Actim SARS-COV-2 Notice D'utilisation page 5

Principle of the test
Actim SARS-CoV-2
The test includes the extraction and detection of SARS-CoV-2 virus antigens.
The test is based on immunochromatography. It utilizes monoclonal antibodies
to SARS-CoV-2 virus antigens. Antibodies against SARS-CoV-2 virus antigens
are bound to blue latex particles (the detecting label). Antibodies against
SARS-CoV-2 virus antigens are immobilized on a carrier membrane to catch the
complex of antigen and latex-labeled antibody and indicate a positive result.
When the dip area of the dipstick is placed in an extracted sample, the dipstick
absorbs liquid, which starts to flow up the dipstick. If the sample contains
SARS-CoV-2 virus, the virus antigen binds to the antibodies labeled with latex
particles. The particles are carried by the liquid flow and, if SARS-CoV-2 virus
antigen is bound to them, they bind to the corresponding catching antibody on
the membrane.
A blue line (test line) will appear in the result area if the concentration of SARS-
CoV-2 virus in the sample exceeds the detection limit of the test.
Actim Influenza A&B
The test includes the extraction and detection of influenza type A and B virus
antigens. The test is based on immunochromatography. It utilizes monoclonal
antibodies to influenza type A and type B virus antigens. Antibodies against both
types are bound to blue latex particles (the detecting label). Antibodies against
both types are immobilized on a carrier membrane to catch the complex of
antigen and latex-labeled antibody and indicate a positive result.
When the dip area of the dipstick is placed in an extracted sample, the dipstick
absorbs liquid, which starts to flow up the dipstick. If the sample contains
influenza type A or B, the virus antigen binds to either of the antibodies labeled
with latex particles. The particles are carried by the liquid flow and, if influenza
virus antigen is bound to them, they bind to the corresponding catching antibody
on the membrane. A blue line (test line) will appear in the lower part of the result
area if the concentration of influenza type A in the sample exceeds the detection
limit of the test. A blue line (test line) will appear in the middle of the result area
if the concentration of influenza type B in the sample exceeds the detection limit
of the test. Appearance of the black control line confirms correct performance
of the test.
Performance of the test
Actim SARS-CoV-2
Analytical Sensitivity
The analytical sensitivity of Actim SARS-CoV-2 test was assessed using
SARS-CoV-2 viral strain FIN-25. The detection limit of SARS-CoV-2 virus is
0.5 x 10 TCID /ml in extracted sample and the result remain positive at least to
2
50
2 x 10 TCID /ml.
5
50
Analytical Specificity
Actim SARS-CoV-2 was evaluated with the viruses listed below. A negative test
result was obtained with all viruses. Test results indicate that Actim SARS-
CoV-2 test is specific for COVID-19.
Viruses
Human coronavirus 229E
Human coronavirus OC43
Human coronavirus NL63
Influenza A virus
Influenza B virus
MERS
Enterovirus
Respiratory syncytial virus (A&B)
Respiratory syncytial virus
Repeatability and Reproducibility
A panel of samples containing SARS-CoV-2 antigen (low positive and high
positive) and a negative sample was evaluated for intra- (repeatability) and
inter- (reproducibility) assay precision. For repeatability the samples were
tested with 10 replicates during the same day using three lots of the Actim
SARS-CoV-2 test. For reproducibility, the samples were tested by three
operators on five days using three lots of the Actim SARS-CoV-2 test. Test shows
consistent performance within run, between runs, between operators, between
lots and between days. One hundred percent (100%) agreement with expected
test results was obtained.
Interfering substances
Different nasal sprays (5%), nasal corticosteroid (5%) and whole blood (5%) were
tested with Actim SARS-CoV-2 test. No interference of these substances or
whole blood was observed with the test performance.
Concentration tested
5x10 TCID /ml
6
50
1x10 TCID /ml
9
50
14.2 µg/ml
5x10 pfu/ml
6
2x10 pfu/ml
6
60 mg/l
1x10 pfu/ml
6
2x10 pfu/m
6
450 mg/l
EN
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