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CE Certificate COVID-19 IgG rapid test cassette

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China Hangzhou AllTest Biotech CO.,LTD certification
China Hangzhou AllTest Biotech CO.,LTD certification
I like the products and service provided by AllTest. They really take our interest into consideration.

—— Mr John Smith England

My oldest daughter actually has Lyme disease. She spent almost 1 year in a wheelchair because of Lyme. She is doing very well now. I used 2 of the samples. 1 to test my Lyme diagnosed daughter and 1 to test my daughter who does not have Lyme. Your tests worked well. My daughter with Lyme tested positive and the one who does not tested negative.

—— Ms Sheila

Whenever I have the requests,AllTest always give me the satisfied reply at the first time.

—— Mrs Julie Tschetter Belgium

As the old customer of AllTest since 2009, we should thank the great work have been done by AllTest to support us gain more market share and profit

—— Mr Robin Seifert Germany

CE Certificate COVID-19 IgG rapid test cassette

CE Certificate COVID-19  IgG rapid test cassette
CE Certificate COVID-19  IgG rapid test cassette

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Product Details:

Place of Origin: CHINA
Brand Name: AllTest
Certification: CE
Model Number: INCPG-402

Payment & Shipping Terms:

Minimum Order Quantity: 500
Packaging Details: 25T/kit
Supply Ability: 100 Million a year
Detailed Product Description
Format: Cassette Specimen: W / S / P
Cut-Off: See Insert Storage: 2-30℃
Shelf Time: 24 Months
High Light:

rapid diagnostic test kits

,

one step rapid test

The COVID-19 IgG Rapid Test Cassette is a lateral flow chromatographic immunoassay for the qualitative detection of IgG antibody to SARS-COV-2 in human whole blood, serum or plasma specimen, and also in Fingerstick Whole Blood specimen.

 

【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.

Coronaviruses are enveloped RNA viruses that are distributed broadly among humans, other mammals, and birds and that cause respiratory, enteric, hepatic, and neurologic diseases.1 Six coronavirus species are known to cause human disease.2 Four viruses — 229E, OC43, NL63, and HKU1 — are prevalent and typically cause common cold symptoms in immunocompetent individuals.2


【DIRECTIONS FOR USE】
Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.
1. Remove the test cassette from the foil pouch and use it within one hour. Best results will be obtained if the test is performed immediately after opening the foil pouch.
2. Place the cassette on a clean and level surface.
For Serum or Plasma specimen:
To use a dropper: Hold the dropper vertically, draw the specimen to the fill line
(approximately 10 μL), and transfer the specimen to the specimen well (S), then add 2 drops of buffer (approximately 80 uL), and start the timer.
To use a pipette: To transfer 10 uL of specimen to the specimen well(S), then add 2 drops of buffer (approximately 80 uL), and start the timer.
For Venipuncture Whole Blood specimen:
To use a dropper: Hold the dropper vertically, draw the specimen about 1 cm above the fill line and transfer 1 full drop (approx.20 μL) of specimen to the sample well(S). Then add 2 drops of buffer (approximately 80 μL) and start the timer.
To use a pipette: To transfer 20 uL of whole blood to the specimen well(S), then add 2 drops of buffer (approximately 80 uL), and start the timer.
For Fingerstick Whole Blood specimen:
To use a dropper: Hold the dropper vertically, draw the specimen about 1 cm above the fill line and transfer 1 full drop (approx.20 μL) of specimen to the sample well(S). Then add 2 drops of buffer (approximately 80 μL) and start the timer.
To use a capillary tube: Fill the capillary tube and transfer approximately 20 μL of fingerstick whole blood specimen to the specimen well (S) of test cassette, then add 2 drops of buffer (approximately 80 uL) and start the timer. See illustration below.
3. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 20 minutes.
Note: It is suggested not to use the buffer, beyond 6 months after opening the vial.

CE Certificate COVID-19  IgG rapid test cassette 0

 

INTERPRETATION OF RESULTS

IgG POSITIVE:* Two colored lines appear. One colored line should always appear in the control line region (C) and another line should be in the IgG line region.

*NOTE: The intensity of the color in the test line regions may vary depending on the

concentration of 2019-nCoV antibodies present in the specimen. Therefore, any shade of color in the test line region should be considered positive.

NEGATIVE: One colored line appears in the control line region (C). No line appears in the IgG region region.

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

Cat.No. Product Specimen Format Kit Size CE Status
INCPG-402 COVID-19 IgG Rapid Test WB/S/P Cassette 25 T CE

Contact Details
Hangzhou AllTest Biotech CO.,LTD

Contact Person: selina

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