uncut sheet for 2019-nCov neutralizing Antibody test Competition
Method
Product Name | uncut sheet for 2019-nCov neutralizing Antibody testCompetition
Method |
Formats | Strip(3mm)Device(4mm) uncut sheet |
Place of Origen | China |
Specimen | Blood |
Read Time | 15 minutes |
Shelf life | 2 years |
Package | uncut sheet |
Storage | 2℃-30℃ |
For professional and in vitro diagnostic use only.
[INTENDED USE]
The product is suitable for qualitative detection of neutralizing
antibodies (NAbs) against SARS-CoV-2 that block the interaction
between the receptor binding domain (RBD) of the spike glycoprotein
and the Angiotensin converting enzyme Ⅱ (ACE2) receptor. The device
can be instrumental in vaccine and therapeutic development as it is
suitable for all antibody isotypes. It may also help in current
COVID-19 investigations of sero-prevalence, assessment of human
immunity, longevity of protective immunity, efficacy of different
vaccine candidates as well as tracking infection.
[PERFORMANCE CHARACTERISTICS]
Sensitivity
The sensitivity to S-mIgG1 neutralizing antibody can reach 2ug/mL.
Accuracy
A side-by-side comparison was conducted by the results of
SARS-Cov-2 Neutralizing Antibody Test Device (Test Reagent)
developed by Hangzhou Deangel Biological Engineering Co., Ltd. and
cPassTM from Genscript CO., Ltd. 328 clinical specimens from Professional
Point of Care site were evaluated, 105 were positive and others
negative. Base on the results from the clinical studies, the
statistical analysis was made as follows:
| cPassTM | Total |
Positive | Negative |
Test reagent | Positive | 96 | 2 | 98 |
Negative | 9 | 221 | 230 |
Total | 105 | 223 | 328 |
For test reagent, the clinical sensitivity with the “Compared
Reagent” was 91.4% (95% CI: 77.7%~100%), the clinical specificity
was 99.1% (95% CI: 97.2%~100%), the coincidence rate was 96.6% (95%
CI: 92.4%~100%).
Uncut Sheet for SARS-CoV-2 Diagnosis
| Product | LOT NO | Size | Sample Type | LOD |
| Uncut Sheet for SARS-CoV-2 Antigen (Colloidal Gold) | SC2N802 | 6cm*30cm | Saliva | 50-100 TCID50/mL |
| SC2N804 | 6cm*30cm | Swab | 50-100 TCID50/mL |
| Uncut Sheet for SARS-CoV-2 Antigen (Latex) | SC2N814 | 6cm*30cm | Saliva | 40 TCID50/mL |
| SC2N813 | 6cm*30cm | Swab | 20 TCID50/mL |
| Uncut Sheet for SARS-CoV-2 nAb (Competition Method) | SC2NAb801 | 6cm*30cm | S/P/WB | 200ng/mL |
| Uncut Sheet for SARS-CoV-2 nAb (Sandwich Method) | SC2NAb801 | 6cm*30cm | S/P/WB | 150 ng/mL |
| Uncut Sheet for SARS-CoV-2 IgG/IgM | SC2GMAb801 | 6cm*30cm | S/P/WB | / |
