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COVID-19 (SARS-Cov-2) Antibody IgG/IgM Rapid Test Device

Short Description:

COVID-19 IgG/IgM Rapid Test

A rapid test for the qualitative detection of antibodies (IgG and IgM) to SARS-CoV-2 in whole blood, serum, or plasma. For professional in vitro diagnostic use only.


Product Detail

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SUMMARY

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.

COMPONENTS OF THE TEST KIT

• Test Devices

• Buffer

• 5µL Disposable plastic pipette

• Lancets (for finger stick whole blood only)

• Alcohol pad (Optional)

• Package insert

DIRECTIONS FOR USE

Allow the test device, specimen, buffer, and/or controls to reach room temperature (15-30°C) prior to testing.

1. Bring the pouch to room temperature before opening. Remove the test device from the sealed pouch and use it as soon as possible.

2. Place the test device on a clean and level surface.

• For Serum or Plasma Specimens:

Using the provided 5µL disposable pipette, and transfer 1 drop of serum/plasma to the specimen well of the test device, then add 1 drop of buffer, and start the timer.

• For Whole Blood (Venipuncture/Fingerstick) Specimens:

Using the provided 5µL disposable pipette, and transfer 2 drops of whole blood

(approximately 20µL) to the specimen well of the test device, then add 1 drop of buffer, and start the timer.

Note: Specimens can also be applied using a micropipette.

3. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 15 minutes.

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PACKAGE

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CERTIFICATE

ISO / CE / FDA / TGA / MOH / Anvisa


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