INFORMATION FOR MEDICAL PROVIDERS

4 independent studies.
1,794 participants.
Real-world sensitivity and specificity.

Covid-Rapid is one of the few tests on the market backed by independent studies in four different countries with over 1,794 study subjects. As an immunity test, the performance from these real-world trials is unparalleled.

As a serology test, Covid-Rapid screens for antibodies which form several days after infection of COVID-19. Though no test is perfect, ours can detect immunity with a very low rate of false positives: Covid-Rapid has demonstrated 95% accuracy in identifying infected patients after Day 12.

When validated against PCR samples in four separate trials in China, Belgium, Switzerland, and at UC San Francisco and Harvard, our test showed exceptional specificity and very low cross reactivity, meaning low false negatives and virtually zero false positives. Our test performed at or above other forms of rapid testing. Cross reactivity with other coronaviruses is very low, and the almost complete lack of false positive results means that people who test positive can be confident that they have developed antibodies, and thus are likely immune. To our knowledge, few other COVID-19 serology tests have received “in vivo” results in multiple places.

PERCENTAGE OF PEOPLE TESTING POSITIVE WITH COVID-RAPID TEST

Days Symptomatic Aggregate China Belgium1 Switzerland2 Harvard/UCSF3
Covid-19 Day 0 – 6 28% 20%
Covid-19 Day 7 – 11 62% 60%
Covid-19 Day 12+ 100% 95%
Sensitivity (Days 0-21) 88.4% 93% 60% 90% 90.91%
Specificity 98.04% 97.5% 100% 100% 100%
Sample Size (n=) 1,794 1300 156 100 238

1 Dr. Pieter Vermeersch, PhD. Laboratory of Clinical Bacteriology and Mycology, University of Leuven, National Reference Center for Respiratory Pathogens.

2 Patrice Nordmann, MD PhD. Professor and Chair of Microbiology, Head Emerging Antibiotic Resistance Unit, Medical and Molecular Microbiology Department of Medicine, Faculty of Science and Medicine; Director INSERM European Laboratory (French National Institute for Health and Medical Research), Director National Reference Center for Emerging Antibiotic Resistance (Switzerland), University of Fribourg, Fribourg and Institute for Microbiology, University of Lausanne, University hospital Center, Lausanne, Switzerland

3 Test performance evaluation of SARS-CoV-2 serological assays by Harvard MGH, UCSF, UC-Berkeley. Jeffrey D. Whitman, M.D., M.S.1*, Joseph Hiatt, B.A.2,3,4,5,6,7*, Cody T. Mowery, B.S.2,3,5,6,7*, Brian R. Shy, M.D., Ph.D.1*, Ruby Yu, Ph.D.5,7*, Tori N. Yamamoto, Ph.D.5,6,7, Ujjwal Rathore, Ph.D.4,5,6,7, Gregory M. Goldgof, M.D., Ph.D.1, Caroline Whitty, B.S.1,5,7, Jonathan M. Woo, B.S.5,6,7, Antonia E. Gallman, B.S.2,5,8, Tyler E. Miller, M.D., Ph.D.36 , Andrew G. Levine, M.D., Ph.D.1, David N. Nguyen, M.D., Ph.D.5,6,9, Sagar P. Bapat, M.D., Ph.D.1,5,7, Joanna Balcerek, M.D., Ph.D.1, Sophia A. Bylsma, B.S.20, Ana M. Lyons, B.S.21, Stacy Li, B.S.21, Allison Wai-yi Wong, Ph.D.2, Eva Mae Gillis-Buck, M.Phil.10, Zachary B. Steinhart, Ph.D.5,7, Youjin Lee, Ph.D.5, Ryan Apathy, B.S.5,6,7, Mitchell J. Lipke, B.S.5,7, Jennifer Anne Smith, Ph.D.7,11, Tina Zheng, B.S.2,3,12,13, Ian C. Boothby, B.A.2,14, Erin Isaza, B.S.2,15, Jackie Chan, B.S.5, Dante D. Acenas II, B.A.5, Jinwoo Lee, Ph.D.2,16, Trisha A. Macrae, Ph.D.2,16, Than S. Kyaw, B.S.2,5, David Wu, B.S.2,3, Dianna L. Ng, M.D.13,17, Wei Gu, M.D., Ph.D.1, Vanessa A. York, B.S.18, Haig Alexander Eskandarian, Ph.D.18, Perri C. Callaway, B.A.18,19, Lakshmi Warrier, B.S.18, Mary E. Moreno, B.S.18, Justine Levan, Ph.D.18, Leonel Torres, B.S.18, Lila A. Farrington, Ph.D.18, Rita Loudermilk, B.S.22, Kanishka Koshal, M.P.H.22, Kelsey C. Zorn, M.H.S.23, Wilfredo F. Garcia-Beltran, M.D., Ph.D.36, Diane Yang, Ph.D.36, Michael G. Astudillo, M.D.36, Bradley E. Bernstein, M.D., Ph.D.36, Jeffrey A. Gelfand, M.D.37, Edward T. Ryan, M.D.37, Richelle C. Charles, M.D.37, A. John Iafrate, M.D., Ph.D.36, Jochen K. Lennerz, M.D., Ph.D.36, Steve Miller, M.D., Ph.D.1, Charles Y. Chiu, M.D., Ph.D. 1,9,24, Susan L. Stramer, Ph.D.25, Michael R. Wilson, M.D. 3,22, Aashish Manglik, M.D., Ph.D.27, Chun Jimmie Ye, Ph.D.28,29,30,31,32,33, Nevan J. Krogan, Ph.D.4,34,35, Mark S. Anderson, M.D., Ph.D.7, Jason G. Cyster, Ph.D.5,8, Joel D. Ernst, M.D.18, Alan H. B. Wu, Ph.D.1, Kara L. Lynch, Ph.D.1, Caryn Bern, M.D., M.P.H.33**, Patrick D. Hsu, Ph.D.6,20**, Alexander Marson, M.D., Ph.D.4,5,6,7,11,13,28,29,30**

COMPARISONS

When making a decision about Covid-Rapid, compare these results to conventional rapid tests that have been in frequent use by clinicians for years. For reference, see the following articles on rapid flu and strep tests. Both tests are widely used by clinicians as an affordable way to screen populations.

RAPID FLU TESTS
Source: EP Monthly

“The CDC notes that rapid influenza testing has a sensitivity ranging from approximately 50% to 70% — meaning that in up to half of influenza cases, the flu swab results will still be negative. Another study in Turkey showed that the sensitivity of rapid influenza testing for H1N1 ranged from 31.7% to 50%, again depending on the brand of test. A 2012 meta-analysis of the accuracy of rapid influenza testing showed an average sensitivity for detecting influenza in adults of only 54%. Sensitivity in children is somewhat higher since they tend to shed more virus. In most studies, the specificity of influenza testing is 90-95%, meaning that there is a much lower incidence of false positive results.”

RAPID STREP TESTS
Source: Medscape

“Numerous studies have demonstrated that the currently available rapid streptococcal tests have a sensitivity of 70-90% compared with standard throat cultures. In contrast to their relatively low sensitivity, the specificity of these rapid tests has consistently been 90-100%. Therefore, if a rapid streptococcal test result is positive, a culture is not necessary, and appropriate antibiotic therapy can be immediately initiated. However, when a negative rapid test result is encountered, a standard throat culture should always be obtained.”

OTHER COVID-19 TESTS
Study Conducted In: Specificity Sensitivity # of Study Subjects
China 97.5% 93% 1,300
Belgium 100% 60% * 156
API Covid-Rapid Switzerland 100% 90% * 100
Harvard 100% 90.91% 238
Total 98.04% 88.4% 1,794
Chembio China 97.6% 87% 83
Mount Sinai Laboratory No Public Information 100% 92% 83
Cellex

No Public Information

96% 93.8% 378
Ortho Clinical Diagnostics No Public Information 100% 83.3% 436
Stanford Health Care No Public Information No Public Information No Public Information No Public Information
Aytu Bioscience No Public Information 100% 91.9% 126
Safecare Biotech No Public Information No Public Information No Public Information No Public Information
Biomedomics No Public Information 90.6% 88.7% 525
PCR Antigen Test 100% 50-70%
Abbott Rapid PCR No Public Information 100%  100%  60 

* Results vary based on number of days (0-21) post infection, ranging from 20% in very early infecton to 95% after day 12. See additional data above.

† Under real world conditions: https://www.cnbc.com/2020/02/26/confusion-breeds-distrust-china-keeps-changing-how-it-counts-coronavirus-cases.html

‡ Tested using “contrived samples,” not real nasal swabs from COVID patients.