Abstract

Accurate surveillance of coronavirus disease 2019 (COVID-19) incidence requires large-scale testing of the population. Current testing methods require in-person collection of biospecimens by a healthcare worker, limiting access of individuals who do not have access to testing facilities while placing both patients and healthcare workers at risk of exposure to infection. We report the development and validation of a at-home finger-prick dried blood spot collection kit and an analysis method. We demonstrated 100% sensitivity and specificity using at-home collected specimens across the US. Such methods may facilitate the conduct of unbiased serosurveys within hard to reach populations and help reduce the sample collection burden of serological testing on both health care systems and individuals alike.

Highlights

  • Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), formerly known as 2019-nCoV, is an enveloped, single-stranded RNA virus in the family Coronaviridae, genus Betacoronavirus[1,2,3]

  • While direct detection of the virus by RNA or antigen assays remains the standard for confirming acute SARS-CoV-2 infection, serological antibody testing is of increasing importance for many r­ easons[4,5,6,7,8]

  • The COVID-19 patients were eligible to participate in the study if they presented with COVID-19 symptoms and were confirmed positive by either RT-PCR for SARS-CoV-2 RNA and/or a validated serum/plasma serological tests for SARS-CoV-2 antibodies

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Summary

Introduction

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), formerly known as 2019-nCoV, is an enveloped, single-stranded RNA virus in the family Coronaviridae, genus Betacoronavirus[1,2,3]. While direct detection of the virus by RNA or antigen assays remains the standard for confirming acute SARS-CoV-2 infection, serological antibody testing is of increasing importance for many r­ easons[4,5,6,7,8]. All currently approved serological tests require blood specimens collected in-person by a healthcare worker either through phlebotomy or finger-prick. We report the development of an at-home finger-prick dried blood spot collection kit and an accompanying laboratory test to elute and accurately detect antibodies in this convenient sample type with 100% concordance to their clinical status. We created standardized dried blood spot collection kits for reciprocal mailing to and from the homes of potential participants. This type of home-to-lab sourced samples can Scientific Reports | (2020) 10:20188

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