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SG Diagnostics

SG Diagnostics SAR-Cov-2 Neutralising Antibody Assay (CLIA)

SG Diagnostics SARS-CoV-2 Neutralizing Antibody Assay (CLIA) is the FIRST EVER Neutralising antibody that can be analysed automatically. It is an in vitro assay for the qualitative detection of SARS-CoV-2 Neutralizing Antibodies to the receptor binding domain (RBD) in human serum or plasma. It is intended to give an indication of the immunity strength of an individual after vaccination or past COVID-19 infection.

Antibody test can be distinguished into two kinds –the 1stkind consists of direct binding assay (e.g. lateral flow assay (LFA) rapid test), which detects total binding antibodies whereas the 2ndkind consists of competitive binding assay(e.g. conventional virus neutralization test (cVNT), pseudovirus-based VNT (pVNT), surrogate VNT (sVNT)), which detects neutralising antibodies. 

Neutralising antibodies are antibodies that bind to cell-free virus and prevent it from infecting cells. On the contrary, non-neutralizing antibodies are unable to prevent infection. Thus, competitive binding assay is more beneficial in indicate immunity against COVID-19 compared to direct binding assay

Chemiluminescence Immunoassay is a method to determine the concentration of a sample according to the intensity of the luminescence that a chemical reaction emits. It can be used to estimate analytes, including hormones, serological markers and drugs, that are present in the blood at low concentration.

  1. CLIA that uses Competitive Binding Assay:
  •  Antibody test can be distinguished into two kinds –the 1stkind consists of direct binding assay (e.g. lateral flow assay (LFA) rapid test), which detects total binding antibodies whereas the 2ndkind consists of competitive binding assay(e.g. conventional virus neutralization test (cVNT), pseudovirus-based VNT (pVNT), surrogate VNT (sVNT)), which detects neutralising antibodies.
  • Neutralising antibodies are antibodies that bind to cell-free virus and prevent it from infecting cells. On the contrary, non-neutralizing antibodies are unable to prevent infection. Thus, competitive binding assay is more beneficial in indicate immunity against COVID-19 compared to direct binding assay

2) Automatic Analyzer:

Eventhough ELISA test method is Competitive Binding Assay, is it a manual process. However, CLIA is automatic and has walk-away system, freeing up time for staff members.

Firstly, collect blood by venipuncture into appropriate blood collection tube. Secondly, test the sample in the analyser.

Step 1: Power on and login

Step 2: Consumable status check

Step 3: Reagent load

Step 4: Calibration request and test

Step 5: Quality control request and test

Step 6: The analyser will automatically calculate from the calibration curve to quantify the amount of SARS-CoV-2 neutralizing antibodies in the sample.

Machine will give a numerical output. If the output is greater than 0.3, Neutralising antibodies are saif to be found in the sample.

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Test Kit Specifications

Kit Content
nCoVNAbR1, nCoVNAbM, nCoVNAbCalibrator 1, nCoVNAbCalibrator 2, nCoVNAbLow value control, nCoVNAbHigh value control, nCoVNAbMaster curve and test definition
Specification
50 tests/kit, 100 tests/kit

Test Kit Characteristics

Assay format
Chemiluminescence Immunoassay
Machine
Chemiluminescence Immunoassay Analyzer (SMG0020)
Time to First Result
30 mins
Specificity
-
Sensitivity
-
Type of analyte
Neutralizing Antibody
Sample material
Serum, EDTA and heparin plasma, and plasma treated with separation gel

External Clinical Evaluation

Coming Soon

 

Instruction For Use is Coming Soon