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

1. The COVID-19 IgG/IgM express test is intended for use only with human whole blood (capillary or venous), serum or plasma samples.
2. Only clear, unhemolyzed samples are recommended for use with this test. Serum or plasma should be separated as soon as possible to avoid hemolysis.
3. Test immediately after collecting samples. Do not leave samples at room temperature for extended periods of time. Serum samples can be stored at 2-8°C for up to 3 days. For long term storage, serum samples should be stored below -20°C and should not be refrozen once thawed.
4. Fresh samples to room temperature before testing. Frozen samples must be completely thawed and thoroughly mixed before testing. Avoid repetitive freezing or thawing of the samples.
5. If the samples must be shipped, package them according to all applicable regulations for shipment of etiological agents.
6. Icteric, lipemic, hemolyzed, heat treated and contaminated sera can lead to erroneous results.

TESTING PROCEDURE

Bring reagents and biological sample to room temperature before testing.

1. Remove the test card from the reagent package and use within 1 hour.
2. Place the test card on a clean and flat surface.

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

1. Do not use the test if the package is damaged.
2. Handle all samples as if they contained infectious agents. Follow established precautions against microbiological hazards throughout the test and follow standard procedures for proper specimen disposal.
3. Wear protective clothing: lab coats, disposable gloves and eye protection when taking and testing specimens.
4. The test can only be used once. The used test must be disposed of in accordance with the safety regulations established by the SanPin, other acts of the authorities of the Russian Federation.
5. Test is intended only for professional diagnosis by a physician or under the supervision of a doctor. The test results of this product should be evaluated comprehensively by your physician in conjunction with other clinical information and should not be used as the sole criterion.
6. Please read the instructions carefully before testing and follow the procedure correctly.
7. NOT TO CHECK.
8. Do not use after the expiration date, especially at temperatures above 30°C or in high humidity environments.

Potential risk of product use Class 2b

• Exclusively for in vitro diagnostic procedures.
• Exclusively for use by trained medical personnel.
• All steps must be performed in a consistent manner according to these instructions.
• Test results may be invalid if there is any deviation from those indicated in these instructions.
• Separate areas, specialized equipment (e.g., pipettes and microcentrifuges) and replacement materials (e.g., microcentrifuge tubes, pipette tips, gowns and gloves) should be available for reagent preparation and handling of extracted nucleic acids. Surfaces should be cleaned and decontaminated.
• Prepare pipettes in the accepted manner to obtain accurate results and do not reuse pipette tips.
• Prepare instruments by following the instructions for each instrument.

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

No.

Side effects

No.

Assignments

The Leccurate^tm 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.