Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Jun 2;3(6):e0001555.
doi: 10.1371/journal.pgph.0001555. eCollection 2023.

Diagnostic performance of four lateral flow immunoassays for COVID-19 antibodies in Peruvian population

Rodrigo Calderon-Flores  1 , Guillermo Caceres-Cardenas  1 , Karla Alí  1 , Margaretha De Vos  2 , Devy Emperador  2 , Tatiana Cáceres  1 , Anika Eca  1 , Luz Villa-Castillo  1 , Audrey Albertini  2 , Jilian A Sacks  2 , Cesar Ugarte-Gil  1   3
Affiliations

Diagnostic performance of four lateral flow immunoassays for COVID-19 antibodies in Peruvian population

Rodrigo Calderon-Flores et al. PLOS Glob Public Health. .

Abstract

Serological assays have been used in seroprevalence studies to inform the dynamics of COVID-19. Lateral flow immunoassay (LFIA) tests are a very practical technology to use for this objective; however, one of their challenges may be variable diagnostic performance. Given the numerous available LFIA tests, evaluation of their accuracy is critical before real-world implementation. We performed a retrospective diagnostic evaluation study to independently determine the diagnostic accuracy of 4 different antibody-detection LFIA tests: Now Check (Bionote), CareStart (Access bio), Covid-19 BSS (Biosynex) and OnSite (CTK Biotech). The sample panel was comprised of specimens collected and stored in biobanks; specifically, specimens that were RT-PCR positive for SARS-CoV-2 collected at various times throughout the COVID-19 disease course and those that were collected before the pandemic, during 2018 or earlier, from individuals with upper respiratory symptoms but were negative for tuberculosis. Clinical performance (sensitivity and specificity) was analyzed overall, and subset across individual antibody isotypes, and days from symptoms onset. A very high specificity (98% - 100%) was found for all four tests. Overall sensitivity was variable, ranging from 29% [95% CI: 21%-39%] to 64% [95% CI: 54%-73%]. When considering detection of IgM only, the highest sensitivity was 42% [95% CI: 32%-52%], compared to 57% [95% CI: 47%-66%] for IgG only. When the analysis was restricted to at least 15 days since symptom onset, across any isotype, the sensitivity reached 90% for all four brands. All four LFIA tests proved effective for identifying COVID-19 antibodies when two conditions were met: 1) at least 15 days have elapsed since symptom onset and 2) a sample is considered positive when either IgM or IgG is present. With these considerations, the use of this assays could help in seroprevalence studies or further exploration of its potential uses.

PubMed Disclaimer

Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. Diagnostic accuracy of each antibody test and stratified by immunoglobulin antibody target and time since symptom onset.
TP: True positive, FP: False positive, TN: True negative, FN: False negative. IGG: detection of IgG line only; IGMorIGG: detection of IgG or IgM line; IGM: detection of IgM line only.
See this image and copyright information in PMC

Similar articles

See all similar articles

References

    1. World Health Organization. WHO Coronavirus (COVID-19) Dashboard [Internet]. 2022. [cited 25 Oct 2022]. Available from: https://covid19.who.int
    1. Kevadiya BD, Machhi J, Herskovitz J, Oleynikov MD, Blomberg WR, Bajwa N, et al.. Diagnostics for SARS-CoV-2 infections. Nat Mater [Internet]. 2021. May;20(5):593–605. doi: 10.1038/s41563-020-00906-z - DOI - PMC - PubMed
    1. Peeling RW, Olliaro PL, Boeras DI, Fongwen N. Scaling up COVID-19 rapid antigen tests: promises and challenges. Lancet Infect Dis [Internet]. 2021. Sep;21(9):e290–5. doi: 10.1016/S1473-3099(21)00048-7 - DOI - PMC - PubMed
    1. Cheng ZJ, Li B, Zhan Z, Zhao Z, Xue M, Zheng P, et al.. Clinical Application of Antibody Immunity Against SARS-CoV-2: Comprehensive Review on Immunoassay and Immunotherapy. Clin Rev Allergy Immunol [Internet]. 2022. Jan 15. doi: 10.1007/s12016-021-08912-y - DOI - PMC - PubMed
    1. Robbiani DF, Gaebler C, Muecksch F, Lorenzi JCC, Wang Z, Cho A, et al.. Convergent antibody responses to SARS-CoV-2 in convalescent individuals. Nature [Internet]. 2020. Aug;584(7821):437–42. doi: 10.1038/s41586-020-2456-9 - DOI - PMC - PubMed

Grants and funding

The independent performance evaluation studies for COVID-19 diagnostic tests were funded as part of FIND's work as co-convener of the diagnostics pillar of the Access to COVID-19 Tools (ACT) Accelerator.

LinkOut - more resources