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Respiratory Syncytial Virus RSV Rapid Test Diagnostic Test Kit with 24 Months Shelf Life

Basic Information
Place of Origin: China
Brand Name: Dewei
Certification: ISO, CE
Model Number: RSV-DS02
Minimum Order Quantity: 5000 units
Price: Negotiable
Packaging Details: 25test/box
Delivery Time: in 20 days
Payment Terms: L/C, T/T, Western Union
Supply Ability: 500,000pcs/day
Detail Information
Sample: Swab Type: Cassette
Certificate: ISO, CE Origin: China
Shelf Life: 24 Months Usage: Professional Use
Highlight:

Respiratory Syncytial Virus Rapid Test Kit

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RSV Rapid Test Diagnostic Test Kit


Product Description

Respiratory Syncytial Virus (RSV) Rapid Test Diagnostic Test Kit

 

 
【INTENDED USE】
The RSV Antigen Test Kit is qualitative in-vitro immunoassay for the rapid detection of respiratory syncytial virus (RSV) antigen directly from nasopharyngeal swab specimens for symptomatic pediatric patients. The test is intended for use as an aid in the rapid diagnosis of acute RSV infection. Negative results do not preclude RSV infection and should not be used as the only basis for treatment or for other management decisions. A negative test is presumptive. It is recommended that negative test results are confirmed by cell culture. Any reactive specimen with the RSV Cassette Rapid Test must be confirmed with alternative testing method(s).
 
 
 
【INTRODUCTION】
RSV is a causative agent of highly contagious, acute, viral infection of the respiratory tract in pediatric populations. Respiratory syncytial virus is a single-stranded RNA virus, spherical with a medium-sized diameter 80-150 nm. The virus could easily affect infants with bronchiolitis and bronchiolar pneumonia, it is cause for 60% of acute infant asthmatic bronchitis and pneumonia. Adolescents and adults are mainly affected by upper respiratory tract infection.
 
 
 
【PRINCIPLE】
The RSV Antigen Test Kit is a qualitative lateral flow immunoassay technology for the rapid detection of RSV antigen in human nasopharyngeal samples. During the test, the sample is dropped into the sample well of the reagent, and the chromatography is performed under the capillary effect. The human RSV antigen in the sample binds to the colloidal gold-labeled RSV monoclonal antibody I, diffuses to the test area, and is captured by coated RSV monoclonal antibody II, forming a complex to aggregate in the test area (T); the quality control area is coated with goat anti-mouse IgG antibody, which captures the colloidal gold-labeled antibody to form a complex and aggregate in the quality control area (C). The highly specific antigen antibody reaction and colloidal gold immunochromatography technology are combined to qualitatively detect the content of RSV in human nasopharyngeal samples.

 

 

 
【CONTENTS】
• Rapid test.
• Extraction buffer and tube.
• Swab.
• Instruction for use.
 
 
 
【STORAGE AND STABILITY】
• The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch.
• The test must remain in the sealed pouch until use.
• Keep away from direct sunlight, moisture and heat.
• Do not freeze.
• Care should be taken to protect the components of the kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipment, containers or reagents can lead to false results.
 
 
 
【SAMPLE COLLECTION AND STORAGE】
Consider any materials of human origin as infectious and handle them using standard biosafety procedures. Specimen collection Use the nasopharyngeal swab supplied in the kit. It is important to obtain as much secretion as possible. Therefore, to collect a nasopharyngeal swab sample, carefully insert the sterile swab into the nostril that presents the most secretions under visual inspection. Keep the swab near the septum floor of the nose while gently pushing the swab into the posterior nasopharynx. Rotate the swab several times, and then remove it from the nasopharynx.
Sample processing
1. Add 20 drops (about 500μL) of the Extraction reagent solution to the Extraction Tube.
2. Immediately place the patient swab sample into the Extraction Tube. Roll the swab a minimum of three times while pressing the head against the bottom and side of the Extraction Tube. Keep the swab in the tube for one minute.
3. Express all liquid from the swab head by rolling it against the inside of the Extraction Tube whilst the swab is being removed.
4. Discard the swab in accordance with your biohazard waste disposal protocol. Then put the dropper onto the top of the Extraction Tube, which is now ready to use.
 
 
 
【PRECAUTIONS】
• For professional in vitro diagnostic use only.
• Do not use after expiration date indicated on the package. Do not use the test if its foil pouch is damaged. Do not reuse tests.
• Avoid cross-contamination of specimens by using a new specimen collection container for each specimen obtained.
• Read the entire procedure carefully prior to performing any tests.
• Do not eat, drink or smoke in the area where the specimens and kits are handled. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the procedure and follow the standard procedures for proper disposal of specimens. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
• Buffered Saline contains sodium azide which may react with lead or copper plumbing to form potentially explosive metal azides. When disposing of buffered saline or extracted samples, always flush with copious quantities of water to prevent azide build up.
• Do not interchange or mix reagents from different lots.
• Humidity and temperature can adversely affect results.
• The used testing materials should be discarded in accordance with local, state and/or federal regulations.
 
 
 
【OPERATION】
Bring tests, specimens, buffer and/or controls to room temperature (15- 30°C) before use.
1.Insert the tip onto tube membrane, take out the tip after membrane’s puncture.
2.Collect the swab sample according to above instruction.
3.Roll the swab at least 6 times while pressing the head against the bottom and side of the extraction tube. Leave the swab into the extraction tube for 1 minute. Squeeze the tube by fingers from outside of the tube to immerse the swab. Remove the swab. The extracted solution will be used as test sample.
4.Put the tip onto the tube, and take out its cap.
5.Add 2 drops of the mixed sample to each sample wells of the cassette and read the results in 15 minutes.
 
 
 
INTERPRETATION OF RESULTS
POSITIVE:
The presence of two lines as control line (C) and test line (T) within the result window indicates a positive result.
NEGATIVE:
The presence of only control line (C) within the result window indicates a negative result.
INVALID:
If the control line (C) is not visible within the result window after performing the test, the result is considered invalid. Some causes of invalid results are because of not following the directions correctly or the test may have deteriorated beyond the expiration date. It is recommended that the specimen be re-tested using a new test.
 
 
 

For further operation or performance details, please refer to final instruction manual.

 

 

 

Contact Details
Bonnie He

Phone Number : +8613030247038

WhatsApp : +8615267039708