Singclean Wholesale CE Approved Ivd Influenza a/B Antigen Rapid Medical Self Test for Home Testing Infection Disease (Colloidal Gold)

• Customization: Available
• Type: IVD Reagent
• Transport Package: Carton or OEM
• Model NO.: Singclean
• Trademark: Singclean
• Origin: China
• Production Capacity: 50000PCS/Day

Product Description

Product Introduction
Influenza viruses(Flu) are the pathogens that cause influenza. The seasonal flu epidemics are caused by two main types of influenza viruses, A and B. About 10% of the population is being affected every year.
The symptoms of influenza are similar to corona and other viral respiratory infections including fever, cough, stuffy nose, body aches, etc. Clinically it is hard to differentiate these from each other and the Singclean Flu A&B Antigen Test Kit can be used to screen for influenza, and help with the early diagnosis and treatment.

Intended Use

Singclean Flu A/B Antigen Test Kit is an in vitro qualitative detection that uses colloidal gold immunochromatography to test influenza A/B antigen in nasopharyngeal swab samples obtained from patients with signs and symptoms of respiratory infection in just 15 minutes. it is designed to give rapid and reliable test results on the spot without any laboratory equipment. This allows early start of treatment, which helps reduce the duration and severity of the disease. Besides, the detection of influenza reduces unnecessary use of antibiotics and aids in limiting the spread of the infection.

Specification
 

Singclean FLU A/B Antigen Test Kit
Sample type	Nasopharyngeal swab
Format	1 Test/Box;20 Tests/Box
Material s supplied	Sampling Cotton Swabs; Antigen Extraction Buffer; Antigen Extraction Tube; Paper Workbench; Instruction for Use
Time to results	15 minutes
Storage	Store between 4-30ºC
Shelf life	2 years

Advantages
 

a. Easy to operate: All components are included in the kit, and no additional equipment or laboratory resources are required;
b.Fast detection: 15 minutes to interpret the result after collecting the specimen;
c.Joint testing: Influenza A and B can both be tested in one reagent;
d. Accurate, Rapid, Sensitive
High-quality CE marked and approved for sale in Europe
 

Performance Characteristics
A total of 406 samples were tested in this study. The results of the test reagent and control reagent both were 215 negative specimens,92 Flu A positive specimens, and 99 Flu B positive specimens.
Test Procedure
Interpretation of Results

Positive:
Positive influenza A and B: Line C, Line A, and Line B all appeared. A positive result in the influenza A region and influenza B region indicates that both Influenza A and Be antigens were detected in the sample. 
lnfluenza A Positive:
Line C and Line A both appeared. A positive result in the Influenza A region indicates that Influenza A antigen was detected in the sample.
lnfluenza B Positive:
Line C and line B both appeared. A positive result in the Influenza B region indicates that influenza B antigen was detected in the sample.
Negative:
Only Line C appeared, with the absence of any burgundy color in the T band, the result indicates that no Flu A/B antigens are detected in the specimen.
Invalid:
The control line fails to appear.

Limitations
1. Use fresh samples whenever possible.
2. Optimal assay performance requires strict adherence to the assay procedure described in Instructions for use. Deviations may lead to aberrant results.
3. A negative result for an individual subject indicates the absence of detectable Flu AB antigen. However, a negative test result does not preclude the possibility of exposure to or infection with Flu A/B
4. A negative result can occur if the quantity of the Flu A/B antigen present in the specimen is below the detection limits of the assay, or if it fails to collect the Flu AB antigen in the nasal cavity of the patient.
5. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.