Vstrip Flu A&B Rapid Test

Vstrip Flu A&B Rapid Test


Negotiable Min Order Quantity Unit

Required Quantity
Place of Origin
Taiwan
Brand name
Vstrip
Payment Terms
T/T
Production method
Negotiable
Shipping / Lead Time
Negotiable / Negotiable
Keyword
flu, in vitro diagnostic, rapid test, influenza a&b
Category
Medical Test Kit

Panion&BF Biotech Inc.

Membership
PRO
Country / Year Established
Taiwan Taiwan / 1976
Business type
Manufacturer
Verified Certificate

7

Product name Vstrip Flu A&B Rapid Test Certification -
Category Medical Test Kit Ingredients -
Keyword flu , in vitro diagnostic , rapid test , influenza a&b Unit Size -
Brand name Vstrip Unit Weigh -
origin Taiwan Stock -
Supply type - HS code -

Product Information

Vstrip Flu A&B Rapid Test

INTENDED USE

VstripÒ Flu A&B Rapid Test is a rapid in vitro immunochromatographic assay for the qualitative detection of influenza type A and type B virus from the nasopharyngeal swab of symptomatic patients.

 

FEATURES

Method: Monoclonal immunochromatographic assay

Specimen: Nasopharyngeal swab

Detection Device: Dipstick

Time to Result: 10 minutes

External Quality Control: Positive influenza A and

influenza B control swab

Package: 20 tests/kit

Storage temperature: 15-30℃

 
CLINICAL PERFORMANCE:     

Comparison study was conducted in 132 patients with Flu-like symptoms and compared the results of Vstrip Flu A&B Rapid Test to a FDA-cleared commercial kit.

               Type A    Type B
Sensitivity:    94.7 %    91.3 %
Specificity:   97.9 %    100 %
Accuracy:    97.0 %     98.5 %
PPV:          94.7 %     100 %
NPV:          97.9 %     98.2 %
 
ANALYTICAL SENSITIVITY

Among the 14 influenza A strains (H1N1, H3N2, etc) and 3 influenza B virus(Victoria, Yamagata), the minimum detectable concentration was: 

Flu A H1N1 subtype: 1.0   x 104 TCID50/ml

Flu A H3N2 subtype: 5.0   x 103 TCID50/ml

Flu B virus           : 1.25 x 105 TCID50/ml

 

ANALYTICAL SPECIFICITY

The cross reactivity study was evaluated with a total of 15 bacteria strains and 5 viruses strains. None of these tested microorganisms gave a positive result. 

 

CERTIFICATION
ISO 13485
CE Mark
TFDA


 

B2B Trade

Price (FOB) Negotiable transportation -
MOQ Negotiable Leadtime Negotiable
Payment Options T/T Shipping time Negotiable

Panion&BF Biotech Inc.

Country / Year Established
Taiwan Taiwan / 1976
Membership
PRO
Business type
Manufacturer

7

President
Zong-Ming Jiang
Address
1 F, No.308-8, Sec. 1, Datong Rd., Xizhi Dist., New Taipei City 22146 Taiwan
Product Category
Examination & Testing Instrument
Year Established
1976
No. of Total Employees
101-500
Company introduction

 

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