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Serology Shortlist for EUA SARS-COV-2 Testing

By end of June 2020, the list of methods for SARS-COV-2 testing (molecular, antigen, rapid, and serology), had exceeded 730.  Rather than ask laboratories to evaluate 730 possibilities, we've narrowed the candidates down to a short list.

Serology "Shortlist" for EUA SARS-COV-2 Testing

Updated June 30, 2020

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To date (June 30) only 23 antibody tests have have EUA status from FDA in the US.

[Please note: at this time, this shortlist is focused on the methods running on instruments, not rapid LFIAs or cassette style testing. That section will be forthcoming.]

Our COVID-19 special coverage:

 
There are hundreds of new methods on the market to test for virus, antigens, and antibodies. In the crisis mode of the COVID19 pandemic, the floodgates were opened. Anyone with a desire to sell a new method was allowed into the market. Now that the sprint has turned into a marathon, laboratories and regulators are starting to scrutinize methods more closely.

One of the easiest ways to winnow the field is to focus on which manufacturers have submitted and obtained an EUA (Emergency Use Authorization). 

Next, is to narrow that further by focusing on methods that have achieved the FDA goal of 90% sensitivity and 95% specificity.

To further flesh out the list, we've been scouring the pre-print services to locate relevant papers that document the real-world performance of these methods. As we know from all other areas of testing, the first set of data on performance, delivered by the manufacturer itself, can sometimes be overly optimistic. What looks great at launch may not be that good in the field. So we can supplement the data from the manufacturer with reality checks from the front lines of the pandemic fight.

There are further sources of data - for instance, the NHS in the UK has evaluations performed by Public Health England Porton Down (PHE Porton Down). The FDA is conducting independent evaluations of serology methods and is releasing those on the Open FDA website. It's also useful to know which methods have been approved in other countries than the US. France, the UK, Canada have publicly accessible lists of their approved methods.

We've noted the sensitivty and specificity of these tests for a specific window of infection, for patients who are >10 or >14 or >15 days from either positive PCR test or symptoms. Given the immunology response curves, it's fruitless to expect IgG or IgM to have a higher sensitivity in the immediate days after infection.  This points to the continuing need for PCR testing - in order to detect the active disease, you need the diagnostic test. Serology is for surveillance and history and possible, we hope, proof of immunity.

We have noted, where possible, the number of positive and negative samples used to determine sensitivity and specificity of the methods.  More is better.  To see a method where they tested thousands of patient samples to determine specificity is heartening. You can have more confidence in that method than one where they tests only 30, 40, 50 samples.

Also note that even if a method doesn't meet the FDA goals for performance, that doesn't automatically discount them for use in your laboratory - particularly if you can consider an orthogonal approach. If you can combine too less-than-perfect tests in confirmatory protocols, you can get a better combined result than either single test can provide. It may seem like too much effort or expense to run more than one test, but the FDA is strongly advising it. Given the mass scale of testing we will need to perform to truly fight the pandemic, additional testing to make sure our results are as accurate as possible is critical.

Our aim is that when we can combine all these evaluations, we may not see that there is one perfect method, but definitely some methods seem to be performing better than others. This may shorten your list of methods to consider when you choose a serology method.

The data is changing every day, expect that this short list will expand, contract, fluctuate, etc. Stay tuned.

Test Sensitivity PPA PPA n Specificity NPA NPA n PASS FDA 90-95? Source
Abbott Alinity I SARS-CoV-2 IgG 100 88/88 99.63 1066/1070 YES FDA/IFU
Abbott ARCHITECT  SARS-CoV-2 IgGAbbott 100 88/88 99.63 1066/1070 YES  FDA/IFU 
91.8 56/61 99.6 253/254 YES Pre-print, Mayo Clinic, MN
96.9   99.9 1012/1020 YES Pre-print, University of Washington, Idaho
93.8   99.4   YES Pre-print, University of Washington, St.Louis
93.9 77/82 100 757/757 YES PHE Porton Down evaluation
96.8 30/31 99 99/100 YES Pre-print, University of Kiel, Germany
85 17/20 100 100/100 NO pre-print, Ekelund et al, Växjö Central Hospital, Växjö, Sweden
Bio-Rad Platelia SARS-CoV-2 Total Ab 92.2 47/51 99.6 684/687 YES FDA/IFU
Beckman Coulter Access IgG 96.8 92/95 99.6 1395/1400 YES FDA/IFU
Diasorin Liaison SARS-CoV-2 S1/S2 IgG 97.6 40/41 99.3 1082/1090 YES FDA/IFU
94.4 17/18 96.9 68/69 YES pre-print, Erasmus MC, Rotterdam, Netherlands
91.3 116/127 97.0 1339/1380 YES pre-print, University of Pavia >5 days
90.3 28/31 96 96/100 YES Pre-print, University of Kiel, Germany
Euroimmun SARS-COV-2 ELISA IgG 90 27/30 100 80/80 YES FDA/IFU
Euroimmun SARS-COV-2 ELISA IgG 90 27/30 100 80/80 YES FDA study data
Euroimmun SARS-COV-2 ELISA IgA 90.5 38/42 88.4 76/86 n/a pre-print Univ. Chicago, >4 days PCR+
Euroimmun SARS-COV-2 ELISA IgG 100 42/42 97.7 84/86 YES pre-print Univ. Chicago, >4 days PCR+
Euroimmun SARS-COV-2 ELISA IgG 93.8 15/16 95.7 22/23 YES pre-print Institute for Medical Virology, Frankfurt, Germany
Euroimmun SARS-COV-2 ELISA IgA 86.7 13/15 80 16/20 n/a pre-print, Montellier University, France
Euroimmun SARS-COV-2 ELISA IgG 86.7 13/15 85 17/20 NO pre-print, Montellier University, France
Euroimmun SARS-COV-2 ELISA IgG 87.3 62/71 84.8 95/112 NO pre-print, hospitalized patients, University Geneva Hospitals, Switzerland, 11-20 days patients
Euroimmun SARS-COV-2 ELISA IgG 80.5 33/41 84.8 95/112 NO pre-print, outpatient  patients, University Geneva Hospitals, Switzerland 11-20 days patients
Euroimmun SARS-COV-2 ELISA IgG 96.15 25/26 99.38 160/161 YES pre-print, Erasmus MC, Rotterdam, Netherlands
Euroimmun SARS-COV-2 ELISA IgA 1 26/26 93.79 151/161 n/a pre-print, Erasmus MC, Rotterdam, Netherlands
Euroimmun SARS-COV-2 ELISA 100 61/61 98 249/253 YES Pre-print, Mayo Clinic, MN
Euroimmun SARS-COV-2 ELISA IgA 85.4   94.8   n/a Pre-print, University of Washington, St.Louis
Euroimmun SARS-COV-2 ELISA 87.1 27/31 97 97/100 NO Pre-print, University of Kiel, Germany
InBios SCoV-2 Detect IgG ELISA 95.45 21/22 98.95 94/95 YES FDA/IFU
Mount Sinai Hospital COVID-19 ELISA Ab 92.5 37/40 100 74/74 YES FDA/IFU
Ortho-Clinical VITROS Anti-SARS-CoV-2 IgG 90.0 36/40 100 407/407 YES FDA/IFU. Updated.
Ortho-Clinical VITROS Anti-SARS-CoV-2 IgG 100 61/61 99.6 253/254 YES Pre-print, Mayo Clinic, MN
Ortho-Clinical VITROS Anti-SARS-CoV-2 IgG 79.7 63/79 99.7 390/391 NO PHE Porton Down evaluation
Ortho-Clinical VITROS Anti-SARS-CoV-2 Total Reagent 100 49/49 100 400/400 YES FDA/IFU
Roche Elecsys Anti-SARS-CoV-2 100 29/29 99.8 5262/5272 YES FDA/IFU
87.7 64/73 100 387/387 NO PHE Porton Down evaluation
91.7 55/60 91.1 72/79 NO pre-print, Clinique St Luc Bouge, Belgium, Julien Favresse et al  >14 days
100 20/20 98 98/100 YES pre-print, Ekelund et al, Växjö Central Hospital, Växjö, Sweden
96.8 30/31 99 99/100 YES Pre-print, University of Kiel, Germany
99.5 184/185 99.8 10,432/10,453 YES Pre-print, Internal Roche Study, >14 days
97.1 68/70 100 714/714 YES Pre-print, Changi, Singapore, > 14 days
Siemens Atellica SARS-COV-2 IgG/IgM 100 42/42 99.8 1089/1091 YES FDA/IFU
89.4 76/85 100 499/499 NO PHE Porton Down Evaluation >14 days
Siemens ADVIA SARS-COV-2 IgG/IgM 100 47/47 99.8 1586/1589 YES FDA/IFU
Siemens Dimension Vista SARS-COV-2 Total Antibody 100 72/72 99.8 1526/1529 YES FDA/IFU >14 days PCR+
Siemens Dimension EXL SARS-COV-2 Total Antibody  100 72/72 99.87 1527/1529 YES FDA/IFU >14 days PCR+
Vibrant COVID-19 Ab IgG/IgM 98.11 52/53 98.6 494/501 YES FDA/IFU
Wadsworth New York SARS-CoV Microsphere IA 88 95/108 98.8 428/433 NO FDA/IFU
 

 

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