New Coronavirus Neutralizing Antibody Rapid Test For Serum Plasma

Sample Requirements

1 serum, plasma or whole blood samples.
Since precipitates and floatings in the sample may affect the experimental results, centrifugation must be removed.
Anticoagulants using anticoagulant heparin, EDTA and sodium citrate were not effective.
4. It is recommended that a professional medical staff should do so and prioritize serum / plasma examination. In case of an emergency or a special case, the patient's whole blood sample can also be used for quick inspection.
5.Serum and plasma samples can not exceed 8h at room temperature, can be stored at 5 to 8 degrees Celsius for 5 days, and can be kept at - 20 degrees Celsius for 6 months to avoid repeated freezing and thawing. The whole blood sample should not be frozen, and should not be stored above 48 h at 2 to 8 ° C.

Test Method

Please read the usage instructions before the test. Return all reagents to room temperature before the test. Test should be done at room temperature.
1. Take out the test card from the packed reagent bag and use it within 1 hour.
2.Sample (serum, plasma or whole blood) 20 μ 2 drops of sample buffer solution μ L).
3. Reading after 20 minutes is invalid.

Interpretation of Test Results

Explanation of the test card

1.An invalid result: the quality control line (C line) reaction line appears, the detection is invalid, and the retest should be done.
2.Negative result: the red band appears in the inspection line (t line), and the color is higher than the control line (r line), and the quality control line (C line) and the control line (r line) color.
3.Positive result: the red band does not appear in the inspection line (t line), and the red band appears in the inspection line (t line), but the color is lower than the control line (r line), and the quality control line (C line) and the control line (r line) color.

Limitation of Test Method

1.This kit is a qualitative test and is used only for in vitro diagnosis.
2. If the number of samples is too small or too small, the result may be inaccurate.
3. Hemolysis, lipidemia, jaundice, contamination samples should be avoided because it may affect the test results.
4. The results of this reagent are only provided for clinical reference and should not be the only basis for clinical practice, and the final diagnosis should be performed after overall evaluation of all clinical and laboratory results.

Product Performance Indicators

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1. Specificity analysis

1.1Cross reaction: no interference was observed when the interference was tested for the following types of antibodies.

1.2 In order to evaluate the possibility of interferers, the following concentrations were added to the specified concentration samples. As a result, it was shown that various interferences did not interfere with the detection result of this reagent.

2.Clinical study: a novel test of the normal coronavirus (2019-ncov) IgG antibody test reagent (colloidal gold method) was carried out as a comparative reagent, and 120 positive and 300 samples were tested

Precautions