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currently available, what circumstances warrant their use,
and how to interpret and act on the results. This document
will also help clinicians to have an understanding of
testing methodologies, validation processes, and the
regulatory environment necessary to assess new tests as
they become available.

Acknowledgements
HM would like to give special thanks to DeAunne Denmark, MD, PhD, for the
excellent discussions, feedback, and literature reviews and James Constantini and
IFM for support in creating the graphics. We would like to thank the Institute for
Functional Medicine (IFM) CEO, Amy R. Mack, the IFM COVID-19 Task Force,
members of the IFM staff, and consultants working with IFM for their contributions
to this document.

References
1. Petherick A. Developing antibody tests for SARS-CoV-2. Lancet. 2020;395(10230):1101-
1102. doi:10.1016/S0140-6736(20)30788-1
2. Patel R, Babady E, Theel ES, et al. Report from the American Society for Microbiology
COVID-19 International Summit, 23 March 2020: value of diagnostic testing for SARS-
CoV-2/COVID-19. mBio. 2020;11(2):e00722-20. doi:10.1128/mBio.00722-20
3. Wölfel R, Corman VM, Guggemos W, et al. Virological assessment of hospitalized patients
with COVID-2019. Nature. Published online April 1, 2020. doi:10.1038/s41586-020-
2196-x
4. Lou B, Li T, Zheng S, et al. Serology characteristics of SARS-CoV-2 infection since the
exposure and post symptoms onset. medRxiv. Published online March 27, 2020.
doi:10.1101/2020.03.23.20041707
5. Zhao J, Yuan Q, Wang H, et al. Antibody responses to SARS-CoV-2 in patients of novel
coronavirus disease 2019. Clin Infect Dis. Published online March 28, 2020. doi:10.1093/
cid/ciaa344
6. Wu F, Wang A, Liu M, et.al. Neutralizing antibody responses to SARS-CoV-2 in a COVID-
19 recovered patient cohort and their implications. medRxiv. Published online April 20,
2020. doi:10.1101/2020.03.30.20047365
7. To KK, Tsang OT, Leung WS, et al. Temporal profiles of viral load in posterior
oropharyngeal saliva samples and serum antibody responses during infection by SARS-
CoV-2: an observational cohort study. Lancet Infect Dis. Published online March 23, 2020.
doi:10.1016/S1473-3099(20)30196-1
8. Guo L, Ren L, Yang S, et al. Profiling early humoral response to diagnose novel coronavirus
disease (COVID-19). Clin Infect Dis. Published online March 21, 2020. doi:10.1093/cid/
ciaa310
9. Chang D, Mo G, Yuan X, et al. Time kinetics of viral clearance and resolution of symptoms
in novel coronavirus infection. Am J Respir Crit Care Med. Published online March 23,
2020. doi:10.1164/rccm.202003-0524LE
10. Okba NMA, Müller MA, Li W, et al. Severe acute respiratory syndrome coronavirus 2–
specific antibody responses in coronavirus disease 2019 patients. Emerg Infect Dis.
2020;26(7). doi:10.3201/eid2607.200841
11. Sheridan C. Fast, portable tests come online to curb coronavirus pandemic. Nat Biotechnol.
Published online March 23, 2020. doi:10.1038/d41587-020-00010-2
12. Broughton JP, Deng X, Yu G, et al. CRISPR-Cas12-based detection of SARS-
CoV-2. Nat Biotechnol. Published online April 16, 2020. doi:10.1038/s41587-020-0513-4
13. Spartan COVID-19 test: rapid identification of the COVID-19 virus. Spartan. Published
2020. Accessed April 21, 2020. https://www.spartanbio.com/products/medical/covid-19/
14. Woelfel R, Corman VM, Guggemos W, et al. Clinical presentation and virological assessment
of hospitalized cases of coronavirus disease 2019 in a travel-associated transmission cluster.
medRxiv. Published online March 8, 2020. doi:10.1101/2020.03.05.20030502
15. Yang Y, Yang M, Shen C, et al. Evaluating the accuracy of different respiratory specimens
in the laboratory diagnosis and monitoring the viral shedding of 2019-nCoV infections.
medRxiv. Published online February 17, 2020. doi:10.1101/2020.02.11.20021493
16. Lippi G, Simundic AM, Plebani M. Potential preanalytical and analytical vulnerabilities in
the laboratory diagnosis of coronavirus disease 2019 (COVID-19). Clin Chem Lab Med.
Published online March 16, 2020. doi:10.1515/cclm-2020-0285
17. Zhang W, Du RH, Li B, et al. Molecular and serological investigation of 2019-nCoV
infected patients: implication of multiple shedding routes. Emerg Microbes Infect.
2020;9(1):386-389. doi:10.1080/22221751.2020.1729071
18. Li ZN, Lin SC, Carney PJ, et al. IgM, IgG, and IgA antibody responses to influenza
A(H1N1)pdm09 hemagglutinin in infected persons during the first wave of the 2009
pandemic in the United States. Clin Vaccine Immunol. 2014;21(8):1054-1060. doi:10.1128/
CVI.00129-14
19. Palomaki GE, Haddow JE. Confusion between analytic validity and clinical validity. Am
J Obstet Gynecol. 2016;215(4):533-534. doi:10.1016/j.ajog.2016.06.008
20. Bao L, Deng W, Gao H, et al. Reinfection could not occur in SARS-CoV-2 infected rhesus
macaques. bioRxiv. Published online March 14, 2020. doi:10.1101/2020.03.13.990226

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