2019-NCoV Whole Blood Neutralizing Antibody Rapid Test Kit With Detection Card

Sample Requirements

1. Collect serum, plasma or whole blood samples.
2. Precipitates and suspended matter in the sample affect the experimental results and must be removed by centrifugation.
3. Use of anticoagulants: jellyfish skin, EDTA, sodium citrate Anticoagulants have little effect.
4. Blood collection should be done by a medical professional. Priority is given to serum / plasma tests. In emergencies and special cases, a patient's whole blood sample can be used for rapid testing.
5. The storage time of serum and plasma samples at room temperature should not exceed 8 hours. 2 ° C-8 ° Can be stored at ° C for 6 months and 5 days, but do not overwhelm the freeze-thaw cycle. All blood samples should be frozen at 48 ° C to 8 ° C.

Test Method

Please read the instructions carefully before the test. Bring all reagents to room temperature before testing. The inspection is performed at room temperature.

1. Remove the test card from the packaged reagent bag and use it within 1 hour.
2. Test well loading Well μ add L (serum, plasma or whole blood) sample, μ add sample buffer and start timing.
3. The result will be invalidated after 20 minutes.

Interpretation of Test Results

Interpretation of test card
1. Invalid result: The quality control line (C line) is invalid. There is no reaction line and it will need to be retested.
2. Negative result: A red band appears on the test line (t line), and the color development performance is the standard line (r line), quality control line (C line), and reference line (r line).
3. Positive result: No red band appears on the test line (t line). The red band on the test line (t line) is color coded based on the reference line (r line) and quality control line (C line), and is color coded based on the reference line (r line).

Limitation of Test Method

This device is used only for in vitro diagnostics.
2. If there are too many or too small samples, the result will be false.
3. Hemolysis, blood fats, jaundice, and contaminated samples should be affected as they can affect test results.
4. Reagent test results are for clinical reference only and cannot be the sole basis for clinical diagnosis and treatment. The final diagnosis of this disease should be based on a comprehensive assessment of all clinical and laboratory results.

Product Performance Indicators

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1. Specificity analysis
1.1 cross reaction: the following types of antibody evaluation were conducted for interference with reagents, and no cross reaction occurred.

1.2 Interfering substances: The new coronavirus (2019 ncov) neutralizing antibody test item evaluates the potential interference of the following substances by adding the following substances to a sample of a specific concentration. As a result, it was clarified that each interfering substance did not interfere with the detection result of the reagent.

2.Clinical study: 120% positive and 300% negative samples selected from Novell Coronavirus (2019 nCoV) IgG detection reagent (colloidal gold method) as controls. The results can be summarized as follows.

Precautions