Key attributes
SPECIFICATION
10 Test/Box
CAT No. MG-CA-R005
INTENDED USE
The CCV-Ag test is a fluorescence immunoassay designed for use with an Immunofluorescence Analyzer to quantitatively measure the concentration of canine distemper virus (CCV) antigen in nasopharyngeal or ocular swabs from dogs. This test aids in diagnosing and monitoring canine distemper virus infections and assessing the effectiveness of vaccination.
For in vitro diagnostic use only. For professional use only.
TEST PRINCIPLE
The test utilizes a quantitative double antibody sandwich fluorescence immunoassay technique. The fluorescent signal intensity corresponds to the amount of CCV antigen captured, with results expressed in Tu/ml.
MATERIALS PROVIDED
| Contents | Quantity |
|---|---|
| Individual Sealed Pouches | 10 |
| – Test Device | Per pouch |
| – Desiccant Pouch | Per pouch |
| ID Chip | 1 |
| Instructions for Use | 1 |
| CCV-Ag Sample Buffer Tubes | 10 |
| Cotton Swabs | 10 |
| Pipette Tips | 10 |
Material Required But Not Provided:
Immunofluorescence Analyzer
Timer
Pipette
Centrifuge
STORAGE AND STABILITY
Store the test kit at 4–30°C until the expiration date.
After opening the Test Device, operate at 18–28°C.
Perform the test within 30 minutes of opening the pouch.
SPECIMEN COLLECTION AND PREPARATION
The test can be performed using rectal swabs.
Collection Procedure: Insert the swab into the rectum, rotating it 3–5 times near the inner wall. The sample volume should be approximately 1/2 to 2/3 of the cotton tip.
Ideally, conduct the test immediately after sample collection. If testing cannot be performed within 3 hours, store the specimen at 2–8°C for up to 48 hours. For long-term storage, keep specimens below -20°C.
Allow all materials to reach room temperature before use. Thaw frozen specimens completely and mix well before testing. Avoid repeated freezing and thawing. Only clear, non-hemolyzed specimens should be used.
TEST PROCEDURE
Refer to the Immunofluorescence Analyzer Operation Manual for detailed instructions on using the Test Device.
Place the Test Device on a clean, level surface.
Insert the ID Chip into the meter and select “Read ID chip.” Ensure that the Test Device lot number matches the ID Chip number.
Place the rectal swab sample into the CCV-Ag Sample Buffer, mix thoroughly, and centrifuge for 1 minute (3000–5000 rpm).
Pipette 100 μl of the mixed sample into the sample well (S) of the Test Device. Avoid bubbles.
Test Mode Options:
a) Standard Test: Select “Standard Test,” insert the Test Device into the meter holder immediately after adding the sample, and click “Start Test.” Choose “Rectal Swab” as the sample type. The meter will count down and automatically read the result.
b) Quick Test: Select “Quick Test,” start the timer immediately after adding the sample mixture, and leave the Test Device at room temperature (18–28°C) for 10 minutes. Insert the Test Device into the meter holder and click “Start Test.” Choose “Rectal Swab” as the sample type. The meter will scan the Test Device and display the result.
Results will appear on the main screen, print automatically, or can be printed by selecting “Print.”
QUALITY CONTROL
Each CCV-Ag Rapid Quantitative Test includes an internal control for routine quality assurance. If the internal control fails, the meter will display an error message, prompting a retest.
INTERPRETATION
Reference Range for CCV-Ag in Canine Rectal Swabs:
Detection Range: 4.0–640 Tu/ml
Reference Range:
| Result (Tu/ml) | Suggestion |
|---|---|
| ≤ 8 | Negative (-) |
| 8 – 15 | Suspected (±) |
| 15 – 40 | Weak Positive (+) |
| 40 – 200 | Medium Positive (++) |
| > 200 | Strong Positive (+++) |
Each laboratory should establish its own reference ranges based on the population being evaluated.
WARNINGS AND LIMITATIONS OF THE PROCEDURE
This kit is for in vitro diagnostic use only.
Inspect packaging and labels before use. Do not use if the pouch is damaged or the vial is leaking.
Do not use the test device past its expiration date.
Use a new pipette tip for each specimen to prevent cross-contamination.
Technical or procedural errors, as well as substances not listed in the instructions, may affect the test results and cause inaccuracies.
