COVID-19 IgG/IgM Rapid Test Kit - Coronavirus Test Kits - Coronavirus Detection Kit - FDA EUA Authorized

COVID-19 IgG/IgM Rapid Test Kit Highlights

• Buy a coronavirus testing kit, offers a longer shelf life of up to 24 months from the date of purchase of manufacturers.
• IgG/IgM corona test kit ensures the 100% accurate results within a few minutes.
• The small sample size is adequate to pass or fail the COVID-19 Rapid test.
• The minimum of the 100 test purchasing is mandatory to enjoy the cost-effectiveness of a coronavirus detection kit along with the free disposable lancets.
• This Rapid Test Kit has been issued an EUA designation from the FDA.

Safety Instructions

Keep the Rapid COVID-19 testing kit away from the children. If not use the rapid test kits for Coronavirus, keep it in the sealed pouch. Do not use the device after the expiration date. Try to store at the room temperature of 2-30°C.

Warning 

• The corona test cassette is equipped for the professionals and forensic use only.
• Do not turn on the air-conditioner, electric fans during the test.
• Wear disposable gloves, laboratory clothes, and eye protection glasses.
• Do not use the broken and damaged pouches.

In the Box

Each rapid test kits for Coronavirus comes with 100 sealed pouches, 100 single-use lancet finger sticks including a dropper, a test cassette, one buffer, and one package insert.

Things Not Included in the COVID-19 IgG/IgM Rapid Test

The IgG/IgM Corona test kit does not contain any Centrifuge (for plasma), Dispensing bulb (for fingerstick whole blood only) and Heparinized capillary tubes. All these essentials are required to make a successful coronavirus detection test.

Principle of COVID-19 Rapid Test

The 2019 Novel “Coronavirus” COVID-19 Rapid Test Cassette (Serum/Plasma/Whole Blood) or lateral flow device (LFD) uses the test line IgG (anti-human IgG), test line IgM (anti-human IgM antibody), control line C (goat anti-rabbit IgG) immobilized on a strip of nitrocellulose. The burgundy color or dark reddish-purple conjugating comprises gold colloidal conjugated with rabbit IgG-conjugates and colloid gold (2019-nCOV conjugates). When added to a sample well with an assay buffer, the Rapid COVID-19 testing kit checks the presence of IgM/IgG antibodies. If both the IgG and IgM are found in the specimen, the 2019-nCOV will attach the immune-response forming proteins to the conjugates. The capillary action helps the process travel through the nitrocellulose membrane. When this process or complex crosses the line of the corresponding immobilized anti-human IgG/IgM antibodies, it starts forming the burgundy colour line to ensure the reactive test result. The absence of the colored band in the COVID-19 coronavirus instant testing kit suggests that the results are non-sensitive. 

COVID-19 IgG/IgM Rapid Test Usage Guidelines

Collect Specimen with Micropipette (Using Plasma, Serum, and Venous Whole Blood)

Buy a Coronavirus testing kit for the collection of 10ul of human venous whole blood, plasma, and serum using a micropipette, lancet, or any other small tools for laboratory use.

Collect Specimen with Micropipette (Using Capillary Whole Blood)

The manufacturers of coronavirus test kits offer the finger-use lancet to collect the 10ul of a capillary blood sample for COVID-19 rapid test.

Add collected specimen in COVID-19 IgG/IgM Rapid Test kit (for Plasma, Serum, and Venous Whole Blood)

Hold the COVID-19 Rapid Test cassette carefully to add the collected plasma, whole blood, or serum in the device.

Add collected specimen in COVID-19 IgG/IgM Rapid Test kit (for Capillary Whole Blood)

After collecting the whole capillary blood with a lancet, you can add the sample in the COVID-19 rapid testing kit.

Put the drops in buffer well (Using Plasma, Serum, and Venous Whole Blood)

The Corona test kit buffer well is used to place the 90ul or three drops of buffer into the vertical position.

Use buffer well to put the drops (Using Capillary Whole Blood)

Add the three drops or 90ul of whole capillary blood vertically into the buffer well of the coronavirus detection kit.

Wait for Reading (Process for Same both Capillary whole Blood, Plasma, Serum)

The Rapid COVID-19 testing Kit produces the results within 2-5 minutes. Make sure to check on time; otherwise, after 10-15 minutes it will show the fake reading.

LIMITATIONS

1. Use fresh samples only.
2. This test has been reviewed by the FDA.
3. Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus.
4. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
5. Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
6. Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E. Some specimens containing unusually high titer of heterophile antibodies or rheumatoid factor may affect expected results.
7. Not for the screening of donated blood