Leccurate SARS-CoV-2 Antibody Test

PRODUCT DESCRIPTION

The Leccurate SARS-CoV-2 Antibody Test can quickly show if a person developed antibodies following a Corona virus infection. It’s based on the principle of antigen-antibody reaction and immunoassay technique.

Additional Information

THIS PRODUCT CAN BE DELIVERED TO MEDICAL PROFESSIONALS ONLY; orders from consumers will be cancelled.

Prices shown are end-user prices for single package orders. Volume discounts available upon request.

PRODUCT FEATURES
  • Accurate: High-purity antibody with high accuracy

  • Efficient: Precise test results ready in 15 minutes

  • Convenient: Usable with blood obtained by finger prick

  • Application: For suspicious patients with symptoms, mild symptoms, or even without symptoms, also for testing people with close contact of infected patients and people under quarantine control.

PRODUCT SPECIFICATIONS

INSTRUCTIONS FOR USE:

 

  1. Add the sample to container A (20uL of whole blood, 10uL of plasma or serum)

  2. Add 2 drops (approx. 80uL) of the diluent to container B and set a timer for 15 minutes.

  3. The test results should be read within 10-20 minutes. Results are invalid after 20 minutes.

 

  • Type of Sample: whole blood / plasma / serum

  • Sample Volume: 20uL / 10uL / 10uL

  • Reaction Time: 15 minutes

  • Storage Conditions: 4-30 °C

 

 

INTERPRETATION OF RESULTS:

  • IgG POSITIVE: * Two coloured lines appear. A coloured line should always appear in the control line area (C) and another line should be in the IgG (G) line area.

  • IgM POSITIVE: * Two coloured lines are displayed. A coloured line should always appear in the control line area (C) and another line should be in the IgM (M) line area.

  • IgG e IgM POSITIVE: * Three coloured lines are displayed. A coloured line must always appear in the control line area (C) and two test lines must be in the IgG (G) line area and the IgM (M) line area.

 

 

* NOTE: the color intensity in the test line areas may vary based on the concentration of the 2019-nCoV antibodies present in the sample. Therefore, any shade of color in the area of ​​the test line should be considered positive.

 

  • Negative: A coloured line appears in the area of ​​the control line (C). No lines appear in the IgG (G) area and in the IgM (M) area.

  • Test Invalid: The control line (C) is not displayed. Insufficient sample volume or incorrect procedural techniques are the most likely reasons for the failure of the control line. Review the procedure and retest the test. If the problem persists, stop using the kit immediately.

  • Detection Limit of Sensitivity: For the detection of sensitivity reference material, the positive detection rate should be no less than 90%.

  • Negative Reference Products Compliance Rate: For the detection of negative reference material, the negative detection rate should be 100%.

  • Positive Reference Products Compliance Rate: For the detection of positive reference material, the positive detection rate should be 100%.

 

STORAGE AND STABILITY

  • It should be stored at 4°C~ 30°C, be kept dry and away from sunlight. The shelf life is 12 months.

  • For per test strip, it should be used within 1 hour after unsealing. Production Date and Expiration date are shown in the package label.

PACKAGING DETAILS
  • 20 Tests

  • 1 IFU (instruction for use)

  • 1 Lot number card

Antibody Rapid Test Kit

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