|Sample Type::||Saliva||Key Words:||IFU EN 2019 NCoV 19 Saliva Ag EASY Test|
|Using::||Self Test||Detection:||Nucleocapsid Protein Antigen From 2019 NCoV|
High Accuracy Rapid Antigen Test Kit,
Self Checking Rapid Antigen Test Kit
IFU EN 2019 NCoV 19 Saliva Ag EASY Test
The Test 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.
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.
SUMMARY AND EXPLANATION
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.
PRINCIPLE OF THE TEST
This test 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 AND COMPONENTS
Materials provided with the test
|Ingredients||Cassette||Instructions for use||Quick Reference Instructions|
Materials required but not provided
STORAGE AND STABILITY
- Store the test as packaged between 2-30°C.
- The Test stable until the expiration date printed on the outer packing, the product will be expired after 24 months.
- Do not use beyond the expiration date.
- Do not freeze any contents of the test
- The test must remain in the sealed pouch until use.
Before test, please read the instructions carefully.
- Take the cassette to equilibrate to room temperature.
- Unpack the aluminum foil bag, take out the cassette.
- Insert the absorber end of the cassette into mouth. Make sure cassette is horizontal statement.
- Actively swab the inside of the mouth and tongue to collect oral fluid.
- Remove the absorber end from the mouth when the purple color move across the result window in the center of the test device.
- Wait for 10 minutes and read the results.
*When sampling, gently hold it in mouth and let saliva naturally adsorb on the sponge.
*Do not eat, drink, or smoke prior to the test for at least 30 Minutes.
*Any saliva specimen is appropriate for testing but the saliva specimen collected in the morning, before mouth rinsed, eating or drinking, is recommended
INTERPRETATION OF TEST RESULTS
This product can only perform qualitative analysis on the detection object.
If both C and T lines are visible within 10 minutes, the test result is positive and valid.
If test area (T line) has no color and the control area displays a colored line, the result is negative and valid
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.
The test contains a built-in internal control in the test card. A color band appearing in the control region (C) is designed as an internal control. The appearance of the control line confirms that sufficient flow has occurred, and that the test card is working normally. If the control line does not appear within 10 minutes, it is considered an error in the test result and it is recommended to test again with the same sample and a new device.
- The result of the test 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.
- The Test 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.
- The test must be equilibrated to room temperature (18℃~26℃) before used, otherwise the results may be incorrect
- A negative test result may occur if the level of antigen in a sample is below the detection limit of the test.
- Failure to follow the Test Procedure may adversely affect test performance and/or invalidate the test result.
- React less than 10 minutes may lead a false negative result; React more than 10 minutes may lead a false positive result.
- Positive test results do not rule out co-infections with other pathogens.
- Negative test results are not intended to rule in other viral or bacterial infections.
- Negative results should be treated as presumptive and confirmed with a molecular assay.
- Clinical performance was evaluated with fresh samples.
- Users should test specimens as quickly as possible after specimen collection.
1. Clinical Verification
The performance of Test was established with 232 sample collected from symptomatic patients, who with symptoms onset within 7 days.
|2019-nCoV Saliva Ag EASY TEST||Comparative RT-PCR Test Result|
|Positive (+)||Negative (-)||Total|
|Sensitivity||93.91%, 95% CI (87.97,97.02)|
|Specificity||99.15%, 95% CI (95.32, 99.85)|
|Accuracy||96.55%, 95% CI (93.34, 98.24)|
Positive results broken down by days since symptom onset:
|Days since symptom onset||RT-PCR Positive (+)||2019-nCoV Saliva Ag EASY CHECK||PPA|
Positive results broken down by CT value:
|2019-nCoV Saliva Ag EASY TEST||Comparative RT-PCR Method|
|(Immunochromatography)||(Positive by Ct Value)|
|Positive (Ct<=25)||Positive (25<Ct)|
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.
Cross-reactivity of the test card was evaluated. The results showed no cross reactivity with the following specimen.
4. Interference Substances
The test results do not be interfered with the substance at the following concentration:
1. Test 10 replicates of negative and positive by using the reference materials of enterprises. The negative agreement and the positive agreement were 100%.
2. Test three different lots kits including positive and negative reference materials of enterprises. The negative results and the positive results were 100%
6. Hook Effect
The Test Card was tested up to 1.6 × 105 TCID50/ml of heat-inactivated 2019-nCoV strain and no high-dose effect was observed.
- For in vitro diagnostic use.
- Use appropriate precautions in the collection, handling, storage, and disposal of patient samples and used test contents.
- Use of Nitrile, Latex (or equivalent) gloves is recommended when handling patient samples.
- Do not reuse the used Test Card or saliva swab.
- Should never open the foil pouch of the Test Card exposing it to the ambient environment until the Test Card is ready for immediate use.
- Discard and do not use any damaged or dropped Test Card or material.
- Inadequate or inappropriate sample collection, storage, and transport may yield false test results.
- Sample collection and handling procedures require specific training and guidance.
- To obtain accurate results, do not use visually bloody or overly viscous samples.
- To obtain accurate results, an opened and exposed Test Card should not be used.
- Testing should be performed in an area with adequate ventilation.
- Wear suitable protective clothing, gloves, and eye/face protection when handling the contents of this test.
- Wash hands thoroughly after handling.
KEY TO SYMBOLS USED
|Materials Included||Test Cassette|
|Instructions for Use||Date of|
|Consult Instructions||Do Not Reuse|
|Store at 2°C~30°C||Catalogue Number|
|Expiration Date||Keep away from Sunlight|
|Manufacturer||Tests per Kit|
|Lot Number||In Vitro Diagnostic Medical Device|
|Guangzhou Decheng Biotechnology Co., LTD|
|Room 218, Building 2, No.68, Nanxiang Road, Science City, Huangpu District, 510000, Guangzhou P.R.China|
|CMC Medical Devices & Drugs S.L.|
|C/ Horacio Lengo Nº 18, CP 29006,|