colloidal gold particles.

During lateral flow, the complex will move along the nitrocellulose membrane t
COVID-19 Antigen Rapid Test (Colloidal gold)
and be captured by another SARS-CoV-2 monoclonal antibody on test line to show a red line. If SARS-
Instruction For Use CoV-2 antigens are not present, or present at very low levels, only a red C Line will appear.
1. Intended use
4. Reagents and materials provided
The COVID-19 Antigen Rapid Test is a colloidal gold immunochromatography intended for the
Table 1 Reagent and materials provided
qualitative detection of SARS-CoV-2 nucleocapsid protein in human nasal swabs, throat swabs or
saliva swabs. Components 1 test 20tests

Coronavirus disease 2019 (COVID-19) is a respiratory disease caused by SARS-CoV-2 containing a Test cassette 1 20

single-stranded, positive-sense RNA genome of around 27-32 kb. SARS-CoV-2 infections can be Extraction solution 1 20

symptomatic or asymptomatic and both symptomatic and asymptomatic infected persons can transmit Disposable swabs 1 20

SARSCoV-2. The main means of transmission is through respiratory droplets (sneezing, coughing, etc.) Instructions for Use 1 1

and contact (picking nostril with the hand in contact with the virus, rubbing eyes, etc.). Most patients
5. Materials required but not provided
with COVID-19 exhibit mild to moderate symptoms including fever , cough , shortness of breath ,
• Timer or stopwatch
muscle ache, sore throat, and headache. A small number of patients progress to severe pneumonia
and eventually develop acute respiratory distress syndrome , septic shock and/or multiple organ failure. 6. Storage and handling

2. Summary Store the kit at 2-30°C/ 36-86°F, out of direct sunlight, valid for 24 months. Do not freeze the kit.
The test device should be used within 60 minutes after opening the foil pouch. For expiration date,
Test results are for the identification of SARS-CoV-2 nucleocapsid antigen which is generally detectable
please refer to the product label.
in upper respiratory samples or lower respiratory samples during the acute phase of infection. The
positive results indicate the presence of viral antigens, but clinical correlation with patient history and 7. Specimen collection and storage
other diagnostic information is necessary to determine infection status. The positive results do not rule
7.1. Specimen collection:
out bacterial infection or co-infection with other viruses. Pathogens detected are not necessarily the
• Oropharyngeal swab specimen collection
main cause of disease symptoms. The negative results do not rule out SARS-CoV-2 infection and
should not be used as the sole basis for treatment or patient management decisions, including infection
control decisions. The patient's recent contact history, clinical history and presentation should determine
if negative results require confirmatory testing with PCR.

3. Principle of the procedure

This rapid test kit is based on colloidal gold immunochromatography assay. To begin the test, a swab
− The patient should tilt their head slightly upward, open their mouth wide and make a sound of
samples is inserted into the Tube. The liquid in tube interacts with the specimen and facilitates
"ah" to expose both pharyngeal tonsils.
exposure of the appropriate viral antigens to the antibodies used in the test. The liquid in tube now
− The disposable swab should be used to cross the tongue base. Wipe both pharyngeal tonsils
containing the specimen is added to the Sample Port of the COVID-19 Test Card. If there are SARS-
back and forth with slight force for at least three times, and then wipe the posterior pharyngeal
CoV-2 antigen in the extract, the antigen will bind to the SARS-CoV-2 monoclonal antibody labeled with
 wall up and down for at least three times. • Tighten tube lid and stand by.

• Nasopharyngeal swab specimen collection 7.3. Specimen storage

After treatment, the specimens can be stored at room temperature (15-30℃) for up to 24 hours, at 2-8℃
for up to 72 hours.

8. Assay procedure

Before using the reagent, operate it strictly according to the Instruction for Use to ensure the accuracy
of the results.
• The test should be operated at room temperature (15-30℃).
− Gently hold the patient’s head with one hand, carefully insert the swab into the nostril and
• Tearing the packaging of the aluminum foil pouch, take out the test device, and place it
slowly go deep along the bottom of the lower nasal passage.
horizontally on the test table.
− When the top of the swab reaches the back wall of the nasopharyngeal cavity, gently rotate it
• 3.Vertically invert the Extraction solution , add 3 drops vertically into the sample well of the test
for one round (pause for a moment once reflex cough), and then slowly remove the swab.
device.
• Anterior nasal swab specimen collection
• The test results should be interpreted within 15 to 30 minutes.
Note : A false negative or false positive results may occur if the test results is read before 15 minutes
or after 30 minutes.

9. Interpretation of test results

Positive Result (+)

A Positive result must show Both a C line and a T line. A positive result means that viral antigens from
COVID-19 were detected and the individual is positive for COVID-19.
− Tilt the patient's head back 70 degrees. While gently rotating the swab, insert swab less than Below are photos of actual positive tests. Please note that the T line may be faint.
one inch (about 2cm) into nostril (until resistance is met at the turbinates).
Negative Result (-)
− Rotate the swab five times against the nasal wall then slowly remove from the nostril.
• A Negative result will show ONLY a C line. A negative result means that viral antigens from
− Using the swab repeat the collection procedure with the second nostril.
COVID-19 were not detected and that the individual is presumed negative for COVID-19.
7.2. Sample Preparation • Please note that negative results do not rule out COVID-19.
• Remove one specimen extraction tube from the kit before testing.
• In case of negative test result: Continue to follow all social distancing recommendations and take
• Label the specimen extraction tube or write specimen number on it. protective measures. If suspicions of infection persist and/or your first test is negative, repeat the
• Dip the swab head into the extraction solution to the bottom of the bottle and gently rotate the
test after 1 - 2 days and consult your healthcare provider or local COVID-19 center.
swab clockwise or anticlockwise for about 10 times to dissolve the specimens in the solution as
Note: A negative result is presumptive and confirmation with a molecular assay, if necessary, for patient
much as possible.
management may be performed.
• Squeeze the tip of the swab along the inner wall of the specimen extraction solution to keep the
Invalid Result
liquid in the tube as much as possible, remove and discard the swab.
If there is no line, or if there is only a T line, the test is INVALID. Invalid result means that the test did
not function correctly. You will need to retest with a new test kit. If uponretesting, the test result is still prevalence of disease caused by SARS-CoV-2 is high.
invalid, contact your doctor or local COVID-19 center. Aninvalid result does not indicate if the individual 7) Monoclonal antibodies may fail to detect, or detect with less sensitivity, SARS-CoV-2 viruses that
did or did not have COVID-19 and should beRepeated. have undergone minor amino acid changes in the target epitope region.
8) Analysis of the possibility of false negative results:
a. Unreasonable specimen collection, transportation and processing, low virus titer in the
sample, no fresh sample lead to false negative results.
b. The mutation of viral gene may lead to changes in antigenic determinants, which lead to
negative results.
c. The research on the SARS-CoV-2 has not been completely thorough; the virus may mutate
and cause the differences for best sampling time (virus titer peak) and sampling location.
Therefore, for the same patient, we can collect samples from multiple locations or follow up
for multiple times reduce the possibility of false negative results.
10. Limitations
11. Analyze performance
1) The product is for in vitro diagnostic use only. The test should be used for the detection of SARS-
CoV-2 Antigen in oropharyngeal swab and nasal swab specimens only. 1) Compliance rate of positive control substances：

2) This test kit can only be used for the qualitative detection of SARS-CoV-2 antigens, and can’t 2) Tested with 6 positive control substances, the results are all positive（6+/6+）

determine the quantity of SARS-CoV-2 antigens in samples. 3) Compliance rate of nagetive control substances：

3) Individuals without symptoms that test negative should be tested again with at least 24 hours and 4) Tested with 12 negative control substances, the results are all negative（12-/12-）

no more than 48 hours between tests. Additional confirmatory testing with a molecular test for 5) Repeatability：

negative results may be necessary after second negative result for asymptomatic patients, if there 6) Repeat the test 10 times with the repeated nature control substances, the results are all

is a high likelihood of SARS-CoV-2 infection, such as in an individual with as close contact with positive and the color rendering is uniform

COVID-19 or with suspected exposure to COVID-19 or in communities with high prevalence of 7) limit of detection：

infection. Additional confirmatory testing with a molecular test for positive results may also be a. limit of detection: 1.6×102 TCID50/mL.

necessary, if there is a low likelihood of SARS-CoV-2 infection, such as in individuals without b. Select the confirmed inactivated SARS-CoV-2 medium, (concentration 3.4×105

known exposures to SARS-CoV-2 or residing in communities with low prevalence of infection. TCID50/mL), use gradient dilution method to find out the virus medium to reach the critical

4) Positive test results do not exclude co-infection with other pathogens. value of the detection. Repeat the action for 20 times and the test result is positive for at

5) False negative results may occur when the SARS-CoV-2 antigen level in the sample is lower than least 19 times.

the detection limit of the kit or the specimen collection and transportation are not appropriate. 12. Clinical performance
Therefore, even if the test results are negative, the possibility of SARS-CoV-2 infection can’t be
The COVID-19 Antigen Rapid Test was conducted in prospective studies with samples of 209 individual
ruled out.
symptomatic patients (within 5 days of onset) and asymptomatic patients suspected of COVID-19.
6) Positive and negative predictive values are highly dependent on prevalence rates. Positive test
Sensitivity,specificity and correlation between the two methods were as follows:
results are more likely to represent false positive results during periods of little/no SARS-CoV-2
Sensitivity：98.0%（95% CI:92.4%~99.7%）
activity when disease prevalence is low. False negative test results are more likely when
Specificity：99.0%（95% CI:94.2%~100.0%）
Accuracy：98.8%（95% CI:91.8%~99.9%）

Reference PCR Results

TRX’s Results
Positive Negative Total

Positive 100 1 101

Negative 2 106 108

Total 102 107 209

13. Warnings and precautions

1) The kit is only for in vitro diagnosis.

2) This kit can only be used to detect SARS-CoV-2 antigen, not any other virus or pathogen.
3) The reagents should be stored according to the requirements of storage conditions, and should
be used within the validity period.
4) Do not open the aluminum foil bag before testing. If the aluminum foil bag is damaged or damp,
stop using it immediately.
5) Do not use the reagent that has exceeded the validity period of the kit label.
6) Test results are meant to be visually determined.
7) In order to avoid wrong results, sample collection and reagent testing should be carried out in
strict accordance with the instructions.
8) Do not reuse any kit components.
9) Correct sample collection, storage and transportation can ensure the correct test results.
Xiamen TongRenXin Biotech Co., Ltd.
Address: Building 4, Xiamen Biomedical Industry Collaborative Innovation and
Entrepreneurship Center, 71 Houxiang Road, Haicang District, Xiamen, China
Tel: +86-592-6539929
Email: trx_xm@xmtrx.com