Coronavirus Test Kit

COVID-19 IgM/IgG Rapid Test

Rapid Coronavirus Covid-19 Serology test

This Product is included in the Australian Register of Therapeutics Goods (ARTG) number 332742

Our new Coronavirus (Covid-19) Rapid Serology IgM / IgG test is a diagnostic test for the determination of COVID-19’s IgM and IgG antibodies in human whole blood (from vein or fingertip), serum or plasma.

It is a simple and easy to use test with results available after 15 minutes. It is intended for use by healthcare professionals and clinical labs only.

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*Intended for use by healthcare professionals and clinical labs only

*This test has been assessed in terms of accuracy, manufacturing standards and reliability.

* This test is 100% specific for the Coronavirus.

*The correct interpretation of test results in conjunction with the clinical presentation of a patient is critical to informing patient management and minimisation of further transmission of the virus. Accurate identification of a COVID-19 infection based on serology results, particularly those obtained from rapid tests used at the point of care, requires an understanding of the antibody response profile. There is a window period between virus infection and the production of IgM and IgG antibodies, and the sensitivity and specificity of IgM/IgG antibody tests early in SARS-CoV-2 infection, is as yet, not well characterised. Accuracy as per manufacturer’s clinical performance: infection time 4-10 days is 94.6%, infection time 11-24 days – 99.3%. Transmission-based precautions must also be used when collecting specimens from patients with a communicable disease.

* Accuracy as per manufacturer’s clinical performance: infection time 4-10 days is 94.6%, infection time 11-24 days – 99.3%. It takes about 4 days to develop antibodies against the virus. Hence if a person being in early days tests negative, it is best to test again after 3-4 days to ensure results.

* This test does not replace the PCR laboratory tests, it complements them.

Steps for a Single Test:

10ul

Add 10 μL specimin

Apply 10μL whole blood (from vein or fingertip), serum or plasma onto the sample well of a Test Device.

2-drop

Add two drops of buffer

Then apply 2 drops (about 60-80μL) of buffer onto the sample well of a Test Device.

15-min-3

Wait 15 minutes

Read the result after 15 minutes. Do not read result after 20 minutes.

Interpretation of results

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Positive

negative-img

Negative

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Invalid

If quality control line C does not show color, this sample needs to be retested.

Specifications

Product Name VivaDiagTM COVID-19 IgM/IgG Rapid Test
Test Principle Colloidal gold
Sample Type Whole blood (from vein or fingertip), serum or plasma
Sample Value 10 μL
Test Time 15 Min
Operation Temperature 18-25c
Storage Temperature 2-30℃
Shelf Life (Unopened) 12 months


Composition

Each test kit contains the test device, buffer, pipette (optional) and package insert.

Materials required but not provided: safety lancet (for fingertip blood), alcohol pad, timer

Storage and Handling

  • Store the test kit in a cool, dry place between 2-30°C (36-86°F). Keep away from light. Exposure to temperature and / or humidity outside the specified conditions may result in inaccurate results.
  • Do not freeze or refrigerate.
  • Use the test kits at temperatures between 18-25°C.
  • Use the test kits between 10-90% humidity.
  • Do not use your test kits beyond the expiry date (printed on the foil pouch and box label).

Note: The test kit is recommended to store between 2-8°C if it not used in a short time. All expiry dates are printed in Year-Month format. 2021-06 indicates June, 2021

Test Procedure

  • . Take out the test kit and leave it at room temperature for minimum 30 minutes.
  • Put a test device on a dust-free clean surface.
  • Apply 10μL whole blood (from vein or fingertip), serum or plasma onto the sample well of a Test Device, and then apply 2 drops (about 60-80μL) of buffer onto the sample well of a Test Device.
  • Read the result after 15 minutes.

Note:

  • For in vitro diagnostic use.
  • Avoid contact with eyes and skin. Flush abundantly with water upon disposal if reagents are spilled.
  • If you apply fingertip blood with pipette, please wipe the rest of blood on the fingertip with alcohol pad.

Limitations

  • The test result can not be used for diagnosis of COVID-19. If the result does not match the clinical evaluation, please do more testing.
  • Please do not use highly hemolytic samples .
  • Please do not reuse the test device.
  • The test kit can only be used with whole blood (from vein or fingertip), serum or plasma. If use other samples, it may cause wrong results.
  • Please make sure read the result at 15 minutes. If at other time, it may cause wrong results.
  • Please follow the package insert when testing

Performance

From the results of 350 negative and positive samples, we can confirm that VivaDiagTM COVID-19 IgM/IgG rapid test has good clinical performance.

 

Clinical Performance of negative sample

Negative Cases (By PCR&CT) Negative coincidence rate (VivaDiagTM COVID-19 IgM) Negative coincidence rate (VivaDiagTM COVID-19 IgG) Negative coincidence rate (Total)
200 200 (100%) 200 (100%) 200 (100%)

 

Clinical Performance of positive sample (infection time 4-10 days)

Negative Cases (By PCR&CT) Negative coincidence rate (VivaDiagTM COVID-19 IgM) Negative coincidence rate (VivaDiagTM COVID-19 IgG) Negative coincidence rate (Total)
80 65 (81.25%) 30 (37.5%) 65 (81.25%)

 

Clinical Performance of positive sample (infection time 11-24 days)

Negative Cases (By PCR&CT) Negative coincidence rate (VivaDiagTM COVID-19 IgM) Negative coincidence rate (VivaDiagTM COVID-19 IgG) Negative coincidence rate (Total)
70 68 (97.1%) 67 (95.7%) 68 (97.1%)

 

Relative Specificity: 100%
Relative Sensitivity (infection time 4-10 days, IgM & IgG): 81.25%
Relative Sensitivity (infection time 11-24 days, IgM & IgG): 97.1%
Accuracy (infection time 4-10 days, IgM & IgG): 94.6%
Accuracy (infection time 11-24 days, IgM & IgG): 99.3%
Total accuracy: 95.1%

Google Rating
4.9
Based on 34 reviews

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