Rapid Test CPV+CCV (V-Diag)

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Rapid Test CPV+CCV ชุดตรวจโรคลำใส้อักเสบในสุนัข

Evaluation report of V-Diag CPV/CCV Antigen Test
1. Product name: V-Diag CPV/CCV Antigen Test (Code: VET-06-010B)
A rapid one step test for the qualitative detection of canine parvovirus and canine coronavirus antigen in
feces or vomit sample.
2. Type of Assay:
V-Diag CPV/CCV Antigen Test is a sandwich lateral flow immunochromatographic assay for the
qualitative detection of canine parvovirus (CPV Ag) and canine coronavirus (CCV Ag) in dog’s feces or
vomit.
3. Type of specimen:
Feces or vomit
4. Manufacturer:
Pacific Biotech Co., Ltd
5. Evaluation site :
BRIA Lab Co., Ltd

6. Principle of thetest:
V-Diag CPV/CCV Antigen Test is based on sandwich lateral flow immunochromatographic assay. The
test device has two testing windows. The testing windows have been coated with invisible control band
and test band specific for each antigen test. And surface of testing window also have letter printed as
“CON” for control band, “CPV” for canine parvovirus antigen test band and “CCV” for canine coronavirus
antigen test. When sample is applied into the sample hole on the device, the liquid will laterally flow on
the surface of the test strip. If there is enough parvovirus and/or coronavirus antigen in the sample, a
visible CPV and/or CCV band will appear. The “Con” bands should always appear after a sample is applied,
indicating a valid result. By this mean, the device can accurately indicate in the presence of canine
parvovirus antigen and/or canine coronavirus antigen in sample.
6.1 Test Procedure:
6.1.1. Collect dog’s feces or vomit with the swab stick from dog’s cloaca or on the ground.
6.1.2 Insert the wet swab into the provided assay buffer tube. Agitate it to assure good sample
extraction. Wait until the large particles have settled down to the bottom of the tube.
6.1.3 Take out the cassette from the foil pouch and place it horizontally.
6.1.4 Using the disposable dropper provide, dispense 2 drops of the supernatant from extracted sample
in to each sample well “S” of the testing device both left and right.

Reference tests
Data obtained by the V-Diag CPV/CCV Antigen Test were comparing to some veterinarian’s clinical signs
and a leading commercial parvovirus antigen rapid test kit ; AnigenTM CPV/CCV Antigen Rapid Test.
8. Evaluation of the V-Diag CPV/CCV Antigen Test
8.1 Instruction
8.1.1 Storage condition:
The kit can be stored at room temperature (2-30˚C) .DO NOT FREEZE. Do not store the test kit in
direct sunlight.
8.1.2 Stability:
The test kit is stable through the expiration date (18 months) marked on the package label.
8.1.3 Reading test results:
Interpret test result at 10 minutes
8.1.4 Interpretation of results:
Negative: A colored line in the control line region (Con) but no line in the test
line region (CPV and/or CCV) for a specific antigen indicates a
negative result.
Positive: A colored line in the control line region (Con) and a colored line in
the test region for a specific antigen (CPV and/or CCV) indicate a
positive result.
Invalid : Control line fails to appear. Insufficient specimen volume or incorrect
procedural techniques are the most likely reasons for control line
failure. Review the procedure and repeat the test using a new test
device. If the problem persist, discontinue using the lot immediately
and contact your local distributor.
8.1.5 Work procedure, preparation ofreagents:
The package insert is clearly described.
8.2 Presentation
8.2.1 Contents
The test kit are contains
– 10 V-Diag CPV/CCV Antigen Test device
– 10 Specimen tube containing assay diluents
– 10 sample collection swabs
– 10 Disposable dropper
– 1 Instruction for use
8.2.2 Labels
Lot number and expiry dates are marked on the labels of box and pouch.
8.2.3 Test Kit information
Lot number: 10213
Manufacturing date: October 2010
Expiration date: April 2012
Pacific Biotech Co., Ltd Evaluationreport
page 3 of 3
9. Analysis of theresults
9.1. Sensitivity (%) = 100 x
9.2 Specificity (%) = 100 x
10. Result:
# of feces/vomit samples with positive results
# of positive feces/vomit samples tested
# of feces/vomit samples with negative results
# of negative feces/vomit samples tested
Using a panel of clinical positive and negative dog’s sample collected from several pet hospitals, a
comparative study between AnigenTM CPV/CCV Rapid Test and V-Diag CPV/CCV Antigen Test was
performed. The AnigenTM CPV/CCV Rapid Test was used a reference test.
10.1. Sensitivity and specificity of V-Diag CPV antigen test strip

The agreement of V-Diag CPV/CCV Antigen Test with clinical samples was equal to 97.56% (80/82).
10.2 Sensitivity and specificity of V-Diag CCV antigen test strip

The agreement of V-Diag CPV/CCV Antigen Test with clinical samples was equal to 98.00% (49/50).
11. Conclusion
The V-Diag CPV/CCV Antigen Test shows a good specificity and a very high sensitivity, detecting only 2
false negative among 47 CPV antigen positive samples and only 1 false negative among 15 CCV antigen
positive samples.
Compared with the well-known brand AnigenTM CPV/CCV Rapid Test, Ve-Diag CPV/CCV Antigen Test

ค่า Sensitivity และ specificity