At Home Rapid Test Kit 25 Tests Combined Antibody Throat Swabs And Sputum

Product Specification

• At Home Rapid Test Kit 25 Tests Combined Antibody Throat Swabs And Sputum
•  
• Rapid results in 2-5 minutes
• Small sample sizes
• Sold in packs of 100
• Detection Window IgM: Symptomatic 3-5 days, Asymptomatic 7 days
• Shelf life of 24 months from manufacture date
• Forensic/Professional Use Only
• Tests should be conducted by a licensed phlebotomist, or a medical professional
• Verification of use case prior to shipping is mandatory

Product Facts:

• Detection Window IgM: Symptomatic 3-5 days, Asymptomatic 7 days
• Sample: Test can work with whole blood, plasma and serum samples.
• Storage: The kit can be stored at room temperature or refrigerated (2-30°C).
• Shelf Life: 24 months from manufacture date
• More information, such as the product insert, clinical trial results, and CE documentation is available at request

How to USE

1. Remove the test cassette from the sealed foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
2. Place the test device on a clean and level surface.
3. (For Whole Blood Specimen): Hold the 5 μL mini plastic dropper vertically and transfer 1 drop of whole blood (about 10 μL) to the specimen well(S) of the test device, then add 2 drops (about 80 μL) of sample buffer to the buffer well (B) immediately. Avoid air bubbles.
4. Wait for the colored line(s) to appear. The result should be read in 10 minutes. Positive results may be visible as soon as 2 minutes. Do not interpret the result after 15 minutes.

IgM/IgG Rapid Test

It can be used for rapid screening of carriers of the virus that are symptomatic or asymptomatic. Recent studies suggest that a high percentage of patients show no clinical symptoms of the virus, thus screening patients is vitally important. The test is ideally suited for hospitals, clinics and test laboratories. The test can also be effectively deployed in businesses, schools, airports, seaports and train stations, etc., giving it the potential to become a compelling force in the fight against this global threat.

* This product is available for research use only and is not for use in diagnostic procedures in some countries.

Features & Benefits

Rapid IgM-IgG Combined Antibody Test is used to qualitatively detect IgG and IgM antibodies of the novel coronavirus in human serum, plasma or whole blood in vitro.

Precise

• Works with whole blood, serum, & plasma
• Tests for both IgM and IgG antibodies
• Validated using PCR

Fast

• 10 minutes per test
• Intuitive visual interpretation
• No special equipment needed

How It Works

Steps

1. Collect blood/serum/plasma sample.
2. Add blood/serum/plasma sample to sample well.
3. Place 2-3 drops of buffer in sample well.
4. Read results after 10 minutes.

Results

FAQs

1, What is IgM-IgG Rapid Test?

Rapid IgM-IgG Combined Antibody Test is a lateral flow immunoassay used to qualitatively detect IgG and IgM antibodies of the novel coronavirus in human serum, plasma or whole blood in vitro.

2, How does Rapid Test work?/ 

The test strip contains a colloidal gold-labeled recombinant novel coronavirus antigen and quality control antibody colloidal gold marker, two detection lines (G and M lines) and one quality control line (C) fixed on a nitrocellulose membrane. M is fixed with monoclonal anti-human IgM antibody for detecting the novel coronavirus IgM antibody. G is fixed with monoclonal antihuman IgG antibody for detecting the novel coronavirus

3, How quickly can Rapid Test yield results?

Results are valid 15 minutes after sample and buffer are combined in the cassette sample well.

4, How accurate is the Rapid Test?/ 

In order to test the detection sensitivity and specificity of the IgG-IgM combined antibody test, blood samples were collected from patients from multiple hospitals and Chinese CDC laboratories. The tests were done separately at each site. A total of 525 cases were tested: 397 (positive) clinically confirmed (including PCR test) SARS-CoV-2-infected patients and 128 non- SARS-CoV-2-infected patients (128 negative). The testing results of vein blood without viral inactivation were summarized in the Table 1. Of the 397 blood sample from SARS-CoV-2-infected patients, 352 tested positive, resulting in a sensitivity of 88.66%. Twelve of the blood samples from the 128 non-SARS-CoV-2 infection patients tested positive, generating a specificity of 90.63%.

5, What do the results tell me?

A total of three detection lines are possible, with the control (C) line appearing when sample has been flowed through the cassette.

(1) Negative Result: If only the quality control line (C) appears and the detection lines G and M are not visible, then no novel coronavirus antibody has been detected and the result is negative.

(2) Positive Result, M only: If both the quality control line (C) and the detection line M appears, then the novel coronavirus IgM antibody has been detected and the result is positive for the IgM antibody.

(3) Positive Result, G only: If both the quality control line (C) and the detection line G appears, then the novel coronavirus IgG antibody has been detected and the result is positive for the IgG antibody.

(4) Positive Result, G and M: If the quality control line (C) and both detection lines G and M appear, then the novel coronavirus IgG and IgM antibodies have been detected and the result is positive for both the IgG and IgM antibodies.

6, What are the alternatives?

The IgM/IgG Rapid Test can be used to screen patients suspected of having been affected by the novel coronavirus. However, results of test should not be the only basis for diagnosis. Results should be used in combination with clinical observations and other testing methods such as nucleic acid PCR test.