1. This package insert must be read completely before performing
the test. Failure to follow directions in package insert may yield
inaccurate test results.
2. For professional in vitro diagnostic use only. Do not use after
expiration date.
3. Do not eat, drink or smoke in the area where the specimens or
kits are handled.
4. Do not use test if pouch is damaged.
5. Handle all specimens as if they contain infectious agents.
Observe established precautions against microbiological hazards
throughout in the collection, handling, storage, and disposal of
patient samples and used kit contents.
6. Wear protective clothing such as laboratory coats, disposable
gloves and eye protection when specimens are assayed.
7. Wash hands thoroughly after handling.
8. Please ensure that an appropriate amount of samples are used for
testing. Too much or too little sample size may lead to deviation
of results.
9. Sterile Swabs for the collection of Nasopharyngeal specimen and
Nasal specimen are different, Do not mix the using of the two types
of sampling swabs.
10.Viral Transport Media (VTM) may affect the test result;
extracted specimens for PCR tests cannot be used for the test.
11.The used test should be discarded according to local
regulations.
12.Humidity and temperature can adversely affect results.
SPECIMEN COLLECTION, TRANSPORT AND STORAGE
Nasopharyngeal Swab Specimen Collection
1. Insert a sterile swab into the nostril of the patient, reaching
the surface of the posterior nasopharynx.
2. Swab over the surface of the posterior nasopharynx.
3. Withdraw the sterile swab from the nasal cavity.
Nasal Swab Specimen Collection
1. Insert a sterile swab less than one inch (about 2 cm) into a
nostril (until resistance is met at the turbinates).
2. Rotate the swab 5-10 times against the nasal wall. Using the
same swab repeat the collection procedure with the second nostril.
3. Withdraw the sterile swab, avoid excess volume and high-viscous
nasal discharge.
Caution:
If the swab stick breaks during specimen collection, repeat
specimen collection with a new swab.
Specimen transport and storage
Specimens should be tested as soon as possible after collection. If
swabs are not been processed immediately, it is highly recommended
the swab sample is placed into a dry, sterile, and tightly sealed
plastic tube for storage. The swab specimen in dry and sterile
condition is stable for up to 24 hours at 2-8°C.
DIRECTIONS FOR USE
Allow the test, extracted specimen and/or controls to equilibrate
to room temperature (15-30°C) prior to testing.
1. Remove the test cassette from the sealed foil pouch and use it
within one hour. Best results will be obtained if the test is
performed immediately after opening the foil pouch.
2. Invert the specimen extraction tube and add 3 drops of extracted
specimen (approx.75-100μl) to the specimen well(S) and then start
the timer.
3. Wait for the colored line(s) to appear. Read the result at 15
minutes. Do not interpret the result after 20 minutes.
POSITIVE:* Two distinct colored lines appear. One colored line
should be in the control region (C) and another colored line should
be in the Test region (T). Positive result in the Test region
indicates detection of SARS-CoV-2 antigens in the sample.
*NOTE: The intensity of the color in the test line region (T) will
vary based on the amount of SARS-CoV-2 antigen present in the
sample. So any shade of color in the test region (T) should be
considered positive.
NEGATIVE: One colored line appears in the control region (C). No
apparent colored line appears in the test line region (T).
INVALID: Control line fails to appear. 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 kit
immediately and contact your local distributor.
SUMMARY
The novel coronaviruses belong to the β genus. COVID-19 is an acute
respiratory infectious disease. People are generally susceptible.
Currently, the patients infected by the novel coronavirus are the
main source of infection; asymptomatic infected people can also be
an infectious source. Based on the current epidemiological
investigation, the incubation period is 1 to 14 days, mostly 3 to 7
days. The main manifestations include fever, fatigue and dry cough.
Nasal congestion, runny nose, sore throat, myalgia and diarrhea are
found in a few cases.
