Product Manual

3 (6)
pipette provided with the test dispenses approximately 10 µl
in one drop even if more blood is aspirated in the pipette.
e. Add 2 drops of buffer (approximately 80μl) to the buffer well
(B) and start the timer. Wait for the colored line(s) to appear.
Read results at 10 minutes. Do not interpret results after
20 minutes.
INTERPRETATION OF RESULTS
POSITIVE
IgG and IgM POSITIVE: * Three
lines appear. If the C-line, M-line,
and G-line are all present, it means
that SARS-CoV-2 IgG and IgM
antibody are detected, and the result
is IgG and IgM antibody positive.
IgG POSITIVE: * Two lines appear.
If both the C-line and the G-line
appear, it means the IgG antibody
against SARS-CoV-2 is detected, and
the result is IgG antibody positive.
IgM POSITIVE: * Two lines appear.
If both the C-line and M-line appears,
it means that the IgM antibody
against SARS-CoV-2 is detected, and
the result is IgM antibody positive.
NEGATIVE
One colored line appears in the
control region (C). If only C-line
appears, indicating that SARS-CoV-2
antibody is not detected, and the
result is negative.
INVALID
Control line fails to appear.
If C-line is not observed, it is invalid
whether there is detection line or not,
and the detection should be carried
out again.
Insufficient specimen volume or
incorrect procedural techniques are
the most likely reasons for control line
failure. Review the procedure and
repeat the test with a new test. If the
problem persists, discontinue using
the test cassette immediately and
contact your distributor.
QUALITY CONTROL
A procedural control is included in the test. A colored line appearing in
the control line region (C) is considered an internal procedural control.
It confirms adequate membrane wicking.
Control standards are not supplied with this test cassette; however,
testing of positive and negative controls is required as a good
laboratory practice to confirm the test procedure and to verify proper
test performance.
Negative, and IgG/IgM Positive controls manufactured by Kenlor
Industries USA should be purchased from Clarity Diagnostics (Catalog
Number: CD-COV19-GMCTL). Users should refer to the instructions
for use for the external controls. External controls should be run like
human specimens using the instructions described herein. It is
recommended that positive and negative controls are tested each time
a new lot is used, when a new operator performs the test, or when the
test is run in a new room/laboratory, etc. as a good laboratory practice
to confirm the test procedure and to verify proper test performance.
LIMITATIONS
1. Not for use in at-home testing settings.
2. The test is limited to the qualitative detection of antibodies
specific for the SARS-CoV-2 virus. The intensity of the test line
does not necessarily correlate to SARS-CoV-2 antibody titer in
the specimen. This test cannot be used as a semi-quantitative or
quantitative test.
3. This test can only be used for the analysis of serum, plasma (K
2
EDTA, Na+ heparin, and Na+ citrate), venous whole blood (K
2
EDTA, Na+ heparin, and Na+ citrate), and fingerstick (capillary)
whole blood samples.
4. Plasma samples obtained from K
2
EDTA anticoagulant should
not be tested after one day of storage due to potential for false
positive results.
5. Negative results do not rule out SARS-CoV-2 infection
,
particularly in those who have been in contact with the virus.
Direct testing with a molecular diagnostic should be performed
to evaluate for acute infection in symptomatic individuals.
6. Negative results do not preclude SARS-CoV-2 infection and
should not be used as the sole basis for patient management
decisions. IgM antibodies may not be detected in the first few
days of infection; the sensitivity of the Clarity COVIBLOCK
TM
COVID-19 IgG/IgM Rapid Test Cassette early after infection is
unknown.
7. False positive results for IgM and IgG antibodies may occur due
to cross-reactivity from pre-existing antibodies or other possible
causes.
Positive results may be due to past or present infection
with non-SARS-CoV-2 coronavirus strains, such as coronavirus
HKU1, NL63, OC43, or 229E.
8. False positive results may occur in individuals with Rheumatoid
Factor (RF).
9. A negative result can occur if the quantity of antibodies for the
SARS-CoV-2 virus present in the specimen is below the
detection limit of the assay, or if the virus has undergone minor
amino acid mutation(s) in the epitope recognized by the
antibody used in the test.
10. The assay procedure and the interpretation of assay result must
be followed closely when testing for the presence of SARS-CoV-
2 virus specific antibodies in the serum, plasma, or whole blood
specimen from individual subjects. For optimal test performance,
proper sample collection is critical. Failure to follow the
procedure may give inaccurate results.
11. Reading test results earlier than 10 minutes after the addition of
buffer may yield erroneous results. Do not interpret the result
after 20 min.
12. Early after infection, anti-SARS-COV-2 IgM concentrations may
be below detectable levels.
13. The continued presence or absence of antibodies cannot be
used to determine the success or failure of therapy.
14. Results from immunosuppressed patients should be interpreted
with caution.
15. As with all diagnostic tests, all results must be interpreted
together with other clinical information available to the physician.
16. A positive result may not indicate previous SARS-CoV-2
infection. Consider other information, including clinical history
and local disease prevalence, in assessing the need for a
second but different serology test to confirm an adaptive immune
response.
17. Not for the screening of donated blood.
18. The sensitivity of the test is impacted after being opened for 1
hour- the intensity of the test line(s) will become weak. Testing
must be performed within 1 hour after opening the pouch.
CONDITIONS OF AUTHORIZATION FOR LABORATORY
The Clarity COVIBLOCK
TM
COVID-19 IgG/IgM Rapid Test Cassette
Letter of Authorization, along with the authorized Fact Sheet for
Healthcare Providers, the authorized Fact Sheet for Patients, and
authorized labeling are available on the FDA website:
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-
19-emergency-use-authorizations-medical-devices/vitro-diagnostics-
euas
Authorized laboratories using the Clarity COVIBLOCK
TM
COVID-19
IgG/IgM Rapid Test Cassette (“your product” in the conditions below),
must adhere to the Conditions of Authorization indicated in the Letter
of Authorization as listed below: