SARS RBD Neutralization Antibody
Method: Latex
Immunoturbidimetric Method
Liquid reagent, R1:R2=3:1
CLINICAL SIGNIFICANCE
Novel Coronavirus (SARS
CoV-2) was discovered as a novel case of viral pneumonia in 2019, the clinical
manifestations are fever, fatigue and other systemic symptoms, accompanied by
dry cough, dyspnea, etc., which can rapidly develop into severe pneumonia, respiratory
failure, acute respiratory distress syndrome, toxic shock, multi-organ failure,
severe acid-base metabolism disorder, and even life-threatening. Novel
Coronavirus SARS CoV-2 belongs to the family of βcoronaviruses, is enveloped,
the particles are circular or elliptic, and are often pleomorphic with a
diameter of 60-140nm. Its genetic characteristics are obviously different from
SARSr-CoV and MERSr-CoV. Current studies have shown that the homology with bat
SARS-like coronavirus (BAT-SL-CovZC45) is over 85%.The coronavirus genome
encodes spike protein (S protein), envelope protein, membrane protein, and
nucleocapsid protein (N protein) in turn.S protein comprises an S1 subunit, and
an S2 subunit.
|
Vaccination |
Antibody result |
PCR result |
Explain of the result |
|
No |
- |
- |
Not infect by COVID-19 |
|
No |
- |
+ |
Infected by COVID-19 |
|
No |
+ |
- |
It is necessary to dynamically measure the antibody concentration, combined with clinical and other indicators. If the antibody concentration continues to rise, it may be asymptomatic infection |
|
No |
+ |
+ |
Infected by COVID-19 |
|
Yes |
- |
- |
Vaccination failed, Not infect by COVID-19, antibody seroconversion failed after injecting the vaccine |
|
Yes |
- |
+ |
Vaccination failed, infected by COVID-19 |
|
Yes |
+ |
- |
Vaccination succeed, Not infect by COVID-19, antibody seroconversion succeed after injecting the vaccine |
|
Yes |
+ |
+ |
Vaccination failed, infected by COVID-19 |
The receptor-binding domain (RBD) of S1 is immunodominant and accounts for 90% of serum neutralizing activity. And according to some articles and testing data, compared with S1 protein, S2 protein and S protein, RBD has the strongest reactivity with vaccine serum. RBD is a alternative detection tool for coronavirus infection diagnosis or the seroconversion rate of the antibody after vaccination.
LOW DETECTION LIMIT
The detection limit: ≤ 2.9BAU/ml
ACCURACY
|
|
Mean(BAU/ml) |
CV (%） |
|
Level1 |
6.3 |
3.33 |
|
Level 2 |
13.9 |
-2.83 |
2. Compare with competitors
2.1 The according rate of negative specimens is more than 95%(n≥20)
2.2 The according rate of positive specimens is more than 90%(n≥20)
PRECISION
|
|
Mean(BAU/ml) |
CV (%） |
|
Level1 |
6.1 |
6.16 |
|
Level 2 |
14.3 |
3.22 |
INTERFERENCES
Substances in the following concentration range have no more than 10% influence on the detection results: binding bilirubin ≤40mg/dL, hemoglobin ≤500mg/dL, Intralipid ≤200mg/dL, RF≤500IU/ mL.