Influenza a+B Antigen Combo Test

• Customization: Available
• Type: Detection Card
• Used for: Influenza a & B Test
• Model NO.: HFLU014GAB
• Specimen: Nasopharyngeal Swab, or Oropharyngeal Swab
• Assay Time: 10-15 Minutes
• Delivery Time: 3~5days After Get Payment
• Payment: T/T, Western Union, Paypal
• Customized: Accpet
• Transport Package: Carton
• Specification: 10Tests/Kit
• Trademark: PETX
• Origin: Hangzhou
• HS Code: 38220010
• Production Capacity: 5000000PCS/Year

Product Description

Introduction

INTENDED USE
The Influenza A+B Antigen Combo Test is a rapid chromatographic immunoassay for the qualitative detection of Influenza A and Influenza B antigens in human nasopharyngeal swab, or oropharyngeal swab specimen in individuals who are suspected of respiratory viral infection consistent with flu symptoms.



MATERIALS

Materials Provided

1. Foil pouches, each contains one test cassette, and one desiccant bag

2. Extraction tubes and tips

3. Disposable Sampling Swabs

4. Paper tube holder

5. Assay buffe

6. Instruction for use
 

Materials Required But Not Provided
1. Specimencollectioncontainers
2. Timer



 

Test Procedure

Allow the rapid test, specimen, buffer, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.

1. Remove the rapid test cassette from the sealed pouch and use it as soon as possible.
2. Place the test device on a clean and horizontal surface. Reverse the specimen collection tube, extrude 3 drops of the prepared specimen into the specimen well (S) of the test cassette and start the timer.
3. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 15 minutes.

 

INTERPRETATION OF RESULTS

 

Performance

PERFORMANCE CHARACTERISTICS

1. Sensitivity, Specificity and Accuracy
The Influenza A+B Antigen Combo Test has been compared with a commercial gold standard reagent (PCR). The result showed the relative sensitivity and specificity

1. Influenza A part

Method		Gold standard reagent (PCR)		Total Results
Influenza A+B Antigen Combo Test	Results	Positive	Negative
	Positive	165	0	165
	Negative	11	376	387
Total Result		176	376	552

Relative Sensitivity: 93.75% (95%CI: 89.04%~96.59%)  
Relative Specificity: >99.99% (95%CI:98.78%~100.00%) 
Accuracy: 98.01% (95%CI:96.42%~98.93%)

1. Influenza B part

Method		Gold standard reagent (PCR)		Total Results
Influenza A+B Antigen Combo Test	Results	Positive	Negative
	Positive	63	0	63
	Negative	5	480	485
Total Result		68	480	548

Relative Sensitivity: 92.65% (95%CI: 83.54%~97.19%)  
Relative Specificity: >99.99% (95%CI:99.04%~100.00%) 
Accuracy: 99.09% (95%CI:97.82%~99.67%)


2. Limit of Detection (LOD)
The limits of detection of the Influenza A+B Antigen Combo Test has been studied.     

Pathogens	Limit of deteftion (LOD)
Influenza A (H1N1)	1.2X10^4 TCID50/mL
Influenza B	1.5X10^5 TCID50/mL

3. Cross-reactivity
No cross reaction was observed when samples enriched with the following respiratory symptoms relative pathogens:  Human coronavirus (229E, HKU1, OC43 and NL63), Parainfluenza virus (type 1-4), Mycoplasma pneumoniae, adenovirus, respiratory syncytial virus, Neisseria meningitidis, mumps virus, Staphylococcus aureus, Streptococcus pneumoniae.

4. Interfering Substances: 
No interference was observed to the test strip, with the following compounds: Alpha-interferon, purified Mucin, whole blood, budesonide nasal spray, Oxymetazoline, HAMA, Fluticason propionate.
 
5.Precision (Repeatability & Reproducibility)
Intra-Assay
Within-run precision has been determined by using 15 replicates of three specimens: a negative, a weak positive and a positive standard. The specimens were correctly identified >99% of the time.

Inter-Assay
Between-run precision has been determined by 15 independent assays on the same two specimens: a negative, a weak positive and a positive standard. Three different lots of the Influenza A+B Antigen Combo Test have been tested using these specimens. The specimens were correctly identified >99% of the time.