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Influenza A+B Rapid Test Uncut Sheet Nasopharyngeal Swab Rtk

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Hangzhou Aichek Medical Technology Co.,Ltd

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Influenza A+B Rapid Test Uncut Sheet Nasopharyngeal Swab Rtk

Name: Influenza AB Rapid Test Uncut Sheet Nasopharyngeal Swab Rtk
Brand: Aichek
Price: 1 USD

Brand Name : Aichek

Model Number : CHL-A01

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℃

Sample Type : Swab

User : Professional

Accuracy : 99.6% (97.7%-99.9%)

Certificate : CE ISO 13485

OEM : OEM customized packing avaliable

Formats : 25T/box 1T/box

After-sales Service : Available

Key words : Influenza A+B Antigen Rapid Test uncut sheet

For the crowd : Preliminary screening of infected people

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Infection Disease Influenza A+B Antigen Rapid Test with CE certificate uncut sheet

Product Name	Influenza A+B Antigen Rapid Test uncut sheet
Formats	Strip(3mm)Device(4mm) uncut sheet
Place of Origen	China
Specimen	swab
Read Time	15 minutes
Shelf life	2 years
Package	25 device/box or 50 strip/Box
Storage	2℃-30℃

For professional in vitro diagnostic use only

【INTENDED USE】

The Influenza A+B Rapid Test Device is a rapid chromatographic immunoassay for the qualitative detection of influenza A and B antigens in nasal swab or throat swab or nasal aspirate specimens. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections.

【PRINCIPLE】

The Influenza A+B Rapid Test Device (Swab/Nasal Aspirate) is a qualitative, lateral flow immunoassay for the detection of Influenza A and Influenza B nucleoproteins in nasal swab, throat swab or nasal aspirate specimens. In this test, antibody specific to the Influenza A and Influenza B nucleoproteins is separately coated on the test line regions of the test Device. During testing, the extracted specimen reacts with the antibody to Influenza A and/or Influenza B that are coated onto particles. The mixture migrates up the membrane to react with the antibody to Influenza A and/or Influenza B on the membrane and generate one or two colored lines in the test regions. The presence of this colored line in either or both of the test regions indicates a positive result. To serve as a procedural control, a colored line will always appear in the control region if the test has performed properly

Sensitivity, Specificity and Accuracy

The Influenza A+B Rapid Test Device (Swab/Nasal Aspirate) has been evaluated with specimens obtained from the patients. RT-PCR is used as the reference method for the Influenza A+B Rapid Test Device (Swab/Nasal Aspirate). Specimens were considered positive if RT-PCR indicated a positive result. Specimens were considered negative if RT-PCR indicated a negative result Nasal Swab Specimen.

Nasal Swab Specimen

		Type A			Type B
		RT-PCR		Total	RT-PCR		Total
		Positive	Negative		Positive	Negative
Flu A+B Rapid Test Strip	Positive	100	2	102	85	2	87
	Negative	1	180	181	2	200	202
Total		101	182	283	87	202	289
Relative Sensitivity		99.0%			97.7%
Relative Specificity		98.9%			99.0%
Accuracy		98.9%			98.6%

Throat Swab Specimen

		Type A			Type B
		RT-PCR		Total	RT-PCR		Total
		Positive	Negative		Positive	Negative
Flu A+B Rapid Test Device	Positive	58	1	59	65	1	66
	Negative	3	150	153	4	162	166
Total		61	151	212	69	163	232
Relative Sensitivity		95.1%			94.2%
Relative Specificity		99.3%			99.4%
Accuracy		98.1%			97.8%

Nasal Aspirate Specimen

		Type A			Type B
		RT-PCR		Total	RT-PCR		Total
		Positive	Negative		Positive	Negative
Flu A+B Rapid Test Device	Positive	46	2	48	94	1	95
	Negative	0	241	241	2	158	160
Total tal tal		46	243	289	96	159	255
Relative Sensitivity		100%			97.9%
Relative Specificity		99.2%			99.4%
Accuracy		99.3%			98.8%

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Influenza A+B Rapid Test Uncut Sheet Nasopharyngeal Swab Rtk Images

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