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Accu-Tell COVID-19 Serological Tests

A rapid test for the qualitative detection of antibodies (IgG and IgM) to SARS-CoV-2 (Covid-19) in whole blood, serum or plasma. With a single drop of blood, you get quick (10 minutes) and reliable data on the Covid-19 infection (positive or negative) and the individual’s antibody/immunity level.

 

DECLARATION
The Accu-Tell® COVID-19 IgG/IgM Rapid Test is for professional use. It is NOT for self-testing or home use;

 

CARACTERISTICS
Sample: Whole Blood/Serum/Plasma
Quantity per box: 50 tests
Certified: CE

 

Key points
Detection for: Qualitative detection of IgG and IgM antibodies against SARS-CoV-2 in human whole blood, serum or plasma as an aid in the diagnosis of primary and secondary COVID-19 infections.
Reading time: Within 10 minutes
Positive agreement: 93.5%;
Negative agreement: 97.5%;
Full agreement: 95.5%.

 

DESTINED USE
ACCU-TELL® COVID-19 IgG/IgM Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies against SARS-CoV-2 in human whole blood, serum or plasma as an aid in the diagnosis of primary and secondary COVID-19 infections.

 

TEST PROCEDURE

Allow the test cassette, sample, buffer and/or controls to reach room temperature (15-30°C) before testing.
1. The package must be at room temperature before opening. Remove the test cassette from the sealed package and use it within one hour.
2. Place the test cassette on a clean, level surface.

To use a dropper: Hold the dropper vertically, draw the specimen up to the Fill Line (approximately 10μl) and transfer the specimen to the sample well (S) of the test strip, then add 2 drops of buffer (approximately 80μl) to the buffer well (B) and start the timer. Avoid trapping air bubbles in the sample well.

To use a micropipette (recommended): Pipette and dispense 10μl of sample into the sample well (S) of the test strip, then add 2 drops of buffer (approximately 80μl) to the buffer well (B) and start the timer.
3. Wait for the colored line(s) to appear. The test result should be read within 10 minutes. Do not interpret the result after 20 minutes.

 

STORAGE AND STABILITY
The kit can be stored at room temperature or refrigerated (2-30°C). The test cassette is stable until the expiration date printed on its packaging. The test cassette should remain in the sealed package until use. Do not freeze. Do not use beyond the expiration date.

 

PERFORMANCE CHARACTERISTICS

Positive Result
The positive concordance of the ACCU-TELL® COVID-19 IgG/IgM Cassette (Whole Blood/Serum/Plasma) was evaluated using clinical samples collected from symptomatic individuals. All individuals were confirmed positive for COVID-19 by Nucleic Acid Test (RT-PCR) or clinical diagnosis.

Negative Result
The negative concordance of the ACCU-TELL® COVID-19 IgG/IgM Cassette (Whole Blood/Serum/Plasma) was evaluated using clinical samples collected from symptomatic individuals. Samples were collected during the 2020 COVID-19 pandemic and all were excluded for COVID-19 by Nucleic Acid Test (RT-PCR) or clinical diagnosis.
The positive and/or negative population was composed of the following subjects.
The results show that the positive concordance of the ACCU-TELL® COVID-19 IgG/IgM Cassette (Whole Blood/Serum/Plasma) is 93.5%, the negative concordance is 97.5% and the overall concordance is 95.5%.

 

INSTRUCTION VIDEOS:

  • Components of the Accu-Tell Covid Rapid Test Kit:

 

  • Accu-Tell Covid rapid test procedures:

 

  • Results of the Accu-Tell Covid rapid test: