Key attributes
SPECIFICATION
10 Tests/Box
Cat. No.: MG-CA-R002
The CPV-Ag test is a fluorescence immunoassay used in conjunction with an Immunofluorescence Analyzer for the quantitative determination of canine parvovirus antigen concentration in rectal swabs. It aids in the diagnosis and monitoring of canine parvovirus infection.
For in vitro diagnostic use only. For professional use only.
This test utilizes a quantitative double antibody sandwich fluorescence immunoassay technique. The intensity of the fluorescent signal correlates with the amount of CPV-Ag captured. The concentration is expressed in Tu/ml.
| Material Provided | Material Required but Not Provided |
|---|
10 individual sealed pouches, each containing:
Test Device
Desiccant pouch
One ID Chip
Instructions for Use
10 cotton swabs
10 tubes of CPV-Ag Sample Buffer
10 Pipette tips |
Immunofluorescence Analyzer
Timer
Pipette
Centrifuge
Store the test kit at 4～30°C up to the expiration date.
Test should operate at 18～28°C after the Test Device is opened.
Once the pouch is opened, perform the test within 30 minutes.
The test can be performed using a rectal swab.
Rectal Sample Collection:
Insert the swab into the rectum of the canine.
Rotate the swab 3–5 times near the inner wall.
The sample volume should cover 1/2–2/3 of the cotton tip.
Test immediately after specimen collection if possible. If not, store the specimen at 2–8°C for up to 48 hours. For longer storage, keep specimens below -20°C.
Before testing, bring all materials to room temperature. Thaw and mix frozen specimens thoroughly. Do not repeatedly freeze and thaw samples. Only clear, non-hemolyzed specimens can be used.
Follow the Immunofluorescence Analyzer Operation Manual for complete instructions.
Place the Test Device on a clean, level surface.
Insert the ID Chip into the meter, and click "Read ID Chip." Ensure that the Test Device lot number matches the ID Chip number.
Place the rectal swab into the CPV-Ag Sample Buffer. Stir thoroughly, then centrifuge for 1 minute (3000–5000 rpm).
Pipette 100 μl of the mixed sample into the sample well (S) of the test device. Avoid forming bubbles.
Test Mode Options:
Standard Test:
Click "Standard Test."
Insert the Test Device into the meter holder immediately after adding the sample.
Select "Rectal Swab" as the sample type.
The meter will automatically read the test result.
Quick Test:
Click "Quick Test" and start the timer immediately after adding the sample.
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."
The instrument will automatically scan the Test Device and display the result.
Results:
Displayed on the main screen, printed automatically, or printed by clicking "Print."
Each CPV-Ag Rapid Quantitative Test includes an internal control for quality control purposes. This control is performed each time a patient sample is tested. If an invalid result is detected, the meter will display an error message, indicating the need to repeat the test.
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 a reference range that is representative of the population to be evaluated.
This kit is for in vitro diagnostic use only.
Inspect packaging before use. Do not use if the pouch is damaged or if any components are compromised.
Do not use the test device after the expiration date.
Use a new pipette tip for each specimen.
Factors such as technical errors or substances in the blood may interfere with the test and cause erroneous results.
