Artron Laboratories Inc. www.artronlab.

com
Tel: 604-415-9757
3938 North Fraser Way, Burnaby, BC
Canada V5J 5H6 Fax: 604-415-9795

Artron COVID-19 Antigen Test Kit

Principle of the assay

Artron COVID-19 Antigen test is an antigen-capture immunochromatographic assay,
detecting presence of SARS-COV-2 viral spike antigen in nasal swab, nasopharyngeal swab
or Bronchoalveolar Lavage samples. This assay utilizes the chemical extraction of viral
antigens followed by solid-phase immunoassay technology for the detection of extracted
antigen of SARS-COV-2. Monoclonal antibodies specifically against SARS-COV-2 antigen are
conjugated with colloidal gold and deposited on the conjugate pad and immobilized on the
Test Zone on the nitrocellulose membrane. When a sample is added, the gold-antibody
conjugate is rehydrated and the SARS-COV-2 antigen, if any in the sample, will interact
with the gold conjugated antibodies. The antigen-antibody-gold complex will migrate
towards the test window until the Test Zone where they will be captured by immobilized
antibodies, forming a visible pink line (Test band) indicative of positive results. If SARS-COV-
2 antigen are absent in the sample, no pink line will appear in the Test Zone (T).
To serve as an internal process control, a control line should always appear at Control Zone
(C) after the test is completed. Absence of a pink control line in the Control Zone is an
indication of an invalid result.

Results interpretation:

Negative:
A pink colored band appears only at the control region (C), indicating a negative result for
COVID-19 Infections.
 Artron Laboratories Inc. www.artronlab.com
Tel: 604-415-9757
3938 North Fraser Way, Burnaby, BC
Canada V5J 5H6 Fax: 604-415-9795

Positive:
A clear pink control band (C) and a detectable test band (T) appears, indicating a positive result
for COVID-19 infections.
Invalid:
No visible band appears at the control region. Repeat with a new test kit. If the test still fails,
please contact the distributor with the lot number.

Evaluation studies:
Internal evaluation on antigen test:
Internal evaluation conducted at the research division of Artron Laboratories showed that the
Artron COVID-19 Antigen test was able to detect as low as 1.25 ng/ml of the viral protein, making
it an extremely sensitive test.
Different strengths of the SARS-COV-2 protein ranging from 125µg/ml to 1.25ng/ml were used
to test the analytical sensitivity of the Artron COVID-19 Antigen test. Results revealed that the
test was able to detect viral protein from 125µg/ml to 1.25ng/ml concentration. At higher
concentrations, band at the control region was not visible as expected and indicated that the
binding of antibody to antigen in the sample is particularly strong.
 Artron Laboratories Inc. www.artronlab.com
Tel: 604-415-9757
3938 North Fraser Way, Burnaby, BC
Canada V5J 5H6 Fax: 604-415-9795

External evaluation on Artron COVID-19 antigen test:

Tested at- At Artron India office
Tested on – 16th July 2020 - 10th August 2020
36 patient samples out of which 18 confirmed SARS-COV-2 negative, 15 confirmed SARS-COV-2
positive by RT-PCR or SD antigen test and 3 samples not tested by any of RT-PCR or SD-Antigen
test, were tested on Artron SARS-COV-2 Antigen test (on two different lots which are Lot A =
200501 (Regular) and Lot B = 200715 (High sensitivity). Detail on the samples and the
confirmatory methods is provided in Table 1.

Table 1: Sample details

Negative for
Total number of Positive for SARS-COV-2 antigen SARS-COV-2
samples tested antigen
(36)
18 18

SD
RT-PCR+ SD RT-PCR+ SD
Initial RT-PCR Antigen Un-identified
Antigen Test Antigen
confirmation test
method Test
3 10 2 3

Confirmed on
Artron COVID- 3 10 2 3 18
19 Antigen Test
 Artron Laboratories Inc. www.artronlab.com
Tel: 604-415-9757
3938 North Fraser Way, Burnaby, BC
Canada V5J 5H6 Fax: 604-415-9795

Results: Test cassettes marked with “A” are from the lot no. 200501 and the ones marked with
“B” are from the lot no. 200715.

Group 1: RT-PCR/ SD Test Negative and tested negative on Artron COVID-19 Antigen Test
as well
 Artron Laboratories Inc. www.artronlab.com
Tel: 604-415-9757
3938 North Fraser Way, Burnaby, BC
Canada V5J 5H6 Fax: 604-415-9795

Group 2: RT-PCR positive and tested positive on Artron COVID-19 Antigen Test as well

Group 3: SD antigen test positive and tested positive on Artron COVID-19 Antigen Test
as well
 Artron Laboratories Inc. www.artronlab.com
Tel: 604-415-9757
3938 North Fraser Way, Burnaby, BC
Canada V5J 5H6 Fax: 604-415-9795

Group 4: RT-PCR and SD Antigen test positive and tested positive on Artron COVID-19 Antigen
Test

Group 5: Tested positive only on Artron COVID-19 Antigen Test and not tested using RT-
PCR/SD-Antigen test
 Artron Laboratories Inc. www.artronlab.com
Tel: 604-415-9757
3938 North Fraser Way, Burnaby, BC
Canada V5J 5H6 Fax: 604-415-9795

Comparison between SD antigen test and Artron COVID-19 Antigen Test

Artron COVID-19 Antigen Test was compared with SD Antigen Test and the band intensity was
stronger on Artron COVID-19 Antigen Test.

Sensitivity and specificity:

Although the number of samples tested using our product is low and we understand that it is not
sufficient to calculate the sensitivity and specificity of Artron COVID-19 Antigen Test, yet the
comparison carried out between RT-PCR/SD Antigen Test and Artron COVID-19 Antigen Test gave
a preliminary idea about the sensitivity and specificity of Artron COVID-19 Antigen Test. The data
showed that our product was able to pick up all the confirmed SARS-COV-2 antigen positive and
negative samples.