Covid-19 test Saliva Rapid Test (Lollipop Test)

DC-IN-0589C01 Ver 1.6
2019-nCoV Ag Saliva Rapid Test Card
(Immunochromatography)
Catalog Number:
0589C4X001 0589C4X005 0589C4X010 0589C4X015 0589C4X020
INTENDED USE
SUMMARY AND EXPLANATION
PRINCIPLE OF THE TEST
MATERIALS AND COMPONENTS
STORAGE AND STABILITY
TEST PROCEDURE
LIMITATIONS
INTERPRETATION OF TEST RESULTS PERFORMANCE CHARACTERISTIC
SAMPLE REQUIREMENTS
The Test Card is a lateral flow immunoassay intended for the qualitative detection of
nucleocapsid protein antigen from 2019-nCoV in saliva specimens directly collected from
individuals who are suspected of COVID-19 by their healthcare provider within the first 7 days
of symptom onset.
Results are for the identification of 2019-nCoV nucleocapsid protein antigen. Positive results
indicate the presence of viral antigens, but clinical correlation with patient history and other
diagnostic information is necessary to determine infection status. Positive results do not rule
out bacterial infection or co-infection with other viruses. The agent detected may not be the
definite cause of disease.
Negative results should be treated as presumptive, and do not rule out 2019-nCoV infection
and should not be used as the sole basis for treatment or patient management decisions,
including infection control decisions. Negative results should be considered in the context of
a patient’s recent exposures, history, and the presence of clinical signs and symptoms
consistent with COVID-19, and confirmed with a molecular assay, if necessary, for patient
management.
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.
This Card uses double-antibody sandwich to legally detect the antigen of novel coronavirus
(2019-nCoV) in saliva samples. During detection, the gold labeled anti-2019-nCoV
monoclonal antibody in the labeling pad binds to the 2019-nCoV antigen in the sample to form
a complex, and the reaction complex moves forward along the nitrocellulose membrane
under the action of chromatography, it is captured by the anti-2019-nCoV monoclonal
antibody pre-coated by the detection zone (T) on the nitrocellulose membrane, and finally a
red color reaction line is formed in the T zone. If the sample does not contain 2019-nCoV
antigen, a red color reaction line cannot be formed in the T zone. Regardless of whether the
sample to be tested contains 2019-nCoV antigen, a red reaction line will always form in the
quality control area (C).
Materials provided with the test kits
Materials required but not provided
1. Timer
Specifications
Ingredients
0589C
4X001
0589C
4X005
0589C
4X010
0589C
4X015
0589C
4X020
Test Card 1 5 10 15 20
Saliva Swab 1 5 10 15 20
Instructions for
use 1 1 1 1 1
Quick
Reference
Instructions
NA 1 1 1 1
1. Store the test card as packaged between 2-30°C.
2. The Test Card is stable until the expiration date printed on the outer packing, the product
will be expired after 24 months.
3. Do not use beyond the expiration date.
4. Do not freeze any contents of the test.
5. The test card must remain in the sealed pouch until use.
1. Insert the sponge end of the saliva swab into mouth. Actively swab the inside of the mouth
and tongue to collect oral fluid.
2. Remove the saliva swab from the mouth when the sponge fill with saliva and become soft,
or the indicator turns blue.
3. Do not eat, drink or smoke prior to the test for at least 30 Minutes.
4. The samples should be used as soon as possible after collected.
5. Samples should not be inactivated.
NOTE:
*When sampling, gently hold it in mouth and let saliva naturally adsorb on the sponge.
*Don`t bite the sponge with teeth.
*Any saliva specimen is appropriate for testing but the saliva specimen collected in the
morning, before mouth rinsed, eating or drinking, is recommended.
Before test, please read the instructions carefully.
1. Take the test card to equilibrate to room temperature.
2. Unpack the aluminum foil bag, place the test card horizontally on the table and mark it.
3. Insert the saliva swab into the test card holder and push down saliva swab. The bump at
the end of the saliva swab must be into the hole of the test card holder.
4. As the test begins to work, the purple color move across the result window in the center of
the test device.
5. Wait for 10 minutes and read the results.
This product can only perform qualitative analysis on the detection object.
Positive Result􀄟
If both C and T lines are visible within 10 minutes, the test result is positive and valid.
Negative Result􀄟
If test area (T line) has no color and the control area displays a colored line, the result is
negative and valid.
Invalid Result􀄟
The test result is invalid if a colored line does not form in the control region. The sample must
be re-tested, using a new test card.
Positive Negative Invalid
1. The result of the test card should not be taken as a confirmed diagnosis, for clinical
reference only. Judgement should be made along with RT-PCR results, clinical symptoms,
epidemiological information and further clinical data.
2. Test Card performance depends on the amount of virus (antigen) in the sample and may or
may not correlate with viral culture results performed on the same sample.
3. The test card must be equilibrated to room temperature (18􀂥~26􀂥) before used,
otherwise the results may be incorrect
4. A negative test result may occur if the level of antigen in a sample is below the detection
limit of the test.
5. Failure to follow the Test Procedure may adversely affect test performance and/or
invalidate the test result.
6. React less than 10 minutes may lead a false negative result; React more than 10 minutes
may lead a false positive result.
7. Positive test results do not rule out co-infections with other pathogens.
8. Negative test results are not intended to rule in other viral or bacterial infections.
9. Negative results should be treated as presumptive and confirmed with a molecular assay.
10. Clinical performance was evaluated with fresh samples.
11. Users should test specimens as quickly as possible after specimen collection.
1. Clinical Verification
The performance of Test Card was established with 243 sample collected from symptomatic
patients, who with symptoms onset within 7 days.
2019-nCoV Ag Saliva
Rapid Test Card
(Immunochromatography)
Comparative RT-PCR Test Reslt
Positive
(+)
Negative
(-)
Total
Detected Positive 110 2 112
Detected Negative 5 126 131
Total 115 128 243
Sensitivity 95.65%, 95% CI (90.22,98.13)
Specificity 98.44%, 95% CI (94.48, 99.57).
Accuracy 97.12%, 95% Cl (94.17,98.60)
The performance of Test Card with positive results stratified by the comparative method cycle
threshold (Ct) counts were collected and assessed to better understand the correlation of
assay performance to the cycle threshold, As presented in the table below, the positive
agreement of the Test Card is higher with samples of a Ct count <25.
2019-nCoV Ag Saliva
Rapid Test Card
(Immunochromatography)
Comparative RT-PCR
Method
(Positive by Ct Value)
Positive>25
(Ct<=25)
Positive
(Ct>25)
Detected Positive 91 19
Total 92 23
Positive agreement 98.91% 82.60%
2. Limit of Detection
The experimental results show that for the virus culture concentration above 100 TCID50/mL,
the positive rate of detection is greater than or equal to 95%. For the virus culture
concentration of 50 TCID50/mL and below, the positive rate of detection is lower than 95%. So,
the limit of detection of the Test Card is 100 TCID50/mL.
3. Cross-reactivity
Cross-reactivity of the test card was evaluated. The results showed no cross reactivity with
the following specimen.
1 2 3 4 5