Where To Get Tested For Covid 19 Throat Swab Or Nasal Swab
Screening Test Coronavirus Ag Rapid Test Cassette Swab
COVID-19 Antigen Rapid Test Cassette
For the qualitative detection of SARS-CoV-2 antigen in human throat
swab or nasal swab
Main Features
☀ High Sensitivity, Some Products can reach 100%
☀ High Specificity, Some Products can reach 100%
☀ Reliable: High Accurate, Early Detection of The Presence Of Virus
☀ Convenient: Room Temperature Storage, patented Built-In Control
line for easy operation with high accuracy
☀ Fast: Results in 5-30 minutes, strong positive results may be
observed promptly within 3 minutes
☀ Simple: No complicated Instrument Required
☀ Certified by Authoritative Certification System and Standards
☀ Winner of "the National Rapid Diagnostic Kit for Clinical
Performance Assessment"
Principle
This kit uses double antibody sandwich immunoassay to detect
specific antigens to SARS-CoV-2 in human throat or nasal cavity.
The membrane was precoated with SARS-CoV-2 specific antibody on the
test zone and goat anti mouse IgG antibody on the control zone.
The complex moves forward on the membrane by the capillary action,
then the complex is captured by specific antibody to SARS-CoV-2 on
the test zone to produce a visual red color line. The color of line
is positive correlated with the amount of SARS-CoV-2 in specimen.
Regardless of the presence of SARS-CoV-2, as the mixture continues
to move across the membrane to the control zone, the complex is
captured by immobilized goat anti mouse IgG antibody to form a
distinct red line.
Intended Use
COVID-19 Antigen Rapid Test Cassette is for in vitro qualitative
detection of specific antigens to SARS-CoV-2 present in human
throat or nasal cavity. It cannot be used as the basis for the
diagnosis and exclusion of COVID-19.
This reagent is used to detect cases with suspected symptoms of
COVID-19 within 7 days. If suspected symptoms are more than 7 days,
it is recommended to test with COVID-19 antibodies or nucleic acid
reagents. The main clinical symptoms of COVID-19 are: Fever, dry
cough, fatigue, a few patients will have stuffy nose, runny nose
and diarrhea.
Reagents and Materials Provided
| Specification | 20 cassettes per kit | 1 cassette per kit |
| Component | 20 test cassettes | 1 test cassette |
| 20 desiccant bags | 1 desiccant bag |
| 20 sample extraction solution | 1 sample extraction solution |
| 20 sample collection tubes | 1 sample collection tube |
| 1 Instruction for use | 1 Instruction for use |
| 1 disposable sampling swab |
Materials Required But Not Provided
☀ Timer or stopwatch
☀ Biohazard disposal container
☀ Disposable gloves
☀ Disposable sampling swab
Swab Preparation (Throat / Nasal)
1. Remove the pointed nozzle cap out of the sample collection tube.
Twist and open the sample preservation solution tube, then add the
sample extraction solution into the sample collection tube.
2. Insert the patient swab into the sample collection tube. While
squeezing the buffer tube, stir the swab more than 5 times.
3. Remove the swab while squeezing the sides of the tube to extract
the liquid from the swab.
4. Press the pointed nozzle cap tightly onto the tube.
Sample Collection
1. Throat Swab Sample
Take a disposable sampling swab out, insert it into the throat of
the patient. Use the swab to gently wipe the pharyngeal tonsils on
both sides of the patient for at least 3 times, and then wipe them
on the posterior pharyngeal wall for at least 3times. Withdraw the
swab from the throat.
2. Nasal Swab Sample
Take a disposable sampling swab out, insert it into the nostril of
the patient. Carefully insert the swab into the nostril. Gently
rotating, pushing the swab until meet resistance at the level of
the turbinates (less than one inch into the nostril). Rotate the
swab several times against the nasal wall then remove it from the
nostril.
Interpretation of Results
☀ Positive: One color line in the control zone (C) and one color
line in the test zone (T). This indicates that the sample contains
SARS-CoV-2 antigen.
☀ Negative: Only one color line in the control zone (C). This
indicates that no SARS-CoV-2 antigen has been detected.
☀ Invalid: If no color line appears in the control zone (C), the
test is invalid. Discard the test cassette and perform with new
cassette.
Built-In Control
COVID-19 Antigen Rapid Test Cassette has a built-in procedural
control that demonstrates assay validity. A color line appeared on
the control zone (C) indicates that the test runs correctly.
Precautions
☀ This product is an in vitro diagnostic reagent to qualitatively
detect the SARS-CoV-2 antigen in human throat or nasal cavity.
☀ The reagent may cause false negative results in COVID-19 patients
with asymptomatic infection.
☀ Do not use the test if the pouch is damaged or the seal is
broken.
☀ Do not modify the test procedure.
☀ Do not touch the reaction zone of the reagent.
☀ Each test is for single use only.
Warning
For Medical Professional and In Vitro Diagnostic use ONLY
Read the package insert completely before use. It is very important
that the correct procedure is followed. Fail to add the patient
sample may lead to a false result.
Storage
COVID-19 Antigen Rapid Test Cassette should be stored in dark place
at 2~30°C for 24 months from the date of manufacture.
Keep the test cassette in sealed pouch until use. Once you have
taken the test cassette out of the pouch, use it immediately. Do
not use the test beyond the indicated expiration date.
