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ISO13485 96.6% Neutralizing Antibody Rapid Test Kit SARS-CoV-2

Categories Neutralizing Antibody Rapid Test
Brand Name: Aichek
Model Number: COVID-19-G02001A
Certification: CE
Place of Origin: China
MOQ: 5000 Test
Price: negotiable
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: SARS-CoV-2 ISO13485 Rapid Neutralizing Antibody Test Kit 96.6%
OEM: OEM customized packing avaliable
Formats: 25T/box 1T/box
Sample: Blood
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ISO13485 96.6% Neutralizing Antibody Rapid Test Kit SARS-CoV-2

SARS-CoV-2 ISO13485 Rapid Neutralizing Antibody Test Kit 96.6%


For professional and in vitro diagnostic use only.

Product NameSARS-CoV-2 ISO13485 Rapid Neutralizing Antibody Test Kit 96.6%
FormatsStrip(3mm)Device(4mm) uncut sheet
Place of OrigenChina
SpecimenBlood
Read Time15 minutes
Shelf life2 years
Package25T/Box
Storage2℃-30℃

For professional and in vitro diagnostic use only.


Product Feature

  • Fast Test, get antigen test result within 10-15 minutes.
  • High sensitivity and specificity
  • Easy to operate, no need equipment, convenient and fast
  • Require little Specimens

[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:

cPassTMTotal
PositiveNegative

Test

reagent

Positive96298
Negative9221230
Total105223328

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%).

[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.


Quality ISO13485 96.6% Neutralizing Antibody Rapid Test Kit SARS-CoV-2 for sale
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