Lecurate IVD rapid test for detection of IgM/IgG antibodies to coronavirus

The kit is indicated for in vitro diagnostics (IVD) for qualitative detection of IgG and IgM antibodies of COVID19 infection in human serum, plasma, venous and capillary blood.

How to take, the dosage

Sample collection and preparation

TESTING PROCEDURE

Bring reagents and biological sample to room temperature before testing.

Extract a whole blood sample from a vein or finger, or a serum or plasma sample. Using the disposable pipette provided, draw 10 µl of serum/plasma sample (corresponding to the first black fill line on the pipette) or 20 µl of whole blood sample (corresponding to the second black fill line on the pipette) and transfer sample to well A on the test card, then add 2 drops of buffer solution to well B and start timing.

3 Wait for the colored line C to appear, indicating that the test was performed correctly. The results should appear within 5-10 minutes. Do not accept the result after 15 minutes.

Special Instructions

The alcohol wipe and lancet are not included.

QALITY CONTROL

The internal quality control process is included in the test. The colored line that appears in the control area (C) is an internal positive procedural control. It confirms sufficient sample volume and correct methodology.

SAFETY MEASURES

Potential risk of product use Class 2b

Features

Diagnostic sensitivity and specificity.

The clinical application was evaluated by the Beijing Aipuyi Medical Inspection Center for this product and compared with nucleic acid test (PCR) results. Diagnostic sensitivity was found to be 98.9%*, Diagnostic specificity was 97.6%**, indicating a high level of agreement with the reference product. However, in rare cases, the test may give false positive or false negative results.

*In clinical trials in Russia, diagnostic sensitivity: 100% (95% CI:96%-100%)

**In clinical trials in Russia, diagnostic specificity: 100% (95% CI:96%-100%).

Cross-reactivity.

. This test kit has no cross-reactivity with endemic human antibody other types of coronavirus, HBV, HCV, HIV-1, HIV-2, Adenovirus, Human Metapneumovirus (hMPV) , Parainfluenza virus 1-4, Influenza A, Influenza B, Enterovirus 71, Respiratory syncytial virus, Rhinovirus, Chlamydia pneumoniae, Streptococcus pneumoniae, Mycobacterium tuberculosis, Mycoplasma pneumoniae, EB Virus.

Interfering substances.

The test results are not affected by substances in the following concentrations: bilirubin concentration ≤60 mg/dL; triglyceride concentration ≤50 mg/dL; hemoglobin concentration ≤1000 mg/dL, rheumatoid factor ≤ 80 units/ml. Test results are not affected by: antinuclear antibody 81, HAMA.

Contraindications

Side effects

Assignments

The Leccuratetm kit for IVD rapid assay of antibodies to SARS-CoV2 IgG / IgM by immunochromatography. Batch No. 20CG2520X (hereinafter referred to as kit, test, product) is intended for in vitro diagnostics (IVD) for qualitative detection of IgG and IgM antibodies of COVID19 infection in human serum, plasma, venous and capillary blood.

The product is non-sterile, disposable.

The single test card is used for a single test to detect the presence of coronavirus antibodies in the professional diagnosis of COVID-19 in both symptomatic and asymptomatic patients.