Notice: You need an Immunofluorescence Analyzer to run the tests with this kit
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INTENDED USE
The CDV-Ag test is a fluorescence immunoassay used along with an Immunofluorescence Analyzer for quantitative determination of distemper virus Antigen concentration in canine nasopharyngeal or ocular swabs. The test is used as an aid in the diagnosis and monitoring of canine distemper virus infection.
For in vitro diagnostic use only. For professional use only.
TEST PRINCIPLE
- This test employs a quantitative double antibody sandwich fluorescence immunoassay technique.
- The fluorescent signal intensity reflects the amount of CDV-Ag captured. The concentration is expressed as Tu/ml.
MATERIAL
| Material Provided | Material Required But Not Provided |
|---|---|
| Each box contains: | |
| 1. 10 individual sealed pouches, each containing: | 1. Immunofluorescence Analyzer |
| – a Test Device | 2. Timer |
| – a desiccant pouch | 3. Pipet |
| 2. One ID Chip | 4. Mesin sentrifugal |
| 3. Instructions for Use | |
| 4. 10 cotton swabs | |
| 5. 10 tubes of CDV-Ag Sample Buffer | |
| 6. 10 Tip pipet |
STORAGE AND STABILITY
- Store the test kit at 4～30℃ up to the expiration date.
- The test should operate at 18 ~ 28℃ after the Test Device opening.
- Once the pouch is opened, the test should be performed within 30 menit.
SPECIMEN COLLECTION AND PREPARATION
- The test can be performed with the rectal swab.
- Collection of rectal sample: insert the swab into the rectum of the feline and rotate the swab close to the inner wall 3 ~ 5 waktu. The sample volume is about 1/2 ~ 2/3 cotton tip.
- Optimally, the test should be performed immediately after the specimen collection. If the test cannot be performed within 3 jam after collection, store the specimen at 2～8℃ for no longer than 48 jam. For long-term storage, specimens shall be kept below -20℃.
Bring all materials to room temperature before use. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly. Only clear, non-hemolyzed specimens can be used.
TEST PROCEDURE
Refer to the Immunofluorescence Analyzer Operation Manual for complete instructions for use of the Test device.
- Set a Test Device on a clean, level horizontal table.
- Insert the ID Chip into the meter, and click“Read ID chip”. Make sure that the Test Device lot No. matches with ID Chip No.
- Place the rectal swab with the sample into the CDV-Ag Sample Buffer. Stir thoroughly and mesin sentrifugal untuk 1 menit (3000 ~ 5000rpm).
- Pipet 100 Maku of mixed sample to add into the sample well (S) of the test device. Avoid forming bubbles.
- Test mode: a or b
A) Standard Test: Click “Standard Test”, insert the Test Device into the device holder of the meter right after adding the sample to the sample well, and click “Start Test”. Select sample type “Rectal Swab”. The meter will start to countdown and read the test result automatically.
B) Quick Test: Click “Quick Test”, and start the timer right after adding the sample mixture to the sample well. Leave the Test Device at room temperature (18 ~ 28℃) untuk 10 menit. Kemudian insert the test device immediately insert the holder of the meter and click “Start Test”. Select sample type “Rectal Swab”. The instrument will scan the Test Device automatically and show the test result.
- Results are displayed on the main screen, print automatically, or be printed by clicking “Print”.
QUALITY CONTROL
Each CDV-Ag Rapid Quantitative Test contains an internal control for routine quality control requirements. This internal quality control is performed each time a patient sample is tested, If an invalid result from the internal control occurs, the meter will display an error message, indicating that another test should be conducted.
INTERPRETATION
Reference range of CDV-Ag in canine rectal swab.
- Detection range: 4.0 ~ 640 Tu/ml
- Reference range:
| Hasil (Tu/ml) | Suggestion |
|---|---|
| ≤ 8 | Negatif (-) |
| 8 ~ 15 | Suspected (±) |
| 15 ~ 40 | Weak Positive (+) |
| 40 ~ 200 | Medium Positive (++) |
| > 200 | Strong Positive (+++) |
Each laboratory should establish a reference range that is representative of the population to be evaluated.
WARNINGS AND LIMITATIONS OF THE PROCEDURE
- This kit is for in vitro diagnostic use only.
- Inspect the packaging and labels before use. Do not use it if the pouch is broken, torn, or not well sealed, or if the vial looks damaged or leaked.
- Do not use the test device beyond the expiration date.
- One pipette tip should be used for one specimen only.
- There is the possibility that factors such as technical or procedural errors, as well as additional substances in blood specimens that are not listed in the text, may interfere with the test and cause erroneous results.
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