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 | Easy to carry IVD Neutralizing Antibody Rapid test For Travel |
| 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 | Easy to carry IVD Neutralizing Antibody Rapid test For Travel |
| 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 | Travel Neutralising Antibody Test Kit ，IVD Travel Neutralising Antibody Test ，25pcs Neutralizing Antibody Kit | ||
Easy to carry IVD Neutralizing Antibody Rapid test For Travel
For professional and in vitro diagnostic use only.
| Product Name | Easy to carry IVD Neutralizing Antibody Rapid test For Travel |
| 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%).
[TEST PROCEDURE]
Allow the test device and specimens to equilibrate to temperature (15-30℃or 59-86℉) prior to testing.
1. Remove the test device from the sealed pouch.
2. Hold the dropper vertically and transfer 1 drop of serum/plasma or 2 drops of whole blood to the sample well (S) of the test device. Make sure there are no bubbles. For better precision, we suggest transfer specimen by a pipette
3. Then add 2 drops of buffer and start the timer.
4. Wait for colored lines to appear. Interpret the test results after 15 minutes. Do not read results after 20 minutes.
[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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