Notice: You need an Immunofluorescence Analyzer to run the tests with this kit
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SPECIFICATION
10 Test/Box
Cat.No.:MG-CA-R032
INTENDED USE
The CDV/CPV/CAV Ab test is a fluorescence immunoassay used along with an Immunofluorescence Analyzer for quantitative determination of the antibody concentration of panleukopenia virus, distemper virus, and adenovirus in serum or plasma specimens. The test may offer a reference of antibody titer levels after pets’ immune vaccine and determine whether the pets need to be immune again. Another use of the test is an aid in the diagnosis and monitoring of the infection of canine panleukopenia virus, canine distemper virus, and canine adenovirus.
For in vitro diagnostic use only. For professional use only
TEST PRINCIPLE
- This test employs a quantitative double antigen sandwich fluorescence immunoassay technique.
- The fluorescent signal intensity reflects the amount of CDV-Ab, CPV-Ab, CAV-Ab captured. The concentration is expressed as Tu/ml.
MATERIAL
Material Provided | Material Required But Not Provided |
---|---|
10 individual sealed pouches, each containing: ■ Test Device of CDV-Ab, CPV-Ab, and CAV-Ab (antibody test for Canine Distemper Virus, Canine Parvovirus, and Canine Adenovirus) ■ Desiccant pouch | 1. Immunofluorescence Analyzer (for reading test results) |
One ID Chip | 2. Timer |
Instructions for Use | 3. Pipette (already provided) |
10 tubes of CDV/CPV/CAV Ab Sample Buffer | 4. Centrifuge (not typically required for antibody tests) |
10 Pipette tips |
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 minutes.
SPECIMEN COLLECTION AND PREPARATION
The test can be performed with serum or plasma.
- Separate serum or plasma (EDTA anticoagulant is recommended) from blood within 3 hours after blood collection. If a specimen appears to be severely hemolyzed, another specimen should be obtained and tested.
- Optimally, the test should be performed immediately after the specimen collection. If the test cannot be performed within 3 hours after blood collection, store the specimen at 2 ~ 8℃ for no longer than 72 hours. 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 before testing. Specimens should not be frozen and thawed repeatedly. Only clear, non-hemolyzed specimens can be used.
TEST PROCEDURE
- Preparation:
- Set a Test Device on a clean, level horizontal table.
- Insert ID Chip into the meter, and click “Read ID chip.” Make sure the Test Device lot No. matches with ID Chip No.
- Sample Preparation:
- Pipette 20μl of prepared sample into CDV/CPV/CAV Ab Sample Buffer.
- Gently mix well. Avoid vigorous agitation and foaming.
- Run the Test:
- Choose between Standard Test (a) or Quick Test (b).
(a) Standard Test: * Pipette 100 μl of mixed sample into the sample well (S) of the CPV-Ab Test Device. * Click “Standard Test,” insert the CPV-Ab Test Device into the meter holder. * Select sample type “Serum/Plasma.” The meter will start a countdown and read the result automatically. * Repeat for CDV-Ab and CAV-Ab Test Devices, clicking “Start Test” for each after inserting them into the holder.
(b) Quick Test: * Pipette 100 μl of mixed sample into the sample well (S) of the CPV-Ab Test Device. * Click “Quick Test,” to start the timer immediately. * Leave the CPV-Ab Test Device at room temperature (18℃-28℃) for 10 minutes. * Insert the CPV-Ab Test Device into the meter holder and click “Start Test.” Select sample type “Serum/Plasma.” * Repeat for CDV-Ab and CAV-Ab Test Devices, inserting them in turn and clicking “Start Test” for each.
- Results:
- Results are displayed on the main screen.
- Print automatically or print by clicking “Print.”
QUALITY CONTROL
Each CDV/CPV/CAV Ab 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/CPV/CAV Ab in canine serum or plasma.
- Detection range:
① CPV-Ab: 4.5-640 Tu/ml
② CDV-Ab: 5.0-640 Tu/ml
③ CAV-Ab: 4.0-640 Tu/ml
- Reference range:
Result(Tu/ml) | Level | Suggestion | ||
CPV-Ab | CDV-Ab | CAV-Ab | ||
≤9 | ≤10 | ≤8 | 0 | No antibody protection, vaccination recommended. |
Result(Tu/ml) | Level | Suggestion | ||
CPV-Ab | CDV-Ab | CAV-Ab | ||
9~50 | 10~20 | 8~18 | 1 | The antibody protection is weak, so it is recommended to carry out supplementary immunization or adjust the immunization program. |
50~150 | 20~50 | 18~40 | 2 | |
150 ~ 300 | 50~100 | 40~8 | 3 | Moderate antibody protection, and strengthen antibody level monitoring, once every 6 months or so. |
300~ 500 | 100~ 200 | 80~ 160 | 4 | |
>500 | >200 | >160 | 5 | The antibody protection is strong, and the antibody level is tested every year to ensure vaccine protection in time. |
Note: The pet has not been vaccinated, but the test results show that the level is above level 1, indicating that the pet may have been infected in the past. The antibody levels of different items tested at the same time may not be consistent, because the immune response to vaccines is different for different pets. |
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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