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MicrofluidicsCoronavirus Test KitCOVID-19 Neutralizing Antibody Microfluidic Chip

SKU: IVD testing kits 12, COVID-19 Neutralizing Antibody Microfluidic Chip

Product Name: Rapid COVID-19 Neutralizing Antibody Test Kit, SARS-CoV-2 Neutralizing Antibody Test Kit,  Microfluidic device for COVID-19 Neutralizing Antibody

Sample type:Serum/Plasma

Detection type:Qualitative

Method: Microfluidic

Function: Diagnose

Certificate: ISO9001/ ISO13485/CE

Reading time: 6 minutes

Applications :

  • To evaluate the effectiveness of the SARS-CoV-2 vaccine in individuals
  • Screening of repurposed drugs for COVID-19
  • Establishment of dynamic monitoring mechanism of herd immunity
  •  Assistance in epidemiological investigation

Packaging Details:

Pouch+Box+Carton packaging

(1) With our company’s Logo

(2) With the natural package

(3) With OEM package

(4) ODM

Description

1. Product Description:

The presence of Neutralizing Antibody (NAb) could be used to evaluate immunity status after COVID-19 infection or vaccination. COVID-19 Neutralizing Antibody Microfluidic Chip is suitable for large-scale preliminary screening tests. It is an ideal alternative to the Microneutralization Assay for prompt and accurate test result interpretation.

COVID-19 Neutralizing Antibody Microfluidic Chip

2. Features :

  • More Rapid: Easy operation and Observed within 6 MIN, Continuous operations & simultaneous reactions outside the analyzer
  • Convenient: Maximum 15 days room temperature transportation, DO NOT require P3 lab or utilize live COVID-19 virus

 

3. Advantages:

I.   More Rapid : 

*  Easy operation

*   Observed within 6 MIN

*   Continuous operations & simultaneous reaction outside the analyzer

II.  More Accurate :

*   Sensitivity : 100%

*   Specificity : 97.56%

*   Total accuracy : 99.31%

III.  Convenient :

*   Analyzer: light & handy, portable, flexible working environment

*   Test cartridge:  Maximum 15 Days room temperature transportation

*   More secure:   DO NOT require P3 lab or utilize live COVID-19 virus

 

4. Principle:

This kit uses microfluidic technology, fluorescence technology, and an indirect competition method of comprehensive detection technology to detect SARS-CoV-2 neutralizing antibodies in human serum and plasma. Microfluidic technology is a detection technology that uses the microchannel inside the reagent cartridge to realize liquid quantification and uniform flow. During the detection, the SARS-CoV-2 neutralizing antibodies in the sample first react with the colloidal gold-labeled SARS-CoV-2 S-RBD proteins and then binds to fluorescent markers in the microchannel to form antibody-antigen immune complexes, the immune complexes depend on siphon action to flow forward automatically in the microchannel.

When flow to the detection area, the complex will not combine with ACE2 proteins coated in the detection area. When the sample does not contain SARS-CoV-2 neutralizing antibodies, the colloidal gold-labeled SARS-CoV-2 S-RBD proteins bind to fluorescent markers in the microchannel will combine with ACE2 proteins and be captured in the detection area. The unbound fluorescent markers will be captured in the quality control area, the residuum eventually flows to the waste area. On the NewScen Fluorimetric Immunoassay Analyser, it collects the fluorescence signal that excited by the excitation light in the detection area and the quality control area, the intensity of the fluorescence signal is negatively correlated with the level of SARS-CoV-2 neutralizing antibodies.

 

5. Sample Pretreatment:

COVID-19 NAb Test Kit

5.1. Open the sample collection tube, unscrew the cap of the diluent buffer tube, and then add 2 drops of diluent buffer to the sample collection tube;

5.2. Add 20μL serum or plasma sample into the sample collection tube;

5.3. Cover the pointed nozzle cap tightly, hold the outer wall of the sample collection tube, and shake the bottom of the tube tilted downward to ensure that the sample is fully mixed;

5.4. Reaction for 2 minutes.

 

6.Operation Procedure of COVID-19 Neutralizing Antibody Microfluidic Chip: https://youtu.be/chF5yOUejDk

Operation Procedure of COVID-19 Neutralizing Antibody Microfluidic Chip

6.1. The reagent should be tested at room temperature and the relative humidity is not higher than 90%.

6.2. All clinical samples must be at room temperature before beginning the assay.

6.3. Follow the instruction and installation guide of NewScen Fluorimetric Immunoassay Analyser. Import the code chip of the kit into the instrument.

6.4. Open the package, the pouch should be sealed well. If the test reagent store in the refrigerator, it should be restored at room temperature for 15~30 minutes. Then open the pouch and take out the test cartridge, place it on the platform.

6.5. Add 1 drop of the diluted sample to the sample drop, start timing. Insert test cartridge in the direction of the black arrow to the instrument after 4 minutes. The result is invalid after more than 20 minutes.

6.6. Calibration procedure: Before reading the reagent, confirm the instrument is in the normal operation state, and be calibrated by the instrument calibration card.

 

7. Result Interpretation:

The test result is represented by inhibition ratio (%),the formula is: Inhibition=(1-S/CO)×100%, “S” represents the signal value ratio of the test sample, and “CO” represents the cut off value of neutralizing antibody.

7.1. Positive SARS-CoV-2 neutralizing antibodies: the test results in≥30%.

7.2. Negative SARS-CoV-2 neutralizing antibodies: the test results in<30%.

 

Remark :

The test result is represented by inhibition ratio ( % ) = ( 1 – S/CO ) × 100%

S  =  Signal value ratio of the test sample

CO =  Cut-off value of neutralizing antibody

 

8. CE Qualified:

newscen

9. How many neutralizing antibodies are necessary to prevent coronavirus? (Answer by nature medicine)

Please see the Resources section from nature medicine:

https://www.nature.com/articles/s41591-021-01377-8