COVID-19 TESTING IN THE OUTPATIENT SETTING

Avalon Clinical Advisory Board Recommendations

SUMMARY OF RECOMMENDATIONS

• Based on the current scientific literature, Avalon recommends nucleic acid testing for identifying the presence of SARS-CoV-2, the causative agent of COVID-19, in an individual in an outpatient setting.

• Based on the current scientific literature, Avalon does not recommend the use of host antibody serology testing, including IgG, IgA, and/or IgM, to diagnose a current SARS-CoV-2 infection in an outpatient setting and/or to screen asymptomatic individuals and/or to determine the immunity at this time.

• Based on the current scientific literature, Avalon does not recommend the use of antigen-detecting rapid diagnostic tests to guide patient care in the outpatient setting at this time.

BACKGROUND

Coronavirus disease 2019, or COVID-19, was first reported in Wuhan, China, in late 2019. It is caused from an infection by a novel b-coronavirus Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). To date, it is reported that approximately 80% of individuals infected with SARS-CoV-2 exhibit mild-to-no symptoms; however, “14% have serious and 5% have critical illness”2. The virus primarily affects the respiratory system, and symptomatic patients often present lower respiratory tract infection-related symptoms, including fever, dry cough, and dyspnea.

Risk factors for severe illness include medical comorbidities—such as cardiovascular disease, diabetes mellitus, hypertension, cancer, obesity, and chronic kidney disease—as well as adults with advanced age; however, it is important to note that severe illness can occur in individuals of any age group3,4. Almost 20% of COVID-19 patients also present severe coagulation abnormalities5. As of April 25, 2020, the World Health Organization reported more than 2,700,000 confirmed cases worldwide with almost 190,000 confirmed deaths in 213 different countries6.

In order to properly diagnose suspected cases or to even track potential outbreak progression, accurate testing methods are required. Recent shortages of testing during the COVID-19 pandemic has encouraged the development of multiple tests. Here, Avalon has outlined the following diagnostic testing methodologies for the current COVID-19 pandemic.

RT-PCR (REVERSE TRANSCRIPTION-POLYMERASE CHAIN REACTION)

Coronaviruses are RNA viruses so during the initial phase of the infection the relative concentration of the viral RNA increases (Figure 1). RT-PCR is a powerful molecular technique that uses RNA as its initial template to make complimentary DNA and then to make many copies of that DNA. RT-PCR, when used with appropriate primers targeting the SARS-CoV-2 RNA, is used to diagnose an acute infection.

The CDC has released standard primers for use in RT-PCR tests for the presence of SARS-CoV-2 RNA for research use, and primers or probes that receive an EUA label may also be used with the CDC’s RT-PCR Diagnostic Panel7. As depicted in Figure 1, the concentration of viral RNA decreases as the immune system fights the infection, and very low or undetectable viral RNAlevels are typically present after an individual has recovered. Consequently, RT-PCR cannot be used to screen for a past infection. Another limitation to RT-PCR is that it does require specific instrumentation, a thermocycler, and, therefore, is less amenable as a rapid, point-of-care test.

 

Figure 1: General time course of a viral infection, such as SARS-CoV-2. This is for illustrative purposes and should not be used as a primary reference or for diagnostic purposes. The original content can be found within the references 1.

Many studies have been performed to date to evaluate the analytical performance of RT-PCR. One study, using a high-throughput platform for example, reported a limit of detection (LoD) of 689.3 copies/mL and 275.72 copies per reaction at 95% detection probability8. The WHO diagnostic RT-PCR test utilizes two genes--the E gene as the molecular target (where the limit is 3.9 copies per reaction) and the RdRp gene as the molecular target (limit of 3.6 copies per reaction)9. One recent study reported possible in vitro cross-reactivity between the RdRp- based method used predominantly in European labs with SARS-CoV in cell culture10.

SARS- CoV is the coronavirus that caused the initial SARS (Severe Acute Respiratory Syndrome) outbreak in 2003 that resulted in over 8000 cases in 26 different countries. Since 2003, only four limited reoccurrences have been reported according to the WHO—three incidences are due to laboratory accidents (in Taipei and Singapore) and one incident of undetermined source in China11.

The likelihood of either a co-infection of SARS-CoV and SARS-CoV-2 or a concurrent outbreak of both viruses at this time is small. The CDC diagnostic panel test does not target the RdRp gene; it consists of two primer/probe sets of the N gene and one primer/probe set for human RNase P gene (RP) as the control. The CDC diagnostic panel has a reported limit of 1.0 – 3.2 copies/µL.9,12

Reports of initial negative RT-PCR results in individuals who later develop symptomatic COVID-19 have been published, but this may occur if the sample was not properly collected or if it was taken from the patient early in the infection during the initial incubation period of SARS-CoV-2, which is approximately 6 days (interquartile range [IQR, 2 – 11 days]9,13. Consequently, it is important to remember that “Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information14.”

HOST ANTIBODY TESTING (SEROLOGY)

The COVID-19 illness begins with an initial infection by SARS-CoV2. This invasion by the virus initiates an immune response by the host where the host’s immune cells produced immunoglobulins, such as IgM, IgA, and IgG, that can target the invading virus. However, a lag in time between the initial infection by the virus and the production of immunoglobulins occurs (Figure 1)1.

Typically, several days after the initial onset of symptoms, the first IgM immunoglobulins are produced to combat the viral infection. IgA (not shown in figure) are immunoglobulins secreted to protect predominantly the mucosal linings of the gastrointestinal, respiratory, and genitourinary tracts15, and IgA subclasses typically have a half-life of 4 – 6 days16. Finally, IgG, which are the long-term immunoglobulins found within body fluids that fight bacterial and viral infections, are produced and IgM production wanes. Some limited studies have indicated that some individuals may initially concurrently produce IgM and IgG antibodies, but additional research is needed17.

Serological host antibody tests can detect the presence of IgM and IgG antibodies that an individual has developed in response to an infection—in this case, a SARS-CoV-2 viral infection. The test may report total antibodies present, meaning either it does not distinguish between IgG and IgM or that it is reporting the sum of IgG and IgM. This is sometimes referred to as “total antibody testing”. On the other hand, the test may be specific for one antibody, such as IgG or IgM, or the test may claim to accurately distinguish between the antibodies.

Antibody testing has many potential uses. Ideally, the use of an accurate, reliable antibody test could possibly show whether someone has previously been exposed to the virus. This could indicate possible immunity in an individual. Please note that the antibody test is not used as a diagnostic test, meaning it should not be used to diagnose an acute infection.

Since SARS-CoV-2 is a new, emerging virus with little research to date, it is not known for certain how long it takes for the seroconversion to occur or when antibodies start to appear in the blood at high enough concentrations for accurate testing results. A recent study accepted for publication in Clinical Infectious Diseases reports an average of seroconversion time for IgM and IgG at 12 and 14 days, respectively19. A small study (n=34 patients) reports the presence of IgG for at least seven weeks (the duration of the study)20. Another study, however, reports that IgM testing has similar, if not better positive detection rate than PCR 5.5 days after initial onset of symptoms…with a big “catch”—the total window of antibody detection for IgM was only 5 days long21 (See Figure 1).

If the patient was not tested during the detection window, then the individual would not necessarily have a “positive” result for IgM. The authors also report the detection of IgA antibodies (median onset at 5 days after initial symptoms [IQR 3 – 6 days]), and 92.7% of total samples report a positive result for IgA. This same study also reports that IgG detection occurs, on average, fourteen days after initial onset of symptoms21. Another study reports that IgA-based ELISA testing has higher sensitivity than IgG-based ELISA testing, but the IgG-based ELISA testing has higher specificity. The authors recommend IgG-based testing over the IgA-based testing in immunosurveillance studies since IgG has a longer biological half-life22. At least one published study to date has reported that as many as 6.9% of individuals who previously had tested positive with RT-PCR results did not show the presence of antibodies for the length of the study (at least 40 days after the initial onset of symptoms)19.

Ideally, any rapid diagnostic test for the outpatient setting must be accurate and reliable. Current research indicates that the diagnostic window for IgA and IgM is very limited. Some data indicate that host antibody testing can also yield inaccuracies. Also, for IgG testing, the significance of positive results is questionable at the current time. A positive result could indicate a previous infection, assuming the test did not cross-react with any other IgG the host produced in response to one of the four coronaviruses known to cause the common cold in humans, for example.

It is not currently known, however, if the presence of IgG antibodies indicates immunity (or degree thereof) of the host against SARS-CoV-2. The duration of any conferred immunity, or the level of IgG antibodies required to effectively acquire such immunity, are also unknown. Additional research is needed and encouraged.

 

DIAGNOSTIC ANTIGEN DETECTION TESTING (SEROLOGY)

Another possible diagnostic testing methodology is antigen detection testing, which relies upon the direct detection of parts of the virus called “antigens”—in this instance, proteins located on the outside of SARS-CoV-2, such as the spike protein (S) or nucleocapsid protein. These antigen detection tests can be deployed as rapid antigen tests that decrease the turnaround time for results but usually lack specificity23.

One multi-center study, currently a preprint at the time of publication, reports the development of a rapid antigen detection test (RADT) that screens for SARS-CoV-2 by targeting the nucleocapsid protein. This test, when using a nasopharyngeal swab sample, reports a 100% positive agreement with RT-PCR testing24. This study is yet to be published in a peer-reviewed journal, and the test is not FDA- approved as of 04/26/2020.

Another study published recently in ACS Nano reports on the development of a RADT using field-effect transistor (FET)-based biosensing where a graphene sheet for the FET is coated with a specific antibody against the SARS-CoV-2 spike protein. This method can detect the protein in concentrations as low as 1 fg/mL in buffer and has an LOD of 242 copies/mL for a clinical sample (versus 16/mL for a culture medium)25.

To date, the WHO does not recommend the use of antigen-detecting rapid diagnostic tests to guide patient care26, and the FDA has not approved such tests for emergency use authorization status18,27. Additional research is required to show that such testing meets the need for accuracy and reliability as a point-of-care test.

GUIDELINES

World Health Organization 26,28

The World Health Organization (WHO) released a scientific brief with recommendations on the use of point-of-care immunodiagnostic tests for COVID-19 on April 8, 2020. Within the guidelines, they recommend that such testing only be used within research settings at this time until additional evidence is available. WHO specifically does not recommend the use of antigen-detecting rapid diagnostic tests for patient care. These are tests that detect the presence of viral proteins taken from a biological sample obtained from a patient. WHO also does not recommend the use of antibody-detecting rapid diagnostic tests for patient care; however, they do specifically encourage “the continuation of work to establish their usefulness in disease surveillance and epidemiologic research”26.

WHO released a second scientific brief with recommendations concerning immunity passports28 on April 24, 2020. Within the guidelines, WHO states that as of the publication date, “no study has evaluated whether the presence of antibodies to SARS-CoV-2 confers immunity to subsequent infection by this virus in humans.” They go on to note, “Laboratory tests that detect antibodies to SARS-CoV-2 in people, including rapid immunodiagnostic tests, need further validation to determine their accuracy and reliability. Inaccurate immunodiagnostic tests may falsely categorize people in two ways. The first is that they may falsely label people who have been infected as negative, and the second is that people who have not been infected are falsely labelled as positive. Both errors have serious consequences and will affect control efforts. These tests also need to accurately distinguish between past infections from SARS-CoV-2 and those caused by the known set of six human coronaviruses. Four of these viruses cause the common cold and circulate widely. The remaining two are the viruses that cause Middle East Respiratory Syndrome and Severe Acute Respiratory Syndrome. People infected by any one of these viruses may produce antibodies that cross- react with antibodies produced in response to infection with SARS-CoV-2.28

Centers for Disease Control and Prevention (CDC) 29-32

The CDC states that for initial diagnostic testing for COVID-19, “CDC recommends collecting and testing upper respiratory tract specimens (nasopharyngeal swab). CDC also recommends testing lower respiratory tract specimens, if available. For patients who develop a productive cough, sputum should be collected and tested for COVID-19. The induction of sputum is not recommended. For patients for whom it is clinically indicated (e.g., those receiving invasive mechanical ventilation), a lower respiratory tract aspirate or bronchoalveolar lavage sample should be collected and tested as a lower respiratory tract specimen.”

They also state, “Clinicians considering testing of persons with possible COVID-19 should continue to work with their local and state health departments to coordinate testing through public health laboratories, or use COVID-19 diagnostic testing, authorized by the Food and Drug Administration under an Emergency Use Authorization (EUA) through clinical laboratories. Increasing testing capacity will allow clinicians to consider COVID-19 testing for a wider group of symptomatic patients.”29

The CDC issued employer-based guidelines titled Interim Guidance for Businesses and employers to Plan and Respond to Coronavirus Disease 2019 (COVID-19). Within the guidelines, they recommend that symptomatic employees should notify their supervisor and stay home. “Sick employees should follow CDC-recommended steps. Employees should not return to work until the criteria to discontinue home isolation are met, in consultation with healthcare providers and state and local health departments. Employees who are well but who have a sick family member at home with COVID-19 should notify their supervisor and follow CDC recommended precautions.”30

The CDC goes on to state, “Employers should not require a positive COVID-19 test result or a healthcare provider’s note for employees who are sick to validate their illness, qualify for sick leave, or to return to work. Healthcare provider offices and medical facilities may be extremely busy and not able to provide such documentation in a timely manner. Review human resources policies to make sure that policies and practices are consistent with public health recommendations and are consistent with existing state and federal workplace laws (for more information on employer responsibilities, visit the Department of Labor’s and the Equal Employment Opportunity Commission’s websites).”30

The CDC, in a joint interim set of guidelines with OSHA, issued Meat and Poultry Processing Workers and Employers Interim Guidance from CDC and the Occupational Safety and Health Administration (OSHA).31 Within these guidelines, they recommend possible screening and monitoring methods for employers to use due to recent outbreaks within this industry. These include verbal screening, temperatures, and engineering controls (such as physical distancing), but the guidelines are silent on laboratory testing. Within the section addressing when a previously ill (or asymptomatic) employee can return to work, they recommend that the employers should follow the interim guidelines of the CDC titled Discontinuation of Isolation for Persons with COVID-19 Not in Healthcare Settings.31

Within the CDC interim guidelines Discontinuation of Isolation for Persons with COVID-19 Not in Healthcare Settings, the CDC does give a test-based strategy for discontinuing isolation for individuals with COVID-19. “Test-based strategy (simplified from initial protocol) Previous recommendations for a test-based strategy remain applicable; however, a test-based strategy is contingent on the availability of ample testing supplies and laboratory capacity as well as convenient access to testing. For jurisdictions that choose to use a test-based strategy, the recommended protocol has been simplified so that only one swab is needed at every sampling [Note: emphasis is from source material].”32 As of April 30, 2020, these interim guidelines did not address either antibody or direct antigen testing.

National Institutes of Health (NIH) 33

The NIH released COVID-19 treatment guidelines, and within the 04/21/2020 update the addressed laboratory in asymptomatic and presymptomatic individuals.They give a level AIII (Strong recommendation; Expert Opinion) recommendation stating, “The Panel recommends no additional laboratory testing and no specific treatment for persons with suspected or confirmed asymptomatic or presymptomatic SARS-CoV-2 infection (AIII).”33



Occupational Safety and Health Administration (OSHA) 34

In the OSHA guidelines for employers, they classify jobs based on exposure risk to COVID-19 (lower, medium, high, or very high). In general, they recommend following CDC and local health department guidelines. They do state that employers should not require documentation for employees to return to work since healthcare provider offices and medical facilities may be extremely busy during the crisis. For jobs classified at medium exposure risk, administrative controls do include the responsibility of the employer to “communicate the availability of medical screening or other worker health resources (e.g., on-site nurse; telemedicine services).” For jobs classified at high or very high exposure risk, administrative controls include that employers should “consider offering enhanced medical monitoring of workers during COVID-19 outbreaks.” OSHA does not state what the term enhanced medical monitoring entails.


European Centre for Disease Prevention and Control (ECDC) 35

The ECDC in their guidance for laboratory support in the EU/EEA recommends using WHO- recommended testing strategies for the diagnosis and confirmation of COVID-19. They also recommend a positive patient end either isolation at home (or comparable safe place) or hospitalization after clinical improvement and two negative RT-PCR test results (from a respiratory sample) taken at least 24 hours apart at least eight days after the original onset of symptoms35.




Public Health England (PHE) 36,37

The PHE does not recommend the use of rapid tests for the diagnosis of COVID-19 infection in community settings, such as pharmacies, because “there is little information on the accuracy of the tests, or on how a patient’s antibody response develops or changes during COVID-19 infection. It is not known whether either a positive or negative result is reliable.”36 Also, serology tests are performed only if the individual is hospitalized; otherwise, only respiratory tract samples are obtained37.




EVIDENCE-BASED SCIENTIFIC REFERENCES

1. The_Native_Antigen_Company. Why We Need Antigen and Antibody Tests for COVID-19. 2020; https://thenativeantigencompany.com/why-we-need-antigen-and-antibody-tests-for-covid-19/. Accessed 04/21/2020, 2020.

2. IDSA. Infectious Diseases Society of America Guidelines on the Treatment and Management of Patients with COVID-19. 2020; https://www.idsociety.org/practice-guideline/covid-19-guideline- treatment-and-management/. Accessed 04/22/2020, 2020.

3. Yuki K, Fujiogi M, Koutsogiannaki S. COVID-19 pathophysiology: A review. Clin Immunol. 2020:108427.

4. McIntosh K. Coronavirus disease 2019 (COVID-19): Epidemiology, virology, clinical features, diagnosis, and prevention. UpToDate 2020; https://www.uptodate.com/contents/coronavirus- disease-2019-covid-19-epidemiology-virology-clinical-features-diagnosis-and-prevention. Accessed 04/25/2020, 2020.

5. Zhai Z, Li C, Chen Y, et al. Prevention and Treatment of Venous Thromboembolism Associated with Coronavirus Disease 2019 Infection: A Consensus Statement before Guidelines. Thromb Haemost. 2020.

6. WHO. Coronavirus disease (COVID-19) Pandemic. 2020; https://www.who.int/emergencies/diseases/novel-coronavirus-2019. Accessed 04/25/2020, 2020.

7. CDC. Research Use Only 2019-Novel Coronavirus (2019-nCoV) Real-time RT-PCR Primer and Probe Information. 2020; https://www.cdc.gov/coronavirus/2019-ncov/lab/rt-pcr-panel-primer- probes.html. Accessed 04/25/2020, 2020.

8. Pfefferle S, Reucher S, Nörz D, Lütgehetmann M. Evaluation of a quantitative RT-PCR assay for the detection of the emerging coronavirus SARS-CoV-2 using a high throughput system. Euro Surveill. 2020;25(9).

9. 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. 2020.

10. Chan JF, Yip CC, To KK, et al. Improved Molecular Diagnosis of COVID-19 by the Novel, Highly Sensitive and Specific COVID-19-RdRp/Hel Real-Time Reverse Transcription-PCR Assay Validated In Vitro and with Clinical Specimens. J Clin Microbiol. 2020;58(5).

11. WHO. SARS (Severe Acute Respiratory Syndrome). 2020; https://www.who.int/ith/diseases/sars/en/. Accessed 04/26/2020, 2020.

12. CDC. CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel 2020; https://www.fda.gov/media/134922/download. Accessed 04/30/2020, 2020.

13. Backer JA, Klinkenberg D, Wallinga J. Incubation period of 2019 novel coronavirus (2019-nCoV) infections among travellers from Wuhan, China, 20-28 January 2020. Euro Surveill. 2020;25(5).

14. LabCorp. ACCELERATED EMERGENCY USE AUTHORIZATION (EUA) SUMMARY COVID-19 RT-PCR TEST (LABORATORY CORPORATION OF AMERICA). 2020; https://www.fda.gov/media/136151/download. Accessed 04/26/2020, 2020.

15. Woof JM, Kerr MA. The function of immunoglobulin A in immunity. The Journal of Pathology. 2006;208(2):270-282.

16. Morell A, Skvaril F, Noseda G, Barandun S. Metabolic properties of human IgA subclasses. Clin Exp Immunol. 1973;13(4):521-528.

17. Padoan A, Cosma C, Sciacovelli L, Faggian D, Plebani M. Analytical performances of a chemiluminescence immunoassay for SARS-CoV-2 IgM/IgG and antibody kinetics. Clin Chem Lab Med. 2020.

18. FDA. Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency. 2020; https://www.fda.gov/media/135659/download. Accessed 04/21/2020, 2020.

19. Zhao J, Yuan Q, Wang H, et al. Antibody responses to SARS-CoV-2 in patients of novel coronavirus disease 2019. Clinical Infectious Diseases. 2020.

20. Xiao DAT, Gao DC, Zhang DS. Profile of Specific Antibodies to SARS-CoV-2: The First Report. J Infect. 2020.

21. Guo L, Ren L, Yang S, et al. Profiling Early Humoral Response to Diagnose Novel Coronavirus Disease (COVID-19). Clinical Infectious Diseases. 2020.

22. 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).

23. Loeffelholz MJ, Tang Y-W. Laboratory diagnosis of emerging human coronavirus infections – the state of the art. Emerging Microbes & Infections. 2020;9(1):747-756.

24. Diao B, Wen K, Chen J, et al. Diagnosis of Acute Respiratory Syndrome Coronavirus 2 Infection by Detection of Nucleocapsid Protein. medRxiv. 2020:2020.2003.2007.20032524.

25. Seo G, Lee G, Kim MJ, et al. Rapid Detection of COVID-19 Causative Virus (SARS-CoV-2) in Human Nasopharyngeal Swab Specimens Using Field-Effect Transistor-Based Biosensor. ACS Nano. 2020;14(4):5135-5142.

26. WHO. Advice on the use of point-of-care immunodiagnostic tests for COVID-19. 2020; https://www.who.int/news-room/commentaries/detail/advice-on-the-use-of-point-of-care- immunodiagnostic-tests-for-covid-19. Accessed 04/22/2020, 2020.

27. FDA. Emergency Use Authorization. 2020; https://www.fda.gov/emergency-preparedness-and- response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization. Accessed 04/13/2020, 2020.

28. WHO. “Immunity passports” in the context of COVID-19. 2020; https://www.who.int/news- room/commentaries/detail/immunity-passports-in-the-context-of-covid-19. Accessed 04/25/2020, 2020.

29. CDC. Evaluating and Testing Persons for Coronavirus Disease 2019 (COVID-19). 2020; https://www.cdc.gov/coronavirus/2019-nCoV/hcp/clinical-criteria.html. Accessed 04/25/2020, 2020.

30. CDC. Interim Guidance for Businesses and Employers to Plan and Respond to Coronavirus Disease 2019 (COVID-19). 2020; https://www.cdc.gov/coronavirus/2019-ncov/community/guidance- business-response.html. Accessed 04/29/2020, 2020.

31. CDC, OSHA. Meat and Poultry Processing Workers and Employers Interim Guidance from CDC and the Occupational Safety and Health Administration (OSHA). 2020; https://www.cdc.gov/coronavirus/2019-ncov/community/organizations/meat-poultry- processing-workers-employers.html. Accessed 04/30/2020, 2020.

32. CDC. Discontinuation of Isolation for Persons with COVID-19 Not in Healthcare Settings (Interim Guidance). 2020; https://www.cdc.gov/coronavirus/2019-ncov/hcp/disposition-in-home- patients.html. Accessed 04/30/2020, 2020.

33. NIH. COVID-19 Treatment Guidelines. 2020; https://covid19treatmentguidelines.nih.gov/overview/management-of-covid-19/. Accessed 04/25/2020, 2020.

34. OSHA. Guidance on Preparing Workplaces for COVID-19. 2020; https://www.osha.gov/Publications/OSHA3990.pdf. Accessed 04/29/2020, 2020.

35. ECDC. Laboratory support for COVID-19 in the EU/EEA. 2020; https://www.ecdc.europa.eu/en/novel-coronavirus/laboratory-support. Accessed 04/25/2020, 2020.

36. PHE. COVID-19: rapid tests for use in community pharmacies or at home. 2020; https://www.gov.uk/government/publications/covid-19-rapid-tests-for-use-in-community- pharmacies-or-at-home/covid-19-rapid-tests-for-use-in-community-pharmacies-or-at-home. Accessed 04/25/2020, 2020.

37. PHE. COVID-19: laboratory investigations and sample requirements for diagnosis. 2020; https://www.gov.uk/government/publications/wuhan-novel-coronavirus-guidance-for-clinical- diagnostic-laboratories/laboratory-investigations-and-sample-requirements-for-diagnosing-and- monitoring-wn-cov-infection. Accessed 04/25/2020, 2020.

38. NYSDOH. New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel. 2020; https://www.fda.gov/media/135847/download. Accessed 04/27/2020, 2020.

39. Roche_Molecular_Systems_Inc. cobas® SARS-CoV-2. 2020; https://www.fda.gov/media/136049/download. Accessed 04/27/2020, 2020.

40. ThermoFisher_Scientific. TaqPath™ COVID-19 Combo Kit INSTRUCTIONS FOR USE. 2020; https://www.fda.gov/media/136112/download. Accessed 04/27/2020, 2020.

41. Hologic. SARS-CoV-2 Assay (Panther Fusion® System). 2020; https://www.fda.gov/media/136156/download. Accessed 04/27/2020, 2020.

42. Quidel_Corporation. Lyra® SARS-CoV-2 Assay Instructions for Use 2020; https://www.fda.gov/media/136227/download. Accessed 04/27/2020, 2020.

43. Quest_Diagnostics. SARS-CoV-2 RNA, Qualitative Real-Time RT-PCR (Test Code 39433). 2020; https://www.fda.gov/media/136231/download. Accessed 04/27/2020, 2020.

44. Abbott_Molecular. Abbott RealTime SARS-CoV-2. 2020; https://www.fda.gov/media/136258/download. Accessed 04/27/2020, 2020.

45. DiaSorin. Simplexa™ COVID-19 Direct. 2020; https://www.fda.gov/media/136286/download. Accessed 04/24/2020, 2020.

46. GenMark_Dx. ePlex® SARS-CoV-2 Test Assay Manual. 2020; https://www.fda.gov/media/136282/download. Accessed 04/27/2020, 2020.

47. Primerdesign_Ltd. Primerdesign Ltd COVID-19 genesig® Real-Time PCR assay. 2020; https://www.fda.gov/media/136309/download. Accessed 04/27/2020, 2020.

48. Cepheid. Xpert® Xpress SARS-CoV-2. 2020; https://www.fda.gov/media/136315/download. Accessed 04/27/2020, 2020.

49. BioFire_Defense_LLC. BioFire ® COVID-19 Test Instructions for Use. 2020; https://www.fda.gov/media/136353/download. Accessed 04/27/2020, 2020.

50. Mesa_Biotech. Accula™ SARS-Cov-2 Test. 2020; https://www.fda.gov/media/136355/download. Accessed 04/27/2020, 2020.

51. PerkinElmer_Inc. Instructions for PerkinElmer® New Coronavirus Nucleic Acid Detection Kit v 3.0. 2020; https://www.fda.gov/media/136410/download. Accessed 04/27/2020, 2020.

52. Avellino_Lab. ACCELERATED EMERGENCY USE AUTHORIZATION (EUA) SUMMARY AVELLINOCoV2 TEST (AVELLINO LAB USA). 2020; https://www.fda.gov/media/136453/download. Accessed 04/27/2020, 2020.

53. BGI_Genomics. Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2. 2020; https://www.fda.gov/media/136472/download. Accessed 04/27/2020, 2020.

54. Abbott_Diagnostics_Scarborough_Inc. ID NOW COVID-19. 2020; https://www.fda.gov/media/136525/download. Accessed 04/27/2020, 2020.

55. Luminex. NxTAG® CoV Extended Panel Assay Package Insert. 2020; https://www.fda.gov/media/136500/download. Accessed 04/27/2020, 2020.

56. NeuMoDx_Molecular_Inc. NeuMoDx™ SARS-CoV-2 Assay Instructions For Use. 2020; https://www.fda.gov/media/136565/download. Accessed 04/27/2020, 2020.

57. Qiagen_GmbH. QIAstat-Dx® Respiratory SARS-CoV2 Panel Instructions for Use (Handbook). 2020; https://www.fda.gov/media/136571/download. Accessed 04/27/2020, 2020.

58. Yale_New_Haven_Hospital. ACCELERATED EMERGENCY USE AUTHORIZATION (EUA) SUMMARY SARS-CoV2 RT-PCR Assay (Yale New Haven Hospital). 2020; https://www.fda.gov/media/136602/download. Accessed 04/27/2020, 2020.

59. Cellex. Cellex qSARS-CoV-2 IgG/IgM Rapid Test. 2020; https://www.fda.gov/media/136625/download. Accessed 04/27/2020, 2020.

60. Ipsum_Diagnostics_LLC. EMERGENCY USE AUTHORIZATION (EUA) SUMMARY The COV-19 IDx assay (Ipsum Diagnostics, LLC). 2020; https://www.fda.gov/media/136621/download. Accessed 04/27/2020, 2020.

61. Becton_Dickinson_and_Company. BioGX SARS-CoV-2 Reagents for BD MAX™ System. 2020; https://www.fda.gov/media/136653/download. Accessed 04/27/2020, 2020.

62. Scherf U. SARS-CoV-2 RT-PCR test Letter of Inclusion. 2020; https://www.fda.gov/media/136657/download. Accessed 04/27/2020, 2020.

63. Northwestern_Medicine. ACCELERATED EMERGENCY USE AUTHORIZATION (EUA) SUMMARY SARS-CoV-2 ASSAY (NORTHWESTERN MEDICINE). 2020; https://www.fda.gov/media/136669/download. Accessed 04/27/2020, 2020.

64. MGH. ACCELERATED EMERGENCY USE AUTHORIZATION (EUA) SUMMARY SARS-CoV-2 RT-PCR Assay (Massachusetts General Hospital). 2020; https://www.fda.gov/media/136699/download. Accessed 04/27/2020, 2020.

65. Luminex. ARIES® SARS-CoV-2 Assay Package Insert. 2020; https://www.fda.gov/media/136693/download. Accessed 04/27/2020, 2020.

66. ScienCell_Research_Laboratories. ScienCell™ SARS-CoV-2 Coronavirus Real-time RT-PCR (RT- qPCR) Detection Kit. 2020; https://www.fda.gov/media/136691/download. Accessed 04/27/2020, 2020.

67. Co-Diagnostics_Inc. Logix Smart™ Coronavirus Disease 2019 (COVID-19) Kit. 2020; https://www.fda.gov/media/136687/download. Accessed 04/27/2020, 2020.

68. Gnomegen. Gnomegen COVID-19 RT-Digital PCR Detection Kit Instructions for Use. 2020; https://www.fda.gov/media/136738/download. Accessed 04/13/2020, 2020.

69. Viracor. ACCELERATED EMERGENCY USE AUTHORIZATION (EUA) SUMMARY SARS-CoV-2 RT-PCR TEST (Viracor Eurofins Clinical Diagnostics). 2020; https://www.fda.gov/media/136740/download. Accessed 04/13/2020, 2020.

70. InBios. Smart Detect(tm) SARS-CoV-2 rRT-PCR Kit. 2020; https://www.fda.gov/media/136786/download. Accessed 04/13/2020, 2020.

71. Becton_Dickinson_and_Company. BD SARS-CoV-2 Reagents for BD MAX(tm) System. 2020; https://www.fda.gov/media/136816/download. Accessed 04/13/2020, 2020.

72. Stanford_Health_Care_Clinical_Virology_Laboratory. ACCELERATED EMERGENCY USE AUTHORIZATION (EUA) SUMMARY SARS-CoV2 RT-PCR Assay. 2020; https://www.fda.gov/media/136818/download. Accessed 04/13/2020, 2020.

73. Diacarta. QuantiVirus™ SARS-CoV-2 Test Kit. 2020; https://www.fda.gov/media/136809/download. Accessed 04/13/2020, 2020.

74. SDI. ACCELERATED EMERGENCY USE AUTHORIZATION (EUA) SUMMARY The SDI SARS-CoV-2 Assay. 2020; https://www.fda.gov/media/136877/download. Accessed 04/13/2020, 2020.

75. Rutgers_Clinical_Genomics_Laboratory. ACCELERATED EMERGENCY USE AUTHORIZATION (EUA) SUMMARY SARS-CoV-2 ASSAY (Rutgers Clinical Genomics Laboratory). 2020; https://www.fda.gov/media/136875/download. Accessed 04/13/2020, 2020.

76. Orig3n_Inc. ACCELERATED EMERGENCY USE AUTHORIZATION (EUA) SUMMARY ORIG3N 2019 NOVEL CORONAVIRUS (COVID-19) Test 2020; https://www.fda.gov/media/136873/download. Accessed 04/13/2020, 2020.

77. UNC. ACCELERATED EMERGENCY USE AUTHORIZATION (EUA) SUMMARY UNC Health SARS-CoV- 2 real-time RTPCR test (University of North Carolina Medical Center). 2020; https://www.fda.gov/media/136880/download. Accessed 04/13/2020, 2020.

78. Baptist_Hospital_Pathology_Laboratory_Medicine. ACCELERATED EMERGENCY USE AUTHORIZATION (EUA) SUMMARY COVID-19 RT-PCR Test (Baptist Health Care System). 2020; https://www.fda.gov/media/136944/download. Accessed 04/15/2020, 2020.

79. Integrity_Laboratories. ACCELERATED EMERGENCY USE AUTHORIZATION (EUA) SUMMARY SARS- CoV-2 RT-PCR Assay (Integrity Laboratories). 2020; https://www.fda.gov/media/136942/download. Accessed 04/15/2020, 2020.

80. Ortho-Clinical_Diagnostics. VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total 619 9922 Reagent Pack Instructions for Use. 2020; https://www.fda.gov/media/136967/download. Accessed 04/16/2020, 2020.

81. ChemBio_Diagnostic_Systems. DPP® COVID-19 IgM/IgG System. 2020; https://www.fda.gov/media/136963/download. Accessed 04/16/2020, 2020.

82. Boston_Childrens_Hospital. ACCELERATED EMERGENCY USE AUTHORIZATION (EUA) SUMMARY CHILDRENS-ALTONA-SARS-COV-2 ASSAY (BOSTON CHILDREN’S HOSPITAL) 2020; https://www.fda.gov/media/136971/download. Accessed 04/16/2020, 2020.

83. Maccura. SARS-CoV-2 Fluorescent PCR Kit 2020; https://www.fda.gov/media/137026/download. Accessed 04/16/2020, 2020.

84. Mount_Sinai_Laboratory. ACCELERATED EMERGENCY USE AUTHORIZATION (EUA) SUMMARY COVID-19 ELISA IGG ANTIBODY TEST (MOUNT SINAI LABORATORY) 2020; https://www.fda.gov/media/137029/download. Accessed 04/16/2020, 2020.

85. CirrusDx. ACCELERATED EMERGENCY USE AUTHORIZATION (EUA) SUMMARY CIRRUSDX SARS- COV-2 (CIRRUSDX LABORATORY) 2020; https://www.fda.gov/media/137034/download. Accessed 04/16/2020, 2020.

86. HUMC. ACCELERATED EMERGENCY USE AUTHORIZATION (EUA) SUMMARY CDI ENHANCED COVID-19 TEST (HACKENSACK UNIVERSITY MEDICAL CENTER, MOLECULAR PATHOLOGY LABORATORY) 2020; https://www.fda.gov/media/137036/download. Accessed 04/16/2020, 2020.

87. GenoSensor. GSTM COVID-19 Real-Time PCR Kit. 2020; https://www.fda.gov/media/137093/download. Accessed 04/17/2020, 2020.

88. Curative-Korva. ACCELERATED EMERGENCY USE AUTHORIZATION (EUA) SUMMARY CURATIVE- KORVA SARS-COV-2 ASSAY (Curative-Korva, KorvaLabs Inc Clinical Laboratory). 2020; https://www.fda.gov/media/137089/download. Accessed 04/17/2020, 2020.

89. Fosun. Fosun COVID-19 RT-PCR Detection Kit. 2020; https://www.fda.gov/media/137120/download. Accessed 04/22/2020, 2020.

90. OSANG. GeneFinder™ COVID-19 Plus RealAmp Kit. 2020; https://www.fda.gov/media/137116/download. Accessed 04/22/2020, 2020.

91. Procomcure_Biotech_GmbH. PhoenixDx® 2019-nCoV. 2020; https://www.fda.gov/media/137153/download. Accessed 04/22/2020, 2020.

92. Mayo_Clinic. ACCELERATED EMERGENCY USE AUTHORIZATION (EUA) SUMMARY SARS-CoV-2 MOLECULAR DETCTION ASSAY (MAYO CLINIC) 2020; https://www.fda.gov/media/137163/download. Accessed 04/22/2020, 2020.

93. Seegene. AllplexTM 2019-nCoV Assay 2020; https://www.fda.gov/media/137178/download. Accessed 04/22/2020, 2020.

94. Diatherix_Eurofins. ACCELERATED EMERGENCY USE AUTHORIZATION (EUA) SUMMARY SARS- CoV2 RT-PCR Assay (Diatherix Eurofins Laboratory). 2020; https://www.fda.gov/media/137255/download. Accessed 04/24/2020, 2020.

95. Altona_Diagnostics. RealStar® SARS-CoV-2 RT-PCR Kit U.S. Instructions for Use. 2020; https://www.fda.gov/media/137252/download. Accessed 04/24/2020, 2020.

96. SD_Biosensor. STANDARD M nCoV Real-Time Detection kit. 2020; https://www.fda.gov/media/137302/download. Accessed 04/24/2020, 2020.

97. Microgen_DX. ACCELERATED EMERGENCY USE AUTHORIZATION (EUA) SUMMARY COVID-19 KEY ASSAY (MICROGEN DX, SOUTHWEST REGIONAL PCR LABORATORY LLC.). 2020; https://www.fda.gov/media/137370/download. Accessed 04/27/2020, 2020.

98. UDX. ACCELERATED EMERGENCY USE AUTHORIZATION (EUA) SUMMARY UDX SARS-COV-2 MOLECULAR ASSAY ULTIMATE DX CORP (UDX LABORATORIES. 2020; https://www.fda.gov/media/137372/download. Accessed 04/27/2020, 2020.

99. AIT_Laboratories. ACCELERATED EMERGENCY USE AUTHORIZATION (EUA) SUMMARY SARS-CoV- 2 (E, N and RdRP gene detection) Test (AIT Laboratories). 2020; https://www.fda.gov/media/137374/download. Accessed 04/27/2020, 2020.

100. Autobio. Anti-SARS-CoV-2 Rapid Test Instructions for Use. 2020; https://www.fda.gov/media/137367/download. Accessed 04/27/2020, 2020.

101. Ortho-Clinical_Diagnostics. VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack (version 2.0). 2020; https://www.fda.gov/media/137363/download. Accessed 04/27/2020, 2020.

102. DiaSorin. LIAISON® SARS-CoV-2 S1/S2 IgG ([REF] 311460). 2020; https://www.fda.gov/media/137359/download. Accessed 04/27/2020, 2020.

103. Abbott_Laboratories. SARS-CoV-2 IgG. 2020; https://www.fda.gov/media/137383/download. Accessed 04/30/2020, 2020.

104. Seasun_Biomaterials. U-TOP™ COVID-19 Detection Kit. 2020; https://www.fda.gov/media/137425/download. Accessed 04/30/2020, 2020.

105. Nationwide_Childrens_Hospital. ACCELERATED EMERGENCY USE AUTHORIZATION (EUA) SUMMARY SARS-CoV-2 ASSAY (NATIONWIDE CHILDREN’S HOSPITAL). 2020; https://www.fda.gov/media/137423/download. Accessed 04/30/2020, 2020.

106. Biocerna. ACCELERATED EMERGENCY USE AUTHORIZATION (EUA) SUMMARY Modified Thermo Fisher TaqPath COVID-19 SARS-CoV-2 Test (ORF1ab, N, and S gene detection) (Biocerna). 2020; https://www.fda.gov/media/137450/download. Accessed 05/04/2020, 2020.

107. Bio-Rad. Platelia SARS-CoV-2 Total Ab. 2020; https://www.fda.gov/media/137493/download. Accessed 05/04/2020, 2020.

108. Rheonix_Inc. Rheonix COVID-19™ MDx Assay. 2020; https://www.fda.gov/media/137489/download. Accessed 05/04/2020, 2020.

109. LabGenomics. Instructions for LabGun™ COVID-19 RT-PCR Kit. 2020; https://www.fda.gov/media/137483/download. Accessed 05/04/2020, 2020.

110. Altru_Diagnostics_Inc. ACCELERATED EMERGENCY USE AUTHORIZATION (EUA) SUMMARY Thermo Fisher TaqMan 2019-nCoV Assay Kit v1 (singleplex). 2020; https://www.fda.gov/media/137546/download. Accessed 05/04/2020, 2020.

111. NYSDOH. ACCELERATED EMERGENCY USE AUTHORIZATION (EUA) SUMMARY NEW YORK SARS- COV MICROSPHERE IMMUNOASSAY FOR ANTIBODY DETECTION (WADSWORTH CENTER AT THE NEW YORK STATE DEPARTMENT OF HEALTH). 2020; https://www.fda.gov/media/137541/download. Accessed 05/04/2020, 2020.

112. BioFire_Diagnostics_LLC. BioFire® Respiratory Panel 2.1 (RP2.1). 2020; https://www.fda.gov/media/137583/download. Accessed 05/04/2020, 2020.

113. Bio-Rad. Bio-Rad SARS-CoV-2 ddPCR Test. 2020; https://www.fda.gov/media/137579/download. Accessed 05/04/2020, 2020.

114. Roche_Diagnostics. Elecsys Anti-SARS-CoV-2. 2020; https://www.fda.gov/media/137605/download. Accessed 05/04/2020, 2020.

115. Euroimmun_US. Anti-SARS-CoV-2 ELISA (IgG) Instruction for use. 2020; https://www.fda.gov/media/137609/download. Accessed 05/04/2020, 2020.



FDA-APPROVED TESTS WITH EUA STATUS

The information in this table is based on the FDA Emergency Use Authorization website as of 05/04/2020.

TEST

COMPANY

DATE OF APPROVAL

AUTHORIZED SETTING
(H, M, W)ⱡ

NOTE(S) 

CDC 2019-Novel Coronavirus (2019-nCoV) Real- Time RT-PCR Diagnostic Panel

Centers for Disease Control and Prevention (CDC)

02/04/20

(Reissued 03/15/20)

H

Real-time RT-PCR12

New York SARS- CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel

Wadsworth Center, NYSDOH

02/29/20

(Reissued) 03/10/20)

H

Real-time RT-PCR38

cobas SARS-CoV-2

Roche Molecular Systems, Inc. (RMS

3/12/20

H, M

Real-time RT-PCR39

TaqPath COVID-19 Combo Kit

Thermo Fisher Scientific, Inc.

03/13/20

H

Real-time RT-PCR40

Panther Fusion SARS-CoV-2 Assay

Hologic, Inc.

03/16/20

H

Real-time RT-PCR41

COVID-19 RT-PCR Test

Laboratory Corporation of America

03/16/20

(Reissued 04/20/20)

H

Real-time RT-PCR14

Lyra SARS-CoV-2 Assay

Quidel Corp.

03/17/20

H

Real-time RT-PCR42

Quest SARS-CoV-2 rRT-PCR

Quest Diagnostics Infectious Disease, Inc.

03/17/20

H

Real-time RT-PCR43

Abbott RealTime SARS-CoV-2 assay

Abbott Molecular

03/18/20

H

Real-time RT-PCR44

Simplexa COVID- 19 Direct

DiaSorin Molecular LLC

03/19/20

H, M

Real-time RT-PCR45

ePlex SARS-CoV-2 Test

GenMark Diagnostics, Inc.

03/19/20

H, M

Real-time RT-PCR46

Primerdesign Ltd COVID-19 genesig Real-Time PCR assay

Primerdesign Ltd

03/20/20

H

Real-time RT-PCR47

Xpert Xpress SARS-CoV-2 test

Cepheid

03/20/20

H, M, W

Real-time RT-PCR approved for EUA status for either laboratory or POC27,48

BioFire COVID-19 Test

BioFire Defense, LLC

3/23/20

H, M

Real-time RT-PCR49

Accula SARS-Cov-2 Test

Mesa Biotech Inc.

3/23/20

H, M, W

Real-time RT-PCR50

PerkinElmer New Coronavirus Nucleic Acid Detection Kit

PerkinElmer, Inc.

03/24/20

H

Real-time RT-PCR51

AvellinoCoV2 test

Avellino Lab USA, Inc.

03/25/20

H

Real-time RT-PCR52

Real-Time Fluorescent RT- PCR Kit for Detecting SARS- CoV-2

BGI Genomics Co. Ltd

03/26/20

H

Real-time RT-PCR kit using fluorescence53

ID NOW COVID-19

Abbott Diagnostics Scarborough, Inc.

03/27/20

H, M, W

Isothermal nucleic acid amplification54

NxTAG CoV Extended Panel Assay

Luminex Molecular Diagnostics, Inc.

03/27/20

H

Real-time RT-PCR55

NeuMoDx SARS- CoV-2 Assay

NeuMoDx Molecular, Inc.

03/30/20

H, M

Real-time RT-PCR56

QIAstat-Dx Respiratory SARS- CoV-2 Panel

QIAGEN GmbH

03/30/20

H, M

Real-time RT-PCR57

SARS-CoV-2 PCR test

Yale New Haven Hospital, Clinical Virology Laboratory

03/31/20

H

Real-time RT-PCR58

qSARS-CoV-2 IgG/IgM Rapid Test

Cellex Inc.

04/01/20

H, M

Qualitative detection & differentiation of IgM and IgG antibodies59

COV-19 IDx assay

Ipsum Diagnostics, LLC

04/01/20

H

Real-time RT-PCR60

BioGX SARS-CoV-2 Reagents for BD MAX System

Becton, Dickinson & Company (BD)

04/01/20

H, M

Real-time RT-PCR61

SARS-CoV-2 RT-PCR test

Infectious Disease Diagnostics Laboratory - Children's Hospital of Philadelphia

04/02/20

H

Real-time RT-PCR62

SARS-Cov-2 Assay

Diagnostic Molecular Laboratory - Northwestern Medicine

04/02/20

H

Real-time RT-PCR63

MGH COVID-19 qPCR assay

Massachusetts General Hospital

04/03/20

H

Real-time RT-PCR64

ARIES SARS-CoV-2 Assay

Luminex Corporation

04/03/20

H, M

Real-time RT-PCR65

ScienCell SARS- CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit

ScienCell Research Laboratories

04/03/20

H

Real-time RT-PCR66

Logix Smart Coronavirus Disease 2019 (COVID-19) Kit

Co-Diagnostics, Inc.

04/03/20

H

Real-time RT-PCR67

Gnomegen COVID-19 RT-Digital PCR Detection Kit

Gnomegen LLC

04/06/20

H

RT-digital PCR assay for use with the QuantStudio™ 3D Digital PCR system68.

Viracor SARS-CoV- 2 assay

Viracor Eurofins Clinical Diagnostics

04/06/20

H

Real-time RT-PCR test69

Smart Detect SARS-CoV-2 rRT-PCR Kit

InBios International, Inc.

04/06/20

H

Real-time RT-PCR kit using fluorescence70

BD SARS-CoV-2Reagents for BD MAX System

Becton, Dickinson & Company

04/08/20

H, M

Real-time RT-PCR kit for BD-MAX™ System71

Stanford SARS- CoV-2 assay

Stanford Health Care Clinical Virology Laboratory

04/08/20

H

Real-time RT-PCR test72

QuantiVirus SARS- CoV-2 Test kit

DiaCarta, Inc.

04/08/20

H

Real-time RT-PCR kit73

iAMP COVID-19 Detection Kit

Atila BioSystems, Inc.

04/10/20

H

Real-time fluorescent reverse transcription isothermal assay

SDI SARS-CoV-2 Assay

Specialty Diagnostic (SDI) Laboratories

04/10/20

H

Real-time RT-PCR kit74

ThermoFisher - Applied Biosystems TaqPath COVID-19 Combo Kit

Rutgers Clinical Genomics Laboratory-Rutgers University

04/10/20

H

Real-time RT-PCR kit75

Orig3n 2019 Novel Coronavirus (COVID-19) Test

Orig3n, Inc.

04/10/20

H

Real-time RT-PCR test76

UNC Health SARS- CoV-2 real-time RT-PCR test

University of North Carolina Medical Center

04/10/20

H

Real-time RT-PCR test77

COVID-19 RT-PCR Test

Pathology/Laboratory Medicine Lab of Baptist Hospital Miami

04/13/20

H

Real-time RT-PCR test78

SARS-CoV-2 Assay

Integrity Laboratories

04/13/20

H

Real-time RT-PCR test79

VITROS Immunodiagnostic Products Anti- SARS-CoV-2 Total Reagent Pack

Ortho Clinical Diagnostics, Inc.

04/14/20

H, M

Reagents used with VITROS
Immunodiagnostic Products Anti-SARS- CoV-2 Total Calibrator (qualitative total antibody testing, serum)80

DPP COVID-19 IgM/IgG System

Chembio Diagnostic System, Inc.

04/14/20

H, M

Detection and differentiation of IgM and IgG antibodies in serum, plasma, venous whole blood, or fingerstick81

Childrens-Altona- SARS-CoV-2 Assay

Infectious Diseases Diagnostics Laboratory (IDDL), Boston Children’s Hospital

04/14/20

H

Real-time RT-PCR82

SARS-CoV-2 Fluorescent PCR Kit

Maccura Biotechnology (USA) LLC

04/15/20

H

Real-time RT-PCR83

COVID-19 ELISA IgG Antibody Test

Mount Sinai Laboratory

04/15/20

H

ELISA IgG-only antibody test (antibody formation 10-14 post-infection typically)84

CirrusDx SARS- CoV-2 Assay

CirrusDx Laboratories

04/15/20

H

Real-time RT-PCR85

CDI Enhanced COVID-19 Test

Hackensack University Medical Center (HUMC) Molecular Pathology Laboratory

04/15/20

H

Real-time RT-PCR86

GS™ COVID-19 RT- PCR KIT

GenoSensor, LLC

04/16/20

H

Real-time RT-PCR kit87

Curative-Korva SARS-Cov-2 Assay

KorvaLabs Inc.

04/16/20

H

Real-time RT-PCR kit88

Fosun COVID-19 RT-PCR Detection Kit

Fosun Pharma USA Inc.

04/17/20

H

Real-time RT-PCR kit89

GeneFinder COVID-19 Plus RealAmp Kit

OSANG Healthcare

04/18/20

H

Real-time RT-PCR kit90

PhoenixDx 2019- CoV

Trax Management Services Inc.

04/20/20

H

Real-time RT-PCR91

SARS-CoV-2 Molecular Detection Assay

Mayo Clinic Laboratories

04/20/20

H

Real-time RT-PCR92

Allplex 2019-nCoV Assay

Seegene, Inc.

04/21/20

H

Real-time RT-PCR93

SARS-CoV-2 PCR Test

Diatherix Eurofins Laboratory

04/22/20

H

Real-time RT-PCR94

RealStar SARS- CoV02 RT-PCR Kits U.S.

Altona Diagnostics GmbH

04/22/20

H

Real-time RT-PCR95

STANDARD M nCoV Real-Time Detection Kit

SD Biosensor, Inc.

04/23/20

H

Real-time RT-PCR96

COVID-19 Key

Southwest Regional PCR Laboratory LLC. dba MicroGen DX

04/23/20

H

Real-time RT-PCR97

UDX SARS-CoV-2 Molecular Assay

Ultimate Dx Laboratory

04/24/20

H

Real-time RT-PCR98

SARS-CoV-2 Assay

AIT Laboratories

04/24/20

H

Real-time RT-PCR99

Anti-SARS-CoV-2 Rapid Test

Autobio Diagnostics Co. Ltd.

04/24/20

H, M

Qualitative detection of IgM and IgG antibodies100

VITROS
Immunodiagnostic Products Anti- SARS-CoV-2 IgG Reagent Pack

Ortho-Clinical Diagnostics, Inc.

04/24/20

H, M

Chemiluminescent immunoassay for qualitative detection of IgG antibodies101

LIAISON SARS- CoV-2 S1/S2 IgG

DiaSorin Inc.

04/24/20

H, M

Chemiluminescent immunoassay for qualitative detection of IgG antibodies102

SARS-CoV-2 IgG assay

Abbott Laboratories Inc.

04/26/20

H, M

Chemiluminescent immunoassay for qualitative detection of IgG antibodies103

U-TOP COVID-19 Detection Kit

SEASUN BIOMATERIALS

04/27/20

H

Real-time RT-PCR104

SARS-CoV-2 Assay

Nationwide Children’s Hospital

04/27/20

H

Real-time RT-PCR105

SARS-CoV-2 Test

Biocerna

04/28/20

H

Real-time RT-PCR106

Platelia SARS-CoV- 2 Total Ab assay

Bio-Rad

04/29/20

H

Qualitative total antibody testing (including IgM, IgA, and IgG) using ELISA107

Rheonix COVID-19 MDx Assay

Rheonix, Inc.

04/29/20

H

Real-time RT-PCR108

LabGun COVID-19 RT-PCR Kit

LabGenomics Co., Ltd.

04/29/20

H

Real-time RT-PCR109

Altru Dx SARS- CoV-2 RT-PCR assay

Altru Diagnostics, Inc.

04/30/20

H

Real-time RT-PCR110

New York SARS- CoV Microsphere Immunoassay for Antibody Detection

NY State Department of Health

04/30/20

H

Qualitative total antibody testing (including IgM, IgA, and IgG) using Microsphere Immunoassay (MIA)111

BioFire Respiratory Panel 2.1

BioFire Diagnostics, LLC

05/01/20

H, M

Real-time RT-PCR panel test of 15 different viruses and four different bacteria112

Bio-Rad SARS- CoV-2 ddPCR Test

Bio-Rad Laboratories, Inc.

05/01/20

H

Real-time RT-PCR113

Elecsys Anti-SARS- CoV-2

Roche Diagnostics

05/02/20

H, M

Qualitative total antibody testing114

Anti-SARS-CoV-2 ELISA (IgG)

EUROIMMUN US Inc.

05/04/20

H

Qualitative IgG antibody testing (ELISA)115