Leccurate COVID-19 (Sars-CoV-2)

Product Information

This covid-19 serological test can quickly show if a person developed antibodies following a Corona virus infection. The Leccurate test for Covid-19 (Sars-CoV-2) is based on the principle of antigen-antibody reaction and immunoassay technique.
Kit containing 20 tests

*For Professional Use Only

Description

This test can quickly show if a person developed antibodies following a Corona virus infection with COVID-19.

The Leccurate test for Covid-19 (Sars-CoV-2) is based on the principle of antigen-antibody reaction and immunoassay technique.

Antibodies are produced after the invasion of the virus. Immunoglobulin M (IgM) comes first, acting on the first signs of infection. Immunoglobulin G (IgG) comes later, with a stronger and specific reaction to the virus.

• Accurate
• Efficient: only 15 minutes for the result.
• Convenient: usable with blood obtained by puncture on the finger.

Content:

• 20 tests.
• User manual.

Operating steps:

1) Add the sample to container A (20ul of whole blood, 10ul of plasma or serum.
2) Add 2 drops (about 80ul) of diluent to container B.
3) Read the results after 10/20 minutes from point 2. The results read after 20 minutes are not considered valid.

• 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 colored lines appear. A colored line should always appear in the control line area (C) and another line should be in the IgG (G) line area.

IgM POSITIVE: * two colored lines are displayed. A colored 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 colored lines are displayed. A colored 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 colored 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%.

Lepu Medical COVID-19 Antibody Test – Material Safety Data Sheet (MSDS)

Lepu Medical COVID-19 Antibody Test – Declaration of Conformity

N.B. The kit does not include lancing devices.

For professional use only. For professional operators only.

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