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Highly Accurate Flourescence Immunoassay Test cassette for respiratory illness - RSV Antigen Detection

Basic Information
Brand Name: ALLTEST Novatrend Plus
Model Number: FI RSV 502
Minimum Order Quantity: N/A
Price: negotiation
Specimen: Swab Storage: 4-30℃
Time To Results: 15 Minutes Oem: Available
Detection Method: Fluorescence Immunoassay Sensitivity: High
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The RSV Test Cassette (Nasopharyngeal Swab/Nasal Aspirate) is intended for in vitro
detection of Respiratory Syncytial Virus antigens in nasopharyngeal swab or nasal
aspirate specimens. It is intended to aid in the rapid differential diagnosis of
Respiratory Syncytial Virus viral infections.
【SUMMARY】
Respiratory Syncytial Virus (commonly known as „RSV‟), which causes infection of the
lungs and breathing passages, is a major cause of respiratory illness in young
children. In adults, it may only produce symptoms of a common cold, such as a stuffy
or runny nose, sore throat, mild headache, cough, fever, and a general feeling of
being ill. But in premature babies and kids with diseases that affect the lungs, heart,
or immune system, RSV infections can lead to other more serious illnesses. 1 RSV is
highly contagious and can be spread through droplets containing the virus when
someone coughs or sneezes. It also can live on surfaces (such as countertops or
doorknobs) and on hands and clothing, so it can be easily spread when a person
touches something contaminated. RSV can spread rapidly through schools and
childcare centers. Babies often get it when older kids carry the virus home from school
and pass it to them. Almost all kids are infected with RSV at least once by the time
they're 2-3 years old. RSV infections often occur in epidemics that last from late fall
through early spring. Respiratory illness caused by RSV such as bronchiolitis or
pneumonia — usually lasts about a week, but some cases may last several weeks.
The RSV Test cassette (Nasopharyngeal Swab/Nasal Aspirate) qualitatively detects
the presence of Respiratory Syncytial Virus antigen in Nasopharyngeal swab or nasal
aspirate specimens, providing results within 15 minutes. The test uses antibodies
specific for Respiratory Syncytial Virus to selectively detect Respiratory Syncytial
Virus antigen in nasopharyngeal swab or nasal aspirate specimens
【PRINCIPLE】
The RSV Test Cassette (Nasopharyngeal Swab/Nasal Aspirate) detects Respiratory
Syncytial Virus nucleoproteins based on Fluorescence Immunoassay. The sample
moves through the strip from sample pad to absorbent pad. If the specimen contains
Respiratory Syncytial Virus nucleoproteins, it attaches to the fluorescent
microspheres-conjugated anti- Respiratory Syncytial Virus antibodies. Then the
complex will be captured by the capture antibodies coated on the nitrocellulose
membrane (Test line). The concentration of Respiratory Syncytial Virus in the sample
correlates with the fluorescence signal intensity captured on the T line, which can be
scanned by Novatrend Plus Fluorescence Immunoassay Analyzer. The testing result of
Respiratory Syncytial Virus will display on the Novatrend Plus Fluorescence Immunoassay
Analyzer screen.
【REAGENTS】
The test cassette contains anti-Respiratory Syncytial Virus conjugated fluorophores
and anti- RSV coated on the membrane.
【PRECAUTIONS】
1. For professional in vitro diagnostic use only.
2. Do not use after the expiration date indicated on the package. Do not use the test if
the foil pouch is damaged. Do not reuse.
3. Avoid cross-contamination of specimens by using a new specimen collection
container for each specimen obtained.
4. Do not eat, drink or smoke in the area where the specimens and tests are handled.
Handle all specimens as if they contain infectious agents. Observe established
precautions against microbiological hazards throughout the procedure and follow
standard procedures for proper disposal of specimens. Wear protective clothing such
as laboratory coats, disposable gloves and eye protection when specimens are
assayed.
5. Do not interchange or mix reagents from different lots.
6. Humidity and temperature can adversely affect results.
7. Used testing materials should be discarded in accordance with local regulations.
8. Read the entire procedure carefully prior to any testing.
9. The FIATESTTM RSV Test Cassette should only be used with the Novatrend Plus
Analyzer by approved medical professionals.
【STORAGE AND STABILITY】
1. The kit should be stored at 4-30 °C until the expiry date printed on the sealed
pouch.
2. The test must remain in the sealed pouch until use.
3. Do not freeze.
4. 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.
【SPECIMEN COLLECTION AND PREPARATION】
Preparation
Before performing the test, please make sure that all components are brought to room
temperature (15-30 °C). Cold buffer solution or moisture condensation on the
membrane can lead to invalid test results.
Sample Handling
• Nasopharyngeal swab sample
Insert sterilized swab into nostril parallel to the palate and leave in place for a few
second to absorb secretions. Collect samples with nasopharyngeal (NP) swabs for
optimum results.
• Nasal Aspirate sample
Connect an aspiration catheter to an aspiration trap that is attached to an aspiration
device, insert the catheter to nasal cavity from a nostril, start the aspiration device and
then collect nasal aspirate sample. Dip a sterilized swab into the collected nasal
aspirate sample and make the specimen cling to the swab.
【MATERIALS】
Materials Provided
• Test Cassettes
• Extraction Reagent • Sterile Swabs
• Package Insert
• Workstation
• Extraction Tubes
• Extraction Tube Tips • ID Card
Materials Required But Not Provided
• Timer
• FIATESTTM Fluorescence Immunoassay Analyzer
【DIRECTIONS FOR USE】
Refer to Novatrend Plus Fluorescence Immunoassay Analyzer Operation Manual for the
complete instructions on use of the Test. The test should be conducted in room
temperature.
Allow the test, specimen, buffer and/or controls to reach room temperature (15-
30°C) prior to testing.
1. Turn on the Analyzer power. Then according to the need, select “standard test” or
“Quick test” mode.
2. Take out the ID card and insert it into the Analyzer ID Card Slot.
3. Remove the test cassette from the sealed foil pouch and use it as soon as
possible. Best results will be obtained if the assay is performed immediately after
opening the foil pouch.
4. Place the Extraction Tube in the workstation. Hold the extraction reagent bottle
upside down vertically. Squeeze the bottle and let the solution drop into the
extraction tube freely without touching the edge of the tube. Add 10 drops of
extraction reagent (Approx. 400ul) to the Extraction Tube.
5. Place the swab specimen in the Extraction Tube. Rotate the swab for
approximately 10 seconds while pressing the head against the inside of the tube to
release the antigen in the swab.
6. Remove the swab while squeezing the swab head against the inside of the
Extraction Tube as you remove it to expel as much liquid as possible from the
swab. Discard the swab in accordance with your biohazard waste disposal protocol.
7. Fit the dropper tip on top of the extraction tube. Place the test cassette on a clean
and level surface.
8. Add three drops of the solution (approx.120ul) to the sample well and then start
the timer.(Follow the illustration as below)
9. There are two test modes for Novatrend Plus Fluorescence Immunoassay Analyzer,
Standard Test mode and Quick Test mode. Please refer to the user manual of
Novatrend Plus Fluorescence Immunoassay Analyzer for details.
“Quick test” mode: After 15 minutes of adding sample, Insert the test cassette into
the Analyzer, click “QUICK TEST”, fill the test information and click "NEW TEST"
immediately. The Analyzer will automatically give the test result after a few
seconds.
“Standard test” mode: Insert the test cassette into the Analyzer immediately after
adding specimen, click “STANDARD TEST”, fill the test information and click "NEW
TEST" at the same time, The Analyzer will automatically countdown 15 minutes.
After the countdown, the Analyzer will give the result at once.
 

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