Respiratory Syncytial Virus Antigen Rapid Test

• Customization: Available
• Type: Detection Card
• Syringe: None
• Model NO.: HRSV022G
• 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 Respiratory Syncytial Virus Antigen Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of Respiratory Syncytial Virus (RSV) antigen in human nasopharyngeal swab, or oropharyngeal swab specimen.

SUMMAR
MATERIALS

Materials Provided

Individually packed test devices	Workstation
Buffer tubes with dropper tips	Package insert
Disposable Sampling Swabs
Materials Required but Not provided
Timer

TEST PROCEDURE

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

1. Bring the pouch to room temperature before opening. 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 8-10 minutes. Do not interpret the result after 15 minutes.

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

Method		PCR		Total Results
Respiratory Syncytial Virus Antigen Rapid Test	Results	Positive	Negative
	Positive	94	3	97
	Negative	2	147	149
Total Result		96	150	246

Relative Sensitivity: 97.92% (95%CI: 92.68%~99.75%)  
Relative Specificity: 98.00% (95%CI:94.27%~99.59%) 
Accuracy: 97.97% (95%CI:95.32%~99.34%)
Cross-reactivity
No cross reaction was observed when samples enriched with the following respiratory symptoms relative pathogens: Influenza A, Influenza B, SARS-COV2, Human coronavirus (229E, HKU1, OC43 and NL63), Parainfluenza virus (type 1-4), Mycoplasma pneumoniae, adenovirus, Neisseria meningitidis, mumps virus, Staphylococcus aureus, Streptococcus pneumoniae.
Interfering Substances: 
No interference was observed to the test strip, with the following compounds: Alpha-interferon, purified Mucin, whole blood, budesonide nasal spray, one, Oxymetazoline, HAMA, Fluticason propionate. 
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 Respiratory Syncytial Virus Antigen Rapid Test have been tested using these specimens. The specimens were correctly identified >99% of the time.