Product Manual

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• This test has been authorized only for detecting the presence of
IgM and IgG antibodies against SARS-CoV-2, not for any other
viruses or pathogens.
• Do not use after expiration date.
• Do not use if the pouch is torn or open.
• Do not eat, drink or smoke in the area where the specimens or kits
are handled.
• Handle all specimens as if they contain infectious agents. Observed
established precautions against microbiological hazards throughout
the procedure and follow the standard procedures for proper
disposal of specimens.
• Wear protective clothing such as laboratory coats, disposable
gloves and eye protection when specimens are assayed.
• The used tests, specimens and potentially contaminated material
should be discarded according to the local regulations.
• Once the cassette is removed from the pouch, Use the cassette as
soon as possible to avoid being humidified. The cassette is
sensitive to humidity as well as to heat.
• Use only the buffer solution provided with the kit.
• Do not use the cassette if the pouch is damaged or the seal is
broken.
• Avoid cross-contamination of samples by using a new pipette tip or
disposable plastic pipette.
TEST KIT COMPONENTS
SPECIMEN COLLECTION AND PREPARATION
• Use standard phlebotomy procedures to collect venipuncture
whole blood, serum, and plasma specimen.
• If specimens are to be shipped, they should be packed in
compliance with federal regulations for transportation of etiologic
agents.
SPECIMEN PRESERVATION
• Fingerstick whole blood specimens must be tested immediately
after collection.
• Serum and plasma specimens (Na+ Citrate, Na+ Heparin) that will
not be tested immediately can be kept at 2° – 8°C (36 – 46
o
F) for
up to 5 days.
• Plasma specimens (K
2
EDTA) that will not be tested immediately
can be kept at 2° – 8°C (36 – 46
o
F) for up to 1 day.
• Do not freeze whole blood specimens.
• Do not freeze and thaw the serum and plasma from Na+ heparin
specimens more than 3 times.
• Do not freeze and thaw plasma from Na+ citrate specimens more
than 1 time.
DIRECTIONS FOR USE
1) Prior to testing, the blood specimen and all components of the kit
must be equilibrated to room temperature 15°C – 30°C (59°F –
86°F). Mix the specimen before use.
2) Remove the cassette from the foil pouch and place on a clean and
level surface and use it within one hour.
3) For venous whole blood specimen:
Use the provided disposable pipette/ lab pipette to transfer 10µl
venous whole blood specimen directly onto the specimen well (S) of
the test cassette. Then add 2 drops of buffer (approximately 80µl) to
the buffer well (B) and start the timer. Read results at 10 minutes.
Do not interpret results after 20 minutes.
To use the provided disposable pipette:
a. The pipette provided with the test dispenses
approximately 10 µl in one drop even if more sample is
aspirated in the pipette.
b. Holding the disposable pipette vertically, squeeze the middle
of the disposable pipette between your thumb & index finger,
and touch the tip of the pipette to the sample.
c. Gently release the pressure to draw up 10μl of sample to the
fill line. Do not release the pressure completely. Ensure the
blood reaches the fill line with no air bubbles.
Squeeze the disposable pipette to transfer 1 drop of whole blood to
the specimen well (S) of the test cassette
4) For plasma or serum specimen:
a. For plasma specimen, use common anticoagulant, K
2
EDTA, Na+ Heparin or Na+ Citrate. Other anticoagulants
have not been validated and may cause a false result.
b. Separate serum or plasma from blood as soon as possible
to avoid hemolysis. Used only clear, non-hemolyzed, non-
lipemic specimens.
c. Use the provided disposable pipette/ lab micropipette to
transfer 10µl serum or plasma specimen directly onto the
specimen well (S) of the test cassette then add 2 drops of
buffer (approximately 80µl) to the buffer well (B) and start
the timer. Read results at 10 minutes. Do not interpret
results after 20 minutes.
5) For fingerstick whole blood specimen:
a. Wash the patient’s hand with soap and warm water or clean
the fingertip to be punctured with an alcohol pad. Allow to
dry completely.
b. Using a safety lancet, apply gentle pressure to puncture the
surface near the center of the fingertip. Wipe away the first
sign of blood.
c. Using the provided disposable pipette, collect fingerstick
whole blood specimen to the indicated fill line. Avoid
touching the disposable pipette directly to the finger.
d. Squeeze the disposable pipette to transfer 1 drop of whole
blood to the specimen well (S) of the test cassette. The