AS SENSITIVE AND SPECIFIC AS PCR NASAL SWABS, IN ONLY 15 MINUTES.

API Pharma’s next generation point of care antibody test is manufactured in the USA and the clinical studies were performed in the USA as well so you know the data can be trusted. From the first day of symptoms, or even for those without any symptoms, a few drops of blood yields accurate results.

The test has no cross-reactivity with other coronaviruses and the 100% specificity means that even where there is low prevalence, the positive and negative predictive values will be very high.

SARS-CoV-2 IgM/IgG Ab

Days from Symptom Onset To Blood Collection Number Of Samples 2019-nCoV RT PCR Result IgM (+) IgG (+) IgM (+) and/or IgG (+)
1-5 Days 14 Pos 14 14
6-10 Days 16 Pos 16 16
11-15 Days 0
16-20 Days 0
>20 Days 0
Asymptomatic 25 Pos 23 25 25

SARS-CoV-2 IgM Ab

SARS-CoV-2 IgM Ab

Rapid Test

PCR Test

Total

Positive

Negative

Positive

50

0

50

Negative

5

85

90

Total

55

85

140

Analysis of coincidence rate of SARS-CoV-2 IgM Ab rapid test and PCR Test in blood samples.

Positive Percent Agreement=50 / (50+5) × 100% = 90.7%

Negative Percent Agreement =85 / (85+0) × 100% = 100%

SARS-CoV-2 IgG Ab

SARS-CoV-2 IgG Ab

Rapid Test

PCR Test

Total

Positive

Negative

Positive

55

0

55

Negative

0

85

85

Total

55

85

140

Analysis of coincidence rate of SARS-CoV-2 IgG Ab rapid test and PCR Test in blood samples.

Positive Percent Agreement=50 / (55+0) × 100% = 100%

Negative Percent Agreement =85 / (85+0) × 100% = 100%

This validation study has been reviewed and the performance of the Sure Bio-tech, Ltd.  SARS-CoV-2 IgM/IgG Antibody Rapid Test method is considered acceptable for patient testing of SARS-CoV-2 IgG/IgM Antibody.

Coordinating  Testing:   Michael Haines

Date:   7.3.2020

Technical Supervisor:  Kathleen Braniff, MSA, MT(ASCP)

Date:   7.7.2020

Laboratory Director:

Date: