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COVID -19 New Coronavirus Antigen Rapid Test Kit ISO13485 / CE

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China Orient New Life Medical Co.,Ltd. certification
China Orient New Life Medical Co.,Ltd. certification
We are satisfied with your quality & services so far. The HIV 1/2 antibody Test performance is perfect.

—— Katrina

I have to say that New Life provides high quality products. The FOB, Troponin I, HIV, HCV, Drug Abuse test all performed very well in our market.

—— Clemen

Your Dengue IgG/IgM and Malaria test perfromed well. Now we want to try your Filariasis test in our market.

—— Primo

COVID -19 New Coronavirus Antigen Rapid Test Kit ISO13485 / CE

COVID -19 New Coronavirus Antigen Rapid Test Kit  ISO13485 / CE
COVID -19 New Coronavirus Antigen Rapid Test Kit  ISO13485 / CE COVID -19 New Coronavirus Antigen Rapid Test Kit  ISO13485 / CE

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Product Details:

Place of Origin: China
Brand Name: New Life
Certification: ISO13485,CE
Model Number: Cassette

Payment & Shipping Terms:

Minimum Order Quantity: 5000pcs
Packaging Details: 1pc/pouch, 25pcs/box
Delivery Time: 20-30days
Payment Terms: T/T, Western Union, MoneyGram
Supply Ability: 2000000pcs/month
Detailed Product Description
Category: Infectious Disease Format: Cassette
Specimen: Nasal Or Oral Swab Testing Time: 5-15 Minutes
Shelf Life: 24 Months Application: COVID-19 Antigen
Accuracy: 90%

Product Name:
COVID-19 New Coronavirus Antigen rapid screen Test Cassette

 

Accessories:
Instruction for use, buffer, pipette
Principle of Test:
Immunochromatographic assay

Intended Use:

The COVID-19 Antigen Rapid Test device is a lateral flow chromatographic immunoassay for the qualitative detection of the Novel coronavirus in human samples. It provides an aid in the diagnosis of infection with 2019-nCOV.

 

Summary

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.

 

TEST PRINCIPLE

The Device uses the principle of the double antibody sandwich method for detecting the nucleoprotein (N) of SARS-CoV-2. The marker is composed of the anti-N antibody 1 labeled with colloidal gold. When testing, the sample was added into the sample well and migrated to the absorbent pad by the capillary effect. If the virus exists, it will react with the marker and captured by the anti-N antibody 2 coated in the NC membrane. Then there is a colored line produced at the test area, indicating a positive result. If there is no virus in

the sample, the colored line will not show at the test area and it means a negative result. Regardless of whether the virus contained in the sample, as a procedural control, a colored line will always appear at the control area, indicating that proper volume of specimen has been added and the correct test procedure is conducted.

 

INTERPRETATION OF RESULTS

COVID -19 New Coronavirus Antigen Rapid Test Kit  ISO13485 / CE 0

Positive:

Two red lines are visible in the result window. The intensity of the test line may be

weaker or darker than that of the control line. This still means a positive result.

Negative:

The control line appears in the result window, but the test line is not visible.

Invalid:

If the control line does not appear in the result window, the test results are INVALID regardless of the presence or absence of the line in the test region.

 

COVID -19 New Coronavirus Antigen Rapid Test Kit  ISO13485 / CE 1

 

 

Contact Details
Orient New Life Medical Co.,Ltd.

Contact Person: Jerry Meng

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