Key attributes
SPECIFICATION
10 Tests/Box
Catalog No.: MG-CA-R022
INTENDED USE
The CAV-Ab test is a fluorescence immunoassay designed for use with an Immunofluorescence Analyzer to quantitatively measure adenovirus antibody (CAV-Ab) levels in serum or plasma. This test assists in evaluating the effectiveness of pet vaccinations, determining the need for re-vaccination, and monitoring canine adenovirus infection.
For in vitro diagnostic use only. For professional use only.
TEST PRINCIPLE
The test utilizes a quantitative double antigen sandwich fluorescence immunoassay technique.
The intensity of the fluorescent signal indicates the amount of CAV-Ab 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 |
| CAV-Ab Sample Buffer Tubes | 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.
Operate the test at 18–28°C after opening the Test Device.
Perform the test within 30 minutes of opening the pouch.
SPECIMEN COLLECTION AND PREPARATION
The test can be performed on serum or plasma.
Separate serum or plasma (EDTA anticoagulant is recommended) from blood within 3 hours of collection. If the specimen is severely hemolyzed, obtain a new specimen.
Ideally, conduct the test immediately after specimen collection. If testing cannot be performed within 3 hours, store the specimen at 2–8°C for up to 72 hours. For long-term storage, keep specimens below -20°C.
Bring all materials to room temperature before use. Thaw frozen specimens completely and mix well before testing. Avoid repeated freezing and thawing. Use only clear, non-hemolyzed specimens.
TEST PROCEDURE
Refer to the Immunofluorescence Analyzer Operation Manual for complete 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” to verify that the Test Device lot number matches the ID Chip number.
Pipette 50 μl of the prepared sample into the CAV-Ab Sample Buffer and mix gently. Avoid vigorous agitation and foaming.
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 “Serum/Plasma” 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, and leave the Test Device at room temperature (18–28°C) for 10 minutes. Insert the device into the meter holder and click “Start Test.” Choose “Serum/Plasma” 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 clicking “Print.”
QUALITY CONTROL
Each CAV-Ab Rapid Quantitative Test includes an internal control for routine quality checks. This control is executed with each patient sample. If an invalid result occurs, the meter will display an error message, indicating that a retest is required.
INTERPRETATION
Reference Range for CAV-Ab in Canine Serum or Plasma:
Detection Range: 4.0–640 Tu/ml
Reference Range:
| Result (Tu/ml) | Level | Interpretation |
|---|---|---|
| ≤ 8 | 0 | No antibody protection; vaccination recommended. |
| 8 – 18 | 1 | Weak antibody protection; consider supplementary immunization or adjust vaccination program. |
| 18 – 40 | 2 | Moderate antibody protection. |
| 40 – 80 | 3 | Moderate antibody protection; monitor antibody levels every 6 months. |
| 80 – 160 | 4 | Strong antibody protection; test annually to assess vaccine effectiveness. |
| > 160 | 5 | Strong antibody protection; annual testing recommended. |
Note: If the pet has not been vaccinated but the result exceeds Level 1, it may indicate past infection.
Each laboratory should establish reference ranges that are representative of 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 if the vial is leaking.
Do not use the test device after its expiration date.
Use a new pipette tip for each specimen to avoid contamination.
Technical or procedural errors and additional substances in blood specimens not listed in the instructions may interfere with the test and result in erroneous outcomes.
