Influenza a Antigen Rapid Test

• Customization: Available
• Type: Detection Card
• Syringe: None
• Model NO.: HFLU015GA
• Blood Sampling Needle: None
• Breathing Pattern: None
• Animal Anesthesia Machine Control Method: None
• Assay Time: 5-10 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

INTENDED USE
The Influenza A Antigen Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of Influenza A antigen 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. Assay buffer tubes (0.5ml each) with tips
3. Disposable Sampling Swabs
4. Paper tube holder
5. Instruction for use

Materials Required But Not Provided

1. Timer

INTERPRETATION OF RESULTS

POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).
NEGATIVE: Only one colored band appears in the control region (C). No apparent colored band appears in the test region (T).
INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.
NOTE:

1. The intensity of color in the test region (T) may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of color in the test region should be considered positive. Note that this is a qualitative test only, and cannot determine the concentration of analytes in the specimen.
2. Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure.

PERFORMANCE CHARACTERISTICS

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

Method		Gold standard reagent (PCR)		Total Results
Influenza A Antigen Rapid 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%)
2. Limit of Detection (LOD)
The limits of detection of the Influenza A Antigen Rapid Test has been studied.     

Pathogens	Limit of deteftion (LOD)
Influenza A (H1N1)	1.2X10^4 TCID50/mL
Influenza A (H3N2)	1.4X10^4 TCID50/mL

3. Cross-reactivity
No cross reaction was observed when samples enriched with the following respiratory symptoms relative pathogens: Influenza B, 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 Antigen Rapid Test have been tested using these specimens. The specimens were correctly identified >99% of the time.