Antigen Test

1. China 

435 total nasal and nasopharyngeal swabs were used. All the specimens used in this evaluation were form The Red Flag Hospital of Mudanjiang at the Clinical Cooperation Unit of Norman, Hubei Hospital of Integrated Traditional Chinese and Western Medicine, and Wuhan Keyuan Hospital. For those 115 positive samples that PCR cycle time was known, 7 of the 8 false negatives were cycle time >36 and the last was cycle time 33-36. All positive patients were symptomatic at some point. 

API Covid-Rapid Antigen Test PCR Test Total
Positive Negative
Positive 181 2 183
Negative 14 238 252
Total 195 240 435

Analysis of coincidence rate of API Covid-Rapid Antigen Test and PCR Test in nasal and nasopharyngeal swab samples:

Positive coincidence rate (Sensitivity): 181/ (181+14) × 100% = 92.8%

Negative coincidence rate (Specificity): 238 / (2+238) × 100% = 99.16%

Data for 180 PCR positives with known PCR cycle times

API Covid-Rapid Antigen Test BGI PCR Test
Ct <36 Ct>=36
True Positives 107 0
False Negatives 1 7
Total 108 7

2. Poland 

Under the direction of Dr. Aleksandra Zimmer, Principal Investigator, we prospectively recruited 105 females from Wroclaw University Hospital, largely from the OB/GYN department. Patients performed their own nasal swab using the API Pharma Covid-Rapid Antigen test. They also performed all steps including adding reagent, adding to sample well, and interpreting results. They were asked their opinion of their results (pos, neg, invalid). A nurse monitored their progress to make sure they do it correctly and confirmed their results. The healthcare provider then performed nasopharyngeal swab for PCR comparator. Swab was placed in viral transport media and sent to the nearest lab for processing. There was 100% concordance between the patient interpreted and nurse interpreted results. The comparator PCR test was the VIASURE SARS-CoV-2 Real Time PCR Detection Kit with cycle time up to 38 cycles for positives. 

API Covid-Rapid Antigen Test PCR Test Total
Positive Negative
Positive 2 0 2
Negative 1 102 103
Total 3 102 105

Analysis of coincidence rate of API Antigen Test and PCR VIASURE in nasal swab samples:

Positive coincidence rate (Sensitivity): 2/ (2+1) × 100% = 66%

Negative coincidence rate (Specificity): 102 / (102+0) × 100% = 100%

Total coincidence rate (Accuracy): (2+102) / (2+1+102+0) × 100% = 99.0%

3. Dallas, Texas 

Using known positive clinical samples that had been frozen in viral transport media since procurement from August to October 2020, Kai Medical Labs in Dallas, Texas performed a validation on October 29-30, 2020 using antigen test lot number 20200918. We used 10 PCR confirmed positive and 10 PCR confirmed negative samples. All results demonstrate 100% sensitivity and specificity. 

API Covid-Rapid Antigen Test PCR Test Total
Positive Negative
Positive 10 0 10
Negative 0 10 10
Total 10 10 20

Analysis of coincidence rate of API Covid-Rapid Antigen Test and PCR Test in nasal swab samples:

Positive coincidence rate (Sensitivity): 10/ (10) × 100% = 100%

Negative coincidence rate (Specificity): 10 / (10) × 100% = 100%

 
Rapid Result Antigen
PCR Result (Cycle Threshold) Agreement
1 + 19.029 Yes
2 + 15.914
Yes
3 + 22.336 Yes
4 + 23.976 Yes
5 + 21.83 Yes
6 + 14.085 Yes
7 + 16.493 Yes
8 + 15.236 Yes
9 + 25.658 Yes
10 + 34.766 Yes

Point of care data:

Please see Poland Clinical Data results laid out above. The tests were performed by over a dozen nurses, seven doctors, and 100 individual patients. They were also interpreted by each of those individuals and all tests were interpreted twice—once by the patient and once by the provider. There was 100% concordance between providers and patients. The sensitivity of the test versus PCR comparator was 90% and 100% specificity. While this was done in a hospital setting, it was not in the laboratory and the provider and patient interpretations clearly demonstrate that the test can be performed and interpreted in a point of care, CLIA-waived setting with accuracy and replicability.