Hangzhou Aichek Medical Technology Co.,Ltd
| Payment Terms | T/T |
| Supply Ability | negotiable |
| Packaging Details | 40box/carton |
| Storage | 2℃-30℃ |
| User | Everyone |
| Accuracy | 96.6% (95% CI: 92.4%~100%). |
| Certificate | CE ISO 13485 |
| Key words | One Step Ncov-19 Neutralizing Antibody Test Kits For Vaccination Evaluation |
| 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 | 96.6% (95% CI: 92.4%~100%). |
| Certificate | CE ISO 13485 | Key words | One Step Ncov-19 Neutralizing Antibody Test Kits For Vaccination Evaluation |
| 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 | Ncov-19 Neutralization Antibody Detection Kit ，One Step Neutralization Antibody Detection Kit ，One Step neutralizing antibody kit | ||
One Step Ncov-19 Neutralizing Antibody Test Kits For Vaccination Evaluation
For professional and in vitro diagnostic use only.
| Product Name | SARS-CoV-2 ISO13485 Rapid Neutralizing Antibody Test Kit 96.6% |
| 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.
[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%).
[LIMITATIONS]
The device is limited to provide a qualitative detection. The intensity of the test line does not necessarily correlate to the concentration of the antibody in the blood.
Each physician must interpret the results in conjunction with the patient’s history, physical findings, and other diagnostic procedures.
If symptoms persist and the result from the device is negative, it is recommended to collect a new sample from the patient a few days later and test it again.
A negative result can occur if the titer of antibodies against the SARS-CoV-2 virus present in the specimen is below the sensitivity of the assay.
Improper sample collection, improper sample storage or repeated freezing and thawing of samples can lead to inaccurate results.
[SUMMARY]
The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.
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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