Diagnostics Lateral Flow Test Home Kit , Lateral Flow Rapid Antigen Test 10 Minutes
|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|
Diagnostics Lateral Flow Test Home Kit,
10 Minutes Lateral Flow Test Home Kit,
Diagnostics Lateral Flow Rapid Antigen Test
Diagnostics Lateral Flow Test Home Kit 10 Minutes
These rapid lateral flow tests are designed to detect large numbers of SARS-CoV-2 infectious cases in a short space of time to prevent further onward transmission. The rapid test is performed using nasopharyngeal swabs and is proven to give excellent accuracy (96.3%) with a sensitivity of 86.7% and a specificity of 100%.
The test is simple to administer and comes supplied with clear instructions and all the necessary equipment to carry out the test. This includes a workstation to lay out the contents of the pack in a way that helps workplaces deliver mass testing with ease and efficiency to help keep them safe and operating effectively.
Lateral flow test for rapidly detecting active infections
Visual, easy to read result in just 15 minutes
Tests can be administered anywhere, any time
Helps to minimise disruption to businesses
Ideal for businesses to regularly and reliably test staff
Approved by the UK government and Public Health England
In high demand from schools, councils and companies
High sensitivity and specificity
Sold in a pack of 20 for testing en masse
All necessary reagents provided and no additional equipment needed
Each kit includes clear instructions and is easy to use
24 month shelf life
Storage between 2 and 30°C
It is understood that as many as one in three people who have coronavirus do not show symptoms but are infectious. Lateral flow tests help to quickly identify and reduce the spread of the virus from those who appear healthy.
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 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.
4. Interference Substances
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,|