Antigen Saliva Rapid Test Card Instrument Free For Healthcare
|Place of Origin:||China|
Payment & Shipping Terms:
|Minimum Order Quantity:||negotiable|
|Payment Terms:||T/T, Western Union|
|Sample Type::||Saliva||Key Words:||2019 NCoV Ag Saliva Rapid Test Card|
|Using::||Self Test||Detection:||Nucleocapsid Protein Antigen From 2019 NCoV|
Saliva Rapid Test Card Instrument Free For Healthcare,
Instrument Free Saliva Rapid Test Card
2019 nCoV Ag Saliva Rapid Test Card
Rapidly tests for an active COVID-19 infection
Carried out by collecting oral swabs (saliva) - no swab required
Visual, easy to read result in just 15 minutes
High sensitivity and specificity
Ideal for carrying out widespread and repeated testing in working environments where employees are unable to carry out their role at home, this “no swab” saliva test ensures high compliance to test for an active COVID-19 infection. It is easy to administer on-site and enables vital workforces such as manufacturing firms, delivery drivers, probation staff and healthcare service providers to continue to operate safely and effectively.
The test identifies infected individuals in just 15 minutes to increase protection against the threat of coronavirus and minimise disruption to businesses. It has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA), with an accuracy of 98.1% and both high specificity and sensitivity.
Each kit is individually packaged and comes supplied with clear instructions and all the necessary equipment to carry out the test.
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.
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 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 AND COMPONENTS
Materials required but not provided
STORAGE AND STABILITY
- Store the test card as packaged between 2-30°C.
- The Test Card 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 card must remain in the sealed pouch until use.
- Insert the sponge end of the saliva swab into mouth. Actively swab the inside of the mouth and tongue to collect oral fluid.
- Remove the saliva swab from the mouth when the sponge fill with saliva and become soft, Or the indicator turns blue.
- 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.
*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.
- Take the test card to equilibrate to room temperature.
- Unpack the aluminum foil bag, place the test card horizontally on the table and mark it.
- 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.
- 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 card.
- 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.
- 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.
- The test card 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 Card was established with 243 sample collected from symptomatic patients, who with symptoms onset within 7 days.
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.
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,|