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 | Cov-19 nab neutralizing Antibody Rapid Test Kit blood test |
| 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 |
View Detail Information
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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 | Cov-19 nab neutralizing Antibody Rapid Test Kit blood test |
| 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 | Nab Rtk Blood Test ，Nab Rtk Neutralizing Antibody Rapid Test Kit ，Cov-19 Nab Rtk Blood Test | ||
Cov-19 nab neutralizing Antibody Rapid Test Kit blood test
For professional and in vitro diagnostic use only.
| Product Name | Cov-19 nab neutralizing Antibody Rapid Test Kit blood test |
| Formats | Strip(3mm)Device(4mm) uncut sheet |
| Place of Origen | China |
| Specimen | Blood |
| Read Time | 15 minutes |
| Shelf life | 2 years |
| Package | 25T/Box |
| 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%).
[COMPOSITION]
The device is mainly composed of a nitrocellulose (NC) membrane strip assembled into a cassette. On the NC membrane, the T line is coated with ACE2, and the C line is goat anti mouse IgG polyclonal antibody. Dye conjugated with SP is embedded in the reagent pad.
The quantity of tests was printed on the labeling.
Materials Provided
·Test cassette ·Buffer ·Dropper · Package insert · Desiccant
Materials Required But Not Provided
·Timer
[STORAGE AND STABILITY]
Store as packaged in the hermetic bag at the temperature (2-30℃ or 38-86℉) and avoid direct sunshine. The kit is stable within the expiration date printed on the labeling.
Once open the hermetic bag, the test should be used within one hour. Prolonged exposure to hot and humid environment will cause product deterioration.
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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