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Weihai Kangzhou Biotechnology Engineering Co.,Ltd
serena@whkangzhou.com
+86-0631-5678885
Model No.: Cassette
Brand: Kangzhou
Place Of Origin: China
Type Of Disinfection: Ozone
Functional Use: Diagnostic Instruments
Inventory: Yes
Shelf Life: 2 Years
Material: Pvc
Product Quality Certification: Ce, Tuv
Medical Device Classification: Class Iii
Safety Standard: None
Scope: Point of Care Testing
Test Time: 10-15mins
Sensitivity: 90.47%
Certificate: CE , ISO13485
Size: 4.0mm
Packaging: 1pc/box , 540boxes /carton
Productivity: 200,000pcs /day
Transportation: Ocean,Land,Express,Air
Place of Origin: Weihai
Supply Ability: 200,000pcs/day
Certificate: ISO 13485. Bfarm and PEI
HS Code: 3822190020
Port: Weihai ,Qingdao ,Shanghai
Payment Type: T/T
Incoterm: FOB,CFR,CIF,EXW
Saliva Midstream Test【PRODUCT PERFORMANCE】
Limit of detection (LoD)
The limit of detection (LoD) of the COVID-19 Antigen Rapid test (Saliva Test) was established using serial dilutions of concentrated inactivated virus samples. The specimens were diluted with the prescribed diluent in triplicate. Each series of diluted specimen was evaluated with twenty separate test cassettes. The LoD was determined as the lowest virus concentration that equal to or greater than 95% of the results were positive.(i.e., the concentration at which at least 19 out of 20 replicates tested positive).
The LoD of testing Gamma-Irradiated SARS-CoV-2 virus lysate is 60 TCID50/mL.
Since the first outbreak reported in December 2019, SARS-CoV-2 has spread rapidly worldwide,and the disease it causes has been named “Coronavirus Disease 2019” (COVID-19). Due to its highly contagious nature and global health crises, SARS-CoV-2 has been designated as a pandemic by the World Health Organization (WHO). SARS-CoV-2 continues to have devastating impacts on health care systems and the world economy including the U.S. To effectively end the SARS-CoV-2 pandemic, systematic screening and detection of both clinical and asymptomatic COVID-19 cases is critical. Particularly, the identification of subclinical or asymptomatic cases is important to reduce or stop the infection because these individuals may transmit the virus. As a point-of-care test with a 15 min testing time, COVID-19 Antigen test allows effective screening of COVID-19 infection on a large scale.
【INTENDED USE】
Covid-19 Antigen Rapid Test (Saliva Test) is a lateral flow immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in Saliva samples from individuals suspected of COVID-19.
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 other bacterial or viral infections.
Negative results from patients with symptom onset beyond seven days should be confirmed with a molecular assay. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management 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.
The product is intended to be used in any laboratory and non-laboratory environment that meets the requirements specified in the Instructions for Use and local regulations. For in vitro diagnostic use only.
Perform the test
1. Deeply cough 3~5 times. Note: Please cover your mouth and nose with a mask or tissue paper and keep distance from other people.
2. Remove the cassette device from the sealed pouch and take the blue cap off gently by holding the sides to expose the collection pad.
3. Hold the device on the part opposite to the collection pad and place the collection pad into the mouth.
4.Rub the collection pad against the cheek and tongue gently in a circular motion 10 times. Then keep the collection pad in the mouth for about 1~2 minutes.
5.Check if the C line appears at the C region in the result reading window. If not, please repeat step 4 until a C line is visible or the total in-mouth time of the collection pad exceed 10 minutes.
6.Lay the device on a clean, flat surface with the result reading window upward and keep the collection pad untouched for 10-15 minutes. Please use a time device for timing.
7.Read the results between 10-15 minutes. Note: The result might be visible after a shorter time, however, it should only be interpreted between 10-15 minutes.
Product Categories : COVID-19 Antigen Rapid Test > COVID-19 Antigen Rapid Test-saliva Swab
Privacy statement: Your privacy is very important to Us. Our company promises not to disclose your personal information to any external company with out your explicit permission.
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Privacy statement: Your privacy is very important to Us. Our company promises not to disclose your personal information to any external company with out your explicit permission.