2019-nCoV Ag Saliva Rapid Test Kit Corona Saliva Antigen High Accurate
|Place of Origin:||China|
Payment & Shipping Terms:
|Minimum Order Quantity:||negotiable|
|Payment Terms:||T/T, Western Union|
|Sample Type::||Saliva||Key Words:||Saliva Antigen Rapid Test Kit|
|Using::||Self Test||Detection:||Nucleocapsid Protein Antigen From 2019 NCoV|
Corona Saliva Antigen Test Kit,
High Accurate Saliva Antigen Test Kit
Corona Saliva Antigen Test Kit High Accurate For Diagnostic Use
If you don’t like the idea of nasal or throat swabs tests, our new highly accurate Saliva tests could be the answer.
These lateral flow tests are accurate, fast, and comfortable to use, and more importantly, it eliminates the close contact with the examiners, reducing the risk of viral exposure.”
Our New COVID-19 Antigen test from dispenses with the unpleasant and sometimes painful nasopharyngeal swabs and can provide evidence of a possible COVID-19 outbreak within the office comfortably within 10minutes with only a little saliva with a gold standard specificity of 100% and a remarkable sensitivity of 94%.
Each Coronavirus Ag Colloidal Gold Saliva Lateral Flow Test includes all necessary reagents and requires no additional specialist equipment to conduct a successful COVID-19 test in only 10 minutes, this makes the test ideally suited for workplace testing schemes.
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
The Test Kit 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 Test Kit is intended for use by trained clinical laboratory personnel specifically instructed and trained in vitro diagnostic procedures.
This reagent 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 kits
|Buffer with tube||1||5||10||15||20|
|Instructions for use||1||1||1||1||1|
|Quick Reference Instructions||NA||1||1||1||1|
Note: The components in different batches of the kit cannot be mixed.
Materials required but not provided
STORAGE AND STABILITY
- Store the Test Kit as packaged between 2-30°C.
- The Test Kit is 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 Kit must remain in the sealed pouch until use.
- The saliva should be gently spitted in to oval mouth of the saliva collector.
- Do not eat, drink or smoke prior to the test for at least 30 minutes.
- The samples should be used as soon as possible after collected.
- Samples should not be inactivated.
- Take out the buffer tube, open the dripper cap.
- Gently turn the saliva collector and tighten it onto the buffer tube.
- Spit saliva into the oval mouth of the saliva collector,make the saliva flow into the tube completely until to 1000uL marker line.
- Remove the saliva collector.
- Close the dripper cup and tighten it.
- Shake the tube at least 10 times, make sure the saliva mixes well with sample buffer.
- Break the dripper head
Before test, please read the instruction manual.
- Take the sample buffer and test cassette to equilibrate to room temperature.
- Unpack the aluminum foil bag, place the test cassette horizontally on the table and mark it.
- Add 80μL (3 drops) of the processed sample to the sample well, and timed. Recommended to use a pipette to take buffer/samples to reduce deviations.
- As the test begins to work, the purple color move across the result window in the center of the test device.
- Wait for 10 minutes and read the results.
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 Kit.
- The result of the Test Kit 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.
- Test Kit 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 Kit 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 Kit was established with 242 sample collected from symptomatic patients, who with symptoms onset within 7 days.
Sensitivity: 95.04% (115/121), 95% CI (89.60,97.71)
Specificity: 98.54% (135/137), 95% CI (94.83, 99.60).
|2019-nCoV Ag Saliva Rapid Test Kit (Immunochromatography)||Comparative RT-PCR Test Result|
|Positive (+)||Negative (-)||Total|
The performance of Test Kit 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 Kit is higher with samples of a Ct count <25.
|2019-nCoV Ag Saliva Rapid Test Kit (Immunochromatography)||
(Positive by Ct Value)
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 Kit is 100 TCID50/mL
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 Kit 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 kit or saliva collector.
- Should never open the foil pouch of the Test Kit exposing it to the ambient environment until the Test Kit is ready for immediate use.
- Discard and do not use any damaged or dropped Test Kit 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 Kit 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 Card|
|Instructions for Use||Saliva Collector|
|Store at 2°C~30°C||Do Not Reuse|
|Expiration Date||Catalogue Number|
|Manufacturer||Keep away from Sunlight|
|Lot Number||Tests per Kit|
|Keep Dry||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,
Doc No.: DC-IN-0619C01 Ver 1.3