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SARS-CoV-2 Antigen Rapid Test Kit(Fluorescence immunoassay)
SARS-CoV-2 Antigen Rapid Test Kit is a lateral flow immunoassay intended for the quantitative detection of the Nucleocapsid antigen from SARS-CoV-2 in nasopharyngeal swabs from individuals who are suspected of SARS-COV-2 by their healthcare provider within the first 7 days of symptom onset, or for screening of individuals without symptoms, or other reasons to suspect SARS-COV-2 infection, if applicable.
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 SARS-CoV-2 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 SARS-CoV-2, and confirmed with a molecular assay, if necessary, for patient management.
The SARS-COV-2 Antigen Rapid Test Kit is intended for use by trained clinical laboratory personnel specifically instructed and trained in vitro diagnostic procedures.
The SARS-CoV-2 Nucleocapsid proteins Rapid Test is a one-step chromatographic sandwich immunoassay designed for the quantitative measurement of SARS-CoV-2 Nucleocapsid proteins. The SARS-CoV-2 Nucleocapsid proteins in the sample was first bound with the conjugated compound of fluorescent labeled SARS-CoV-2 Nucleocapsid proteins monoclonal antibody, then moved and combined with another SARS-CoV-2 Nucleocapsid proteins monoclonal antibody fixed on the nitrocellulose membrane, and the double antibody sandwich complex was formed at the detection line of the cellulose nitrate membrane. The quantitative detection results were obtained by NIR-1000 dry fluoroimmunoassay analyser.
|Test cards||25||It is composed of fluorescent pad (coated with fluorescent labeled SARS-CoV-2 Nucleocapsid proteins monoclonal mouse antibody), nitrocellulose membrane (coated with SARS-CoV-2 Nucleocapsid proteins monoclonal mouse antibody and Goat anti mouse IgG antibody), absorbent paper and backing|
|Sample diluent||25(400μL/tube)||Phosphate buffer|
|Nasal Mid-Turbinate (NMT) swabs||25||Flocking|
|ID card||1||With specific stand curve file|
The components in different batches of kits cannot be used interchangeably.
【Storage conditions and validity】
The kit should be stored at 4℃~30℃, out of direct sunlight. It is valid for 18 months. The test card should be used within 15 minutes after unsealing under the environment of 15℃~30℃ and 20% ~ 90% relative humidity.
The production date, batch number and expiration date are shown in the outer package of the product.
Nir-1000 dry fluorescent immunoassay analyzer produced by WWHS Biotech. Inc.
Insert a fresh NMT swab into the patient nostril parallel to the palate. The swab should be inserted less than 1 inch/2cm into the nostril until resistance is met at the turbinate. Rotate the swab several times, then gently remove and repeat the process in the other nostril.
【Interpretation of results】
1) The test card can be used only once at room temperature, do not reuse or use test card out of expiry date.
2) Return all reagents and sample into room temperature before use.
3) Be careful when prepare sample, wear glove and mask.
4) The whole blood need add anticoagulants, not frozen; serum sample can store in frozen, avoid repeated freezing and thawing.
5) This product is only for in vitro rapid diagnostic human use, can not be quantified, only qualitative testing.
1. What is the MOQ?
Generally if you choose the different products, our minimum order qty. also will be different. One sample available.
2. What about the delivery time?
The goods need 7-21 work days to be made upon deposit.
3. Does your product have any warranty?
Yes, we offer 6 months limited warranty for our products.
Damage due to misuse, ill treatment and unauthorized modifications and repairs are not covered by our warranty.
4. What's your shipping method?
We provide comprehensive shipping methods.
For small quantity orders we ship by DHL Air-Express, or EMS/TNT/UPS/FEDEX Express service, it is safe and fast.
For large quantity orders we ship by Air transportation or sea transportation, we can also ship order to buyer’s cargo agent in China.
Send your inquiry directly to us