Accu-Tell® COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/ Serum/ Plasma)

Accu-Tell® COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/ Serum/ Plasma)

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 to SARS-CoV-2 in human whole blood, serum, or plasma as an aid in the diagnosis of primary and secondary COVID-19 infections.

CATALOG

KEY POINTS

Detection for: Qualitative detection of IgG and IgM antibodies to 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: At 10 minutes

Diagnostic Sensitivity: IgG: 100%; IgM: 91.8 %;

Diagnostic Specificity: IgG: 99.5%; IgM: 99.2 %;

Accuracy: IgG: 99.6 %; IgM: 97.8 %.

INTRODUCTION

COVID-19(Corona Virus Disease) is the infectious disease caused by the most recently discovered coronavirus. This new virus and disease were unknown before the outbreak began in Wuhan, China, in December 2019. The most common symptoms of COVID-19 are fever, tiredness, and dry cough. Some patients may have aches and pains, nasal congestion, runny nose, sore throat or diarrhea. These symptoms are usually mild and begin gradually. Some people become infected but don’t develop any symptoms and don't feel unwell. Most people (about 80%) recover from the disease without needing special treatment. Around 1 out of every 6 people who gets COVID-19 becomes seriously ill and develops difficulty breathing. Older people, and those with underlying medical problems like high blood pressure, heart problems or diabetes, are more likely to develop serious illness. People with fever, cough and difficulty breathing should seek medical attention. People can catch COVID-19 from others who have the virus. The disease can spread from person to person through small droplets from the nose or mouth which are spread when a person with COVID-19 coughs or exhales. Most estimates of the incubation period for COVID-19 range from 1- 14 days.

INTENDED 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 to SARS-CoV-2 in human whole blood, serum, or plasma as an aid in the diagnosis of primary and secondary COVID-19 infections.

Allow the test cassette, 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 cassette from the sealed pouch and use it within one hour.

2. Place the test cassette on a clean and level surface. ·

  For Serum or Plasma or Whole Blood Specimens:

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

Ø To use a micropipette: Pipette and dispense 10μl of specimen to the specimen well (S) of the test cassette, 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 at 10 minutes. Do not interpret the result after 20 minutes.

EXPECTED VALUES

Primary COVID-19 infection is characterized by the presence of detectable IgM antibodies 3-7 days after the onset of infection. Secondary COVID-19 infection is characterized by the elevation of COVID-19-specific IgG. In the majority of the cases, this is accompanied by elevated levels of IgM.

PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

ACCU-TELL® COVID-19 IgG/IgM Cassette (Whole Blood/Serum/Plasma) was compared with a leading commercial PCR. The study included 181 specimens for IgG and IgM.

IgG Results

Diagnostic Sensitivity: 100% (95%CI: 86.2%~99.9%)*

Diagnostic Specificity: 99.5% (95%CI: 96.2%~99.9%)*

Accuracy: 99.6 %( 95%CI: 96.1%~99.9%)*

*Confidence Interval

IgM Results

Diagnostic Sensitivity: 91.8 %( 95%CI: 71.9%-95.6%)*

Diagnostic Specificity: 99.2 %( 95%CI: 95.0%~99.8%)*

Accuracy: 97.8 %( 95%CI: 92.2%~98.4%)*

*Confidence interval

Cross-reactivity

ACCU-TELL® COVID-19 IgG/IgM Cassette (Whole Blood/Serum/Plasma) has been tested for anti-influenza A virus, anti-influenza B virus, anti-RSV, anti-Adenovirus, HBsAg, anti-Syphilis, anti-H. Pylori, anti-HIV, anti-HCV and HAMA positive specimens. The results showed no cross-reactivity. Some cross reactivity was observed with samples positive for SARS-CoV antibody and Rheumatoid Factor. It is possible to cross-react with samples positive for MERS-CoV antibody.

Interfering  Substances

The following potentially interfering substances were added to SARS-CoV-2 negative and positive specimens.

Acetaminophen:  20 mg/dL             Caffeine: 20 mg/dL                   Albumin: 2 g/dL

Acetylsalicylic Acid:  20 mg/dL        Gentisic Acid: 20 mg/dL           Ethanol: 1%

Ascorbic Acid:  2g/dL                      Creatine: 200mg/dl                   Bilirubin: 1g/dL

Hemoglobin: 1000mg/dl                  Oxalic Acid: 60mg/dL                Uric acid: 20mg/ml

None of the substances at the concentration tested interfered in the assay.

LIMITATIONS

1. ACCU-TELL® COVID-19 IgG/IgM Cassette (Whole Blood/ Serum/Plasma) is for in vitro diagnostic use only. The test should be used for the detection of COVID-19 antibodies in whole blood, serum or plasma specimens only. Neither the quantitative value nor the rate of increase in COVID-19 antibody concentration can be determined by this qualitative test.

2. ACCU-TELL® COVID-19 IgG/IgM Cassette (Whole Blood/ Serum/Plasma) will only indicate the presence of COVID-19 antibodies in the specimen and should not be used as the sole criteria for the diagnosis of COVID-19.

3. In the early onset of fever, anti-COVID-19 IgM concentrations may be below detectable levels.

4. The continued presence or absence of antibodies cannot be used to determine the success or failure of therapy.

5. Results from immunosuppressed patients should be interpreted with caution.

6. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.

7. If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at any time preclude the possibility of COVID-19 infection.

Note: The above information is for reference use only. Please refer to the product insert provided with the products before use.