Description
1. Specification
Tests per box: 10 tests.
Catalog number: MG – CA – R010.
2. Intended Use
This is a fluorescence immunoassay. When used with an Immunofluorescence Analyzer, it quantitatively measures canine parvovirus antigen (CPV – Ag) concentration in rectal swabs.
It helps diagnose and monitor canine parvovirus infections.
For in vitro diagnostic use only, and professional use only.
3. Test Principle
Uses a quantitative double antibody sandwich fluorescence immunoassay technique.
The intensity of the fluorescent signal correlates with the amount of CPV – Ag captured.
Concentration is expressed in Tu/ml.
4. Materials
Provided:
10 individual sealed pouches. Each contains:
Test Device
Desiccant pouch
One ID Chip
Instructions for Use
10 cotton swabs
10 tubes of CPV – Ag Sample Buffer
10 Pipette tips
Required but not provided:
Immunofluorescence Analyzer
Timer
Pipette
Centrifuge
5. Storage and Stability
Store the test kit at 4–30°C until the expiration date.
After opening the Test Device, perform the test at 18–28°C.
Once the pouch is opened, do the test within 30 minutes.
6. Specimen Collection and Preparation
The test uses a rectal swab.
Rectal Sample Collection:
Insert the swab into the canine’s rectum.
Rotate the swab 3–5 times near the inner wall.
Ensure the sample volume covers 1/2–2/3 of the cotton tip.
Specimen Storage:
Test right after collection if possible. If not, store at 2–8°C for up to 48 hours. For longer storage, keep below -20°C.
Preparation Before Testing:
Bring all materials to room temperature before testing.
Thaw and mix frozen specimens thoroughly. Don’t freeze and thaw samples repeatedly.
Only use clear, non – hemolyzed specimens.
7. Test Procedure
Follow the Immunofluorescence Analyzer Operation Manual.
Steps:
Place the Test Device on a clean, level surface.
Insert the ID Chip into the meter and click “Read ID Chip”. Make sure the Test Device lot number matches the ID Chip number.
Put the rectal swab into the CPV – Ag Sample Buffer. Stir well, 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 bubbles.
Test Mode Options:
Standard Test:
Click “Standard Test”.
Insert the Test Device into the meter holder right after adding the sample.
Select “Rectal Swab” as the sample type. The meter will read the result automatically.
Quick Test:
Click “Quick Test” and start the timer right 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 scan and display the result automatically.
Results: Shown on the main screen, printed automatically, or printed by clicking “Print”.
8. Quality Control
Each CPV – Ag Rapid Quantitative Test has an internal control for quality control. It’s performed every time a patient sample is tested.
If an invalid result is detected, the meter will show an error message, meaning the test needs to be repeated.
9. Interpretation
Detection Range: 4.0 ~ 640 Tu/ml.
Reference Range:
Results ≤ 8 Tu/ml: Negative (-).
Results 8 ~ 15 Tu/ml: Suspected (±).
Results 15 ~ 40 Tu/ml: Weak Positive (+).
Results 40 ~ 200 Tu/ml: Medium Positive (++).
Results > 200 Tu/ml: Strong Positive (+++).
Each laboratory should set a reference range that represents the population being evaluated.
10. Warnings and Limitations
This kit is for in vitro diagnostic use only.
Check the packaging before use. Don’t use if the pouch is damaged or components are compromised.
Don’t use the test device after the expiration date.
Use a new pipette tip for each specimen.
Factors like technical errors or substances in the blood can interfere with the test and cause wrong results.
