Basic Info.
Model NO.
HFLU015GA
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 - Foil pouches, each contains one test cassette, and one desiccant bag
- Assay buffer tubes (0.5ml each) with tips
- Disposable Sampling Swabs
- Paper tube holder
- Instruction for use
- 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:
- 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.
- Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure.
PERFORMANCE CHARACTERISTICS
1. Sensitivity, Specificity and AccuracyThe 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 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) | 1.2X104 TCID50/mL |
| Influenza A (H3N2) | 1.4X104 TCID50/mL |
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.
