Research, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, USA.
  • Pleskow H; Center for Cancer Research, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, USA.
  • Luo NM; Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Charlestown, Boston, MA, USA.
  • Samaha C; Center for Cancer Research, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, USA.
  • Pandya UM; Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Charlestown, Boston, MA, USA.
  • De Silva P; Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Charlestown, Boston, MA, USA.
  • Zhou S; Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.
  • Ganhadeiro Z; Division of Nephrology and Endocrine Unit Department of Medicine, Massachusetts General Hospital, Boston, MA, USA.
  • Yohannes S; Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Charlestown, Boston, MA, USA.
BMC Infect Dis ; 21(1): 580, 2021 Jun 16.
Article in English | MEDLINE | ID: covidwho-1274540
Preprint
This scientific journal article is probably based on a previously available preprint. It has been identified through a machine matching algorithm, human confirmation is still pending.
See preprint
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.
Subject(s)
Keywords
Fulltext
Print
XML
PubMed Links
Search on Google

Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunoglobulin G / Immunoglobulin M / COVID-19 Serological Testing / SARS-CoV-2 / COVID-19 / Antibodies, Viral Type of study: Diagnostic study / Experimental Studies / Observational study / Prognostic study Topics: Vaccines Limits: Adult / Aged / Female / Humans / Male / Middle aged Language: English Journal: BMC Infect Dis Journal subject: Communicable Diseases Year: 2021 Document Type: Article Affiliation country: S12879-021-06257-7

Similar

MEDLINE
LILACS
LIS
Fulltext
Print
XML
PubMed Links
Search on Google

Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunoglobulin G / Immunoglobulin M / COVID-19 Serological Testing / SARS-CoV-2 / COVID-19 / Antibodies, Viral Type of study: Diagnostic study / Experimental Studies / Observational study / Prognostic study Topics: Vaccines Limits: Adult / Aged / Female / Humans / Male / Middle aged Language: English Journal: BMC Infect Dis Journal subject: Communicable Diseases Year: 2021 Document Type: Article Affiliation country: S12879-021-06257-7