Hangzhou Aichek Medical Technology Co.,Ltd
| Payment Terms | T/T |
| Supply Ability | negotiable |
| Packaging Details | 40box/carton |
| Storage | 2℃-30℃ |
| User | Everyone |
| Accuracy | 99.05% (95% CI: 97.58%~99.63%) |
| Certificate | CE ISO 13485 |
| Key words | uncut sheet for 2019-nCov neutralizing Antibody test Competition Method |
| OEM | OEM customized packing avaliable |
| Formats | 25T/box 1T/box |
| Sample | Blood |
| Brand Name | Aichek |
| Model Number | COVID-19-G02001A |
| Certification | CE |
| Place of Origin | China |
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Product Specification
| Payment Terms | T/T | Supply Ability | negotiable |
| Packaging Details | 40box/carton | Storage | 2℃-30℃ |
| User | Everyone | Accuracy | 99.05% (95% CI: 97.58%~99.63%) |
| Certificate | CE ISO 13485 | Key words | uncut sheet for 2019-nCov neutralizing Antibody test Competition Method |
| OEM | OEM customized packing avaliable | Formats | 25T/box 1T/box |
| Sample | Blood | Brand Name | Aichek |
| Model Number | COVID-19-G02001A | Certification | CE |
| Place of Origin | China | ||
| High Light | Neutralizing Antibody Test Uncut Sheet ，Competition Test Uncut Sheet ，2019-NCov Uncut Sheet | ||
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%).
| 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 | / |
| uncut sheet |
Company Details
Business Type:
Manufacturer
Year Established:
2012
Total Annual:
500000-1000000
Employee Number:
150~200
Ecer Certification：
Active Member
Hangzhou Aichek Medical Technology Co.,Ltd Hangzhou Aichek Medical Technology Co.,Ltd is a high-tech company specialises in manufacturing rapid diagnostic and healthcare products. With five product lines of fertility, infectious diseases, cardiac marker, tumor marker and drug of... Hangzhou Aichek Medical Technology Co.,Ltd Hangzhou Aichek Medical Technology Co.,Ltd is a high-tech company specialises in manufacturing rapid diagnostic and healthcare products. With five product lines of fertility, infectious diseases, cardiac marker, tumor marker and drug of...
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