CE Coronavirus Neutralizing Antibody Rapid Test Detection Card Sample Buffer

2 ℃ ~30 ℃ Save, valid for 12 months.
Effective for 1h. after removing the aluminum foil bag
Product lot number: see the label for details.
Product failure date: see the label for details.

Sample Requirements

1. collected serum, plasma, or whole blood samples.
The sediment and suspended objects in the 2. samples may affect the experimental results and should be centrifuged.
3. Anticoagulant: No significant effect on using heparin, EDTA, and sodium citrate anticoagulant.
4. blood collection should be carried out by professional medical staff with preferred serum / plasma testing and whole blood samples available for rapid testing in emergency or special situations.
5. serum and plasma samples can be stored at room temperature beyond 8h,2 ℃ ~8 ℃ for 5 days, and under-20 ℃ for 6 months but to avoid repeated freezing and thawing. Whole blood samples shall not be frozen and shall not exceed 48 h. under 2 ℃ ~8 ℃

Test Method

1.Invalid result: quality control line (C line) no reaction line, invalid detection, should be retested.
2. negative results: red band appears in test line (line T), and color show above or equal to control line (R line), mass control line (line C line) and control line (line R) show color.
3. positive results: no red band in test line (T line) or red band in test line (T line), but the color display was lower than control line (R line), mass control line (C line) and control line (R line).

Interpretation of Test Results

1.This kit is qualitative detection and is only used for in vitro assisted diagnosis.
2. Make sure a proper sample is added for testing. Too much or too small a sample size can cause inaccurate results.
3. hemolysis, hyperlipidemia, jaundice and contaminated samples may affect the test results and these samples should be avoided.
4. The test results of this reagent are only for clinical reference only and shall not be used as the sole basis for clinical diagnosis and treatment. The final disease diagnosis should be made after comprehensive evaluation of all clinical and laboratory results.

Limitation of Test Method

1. This kit is for qualitative detection and is only used for in vitro auxiliary diagnosis.
2. Make sure you add the right amount of samples for testing. Too many or too few samples may result in inaccurate results.
3. Hemolysis, lipidemia, jaundice and contaminated samples may affect test results and should be avoided.
4. The test results of this reagent are only for clinical reference and should not be used as the sole basis for clinical diagnosis and treatment. The final diagnosis of the disease should be made after a comprehensive evaluation of all clinical and laboratory results.

Product Performance Indicators

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1. Analysis of specificity
1.1 Cross-reaction: The following types of antibodies were assessed with reagents and the results showed no cross-reaction.

1.2 Interference substances: The following concentrations were added in the specified concentration sample to assess their potential interference in the novel coronavirus (2019-nCoV) and in the antibody test program. The results showed that the various interfering substances do not disturb the test results of the reagent.

2. 2. clinical study: Listed Novel Coronavirus (2019-nCoV) IgG antibody detection reagent (colloidal gold method) was used as the comparative reagent, and 120 positive samples and 300 negative samples were selected respectively. The results were summarized as follows:

Precautions