Colloidal Gold Cassette Influenza a+B Antigen Rapid Test

• Customization: Available
• Type: Detection Card
• Syringe: None
• Model NO.: HFLU014GAB
• Blood Sampling Needle: None
• Breathing Pattern: None
• Animal Anesthesia Machine Control Method: None
• Assay Time: 10-15 Minutes
• Specimen: Human Nasopharyngeal Swab, or Oropharyngeal Swab
• 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

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.



 

Principles

PRINCIPLE

The Influenza A+B Antigen Rapid Test is consist with one test strips which could be observed in the window of the rapid test device. The strip is based on sandwich method immunochromatographic assay. 



 

Test Procedure

TEST PROCEDURE


Allow the test device, specimen, buffer, and/or controls to reach room temperature (10 - 30°C) prior to testing.

 

1. Remove the test device from the foil pouch and use it within one hour. Best results will be obtained if the test is performed immediately after opening the foil pouch.
2. Place the test device on a clean and horizontal surface. Reverse the Extraction tube, extrude 2 - 3 drops (100μl) of the prepared specimen into the specimen well (S) of the test device 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.
 

 

Company Profile

COMPANY PROFILE
 

 

Hangzhou lmmuno Biotech Co., Ltd is the original organization in lmmuno Group, which has engaged in this industry for more than 10 years. The team of Hangzhou lmmuno Biotech has developed a series of proteins and rapid test kits for the in vitro diagnostic industry in early stage.In the past few years we focused on the  human medical diagnostic field which mainly cover the following directions: rapid tests for vector-borne diseases(VBDs), rapid tests for sexually transmitted diseases (STDs), rapid tests for respiratory system diseases, rapid tests for digestive system diseases and rapid test for drug of abuse. For now, we are paying more attention to the diagnosis of neglected tropical diseases (NTDs). With strong R&D ability we are capable to develop and produce test kits for customers in a short time, and our product quality is ahead of similar products in the market.

 

Packaging & Shipping