Anigen Rapid One-Step Canine Heartworm Antigen Test Kit

One-step Heartworm antigen Test

● Principles

The Anigen Rapid Heartworm Antigen Test Kit is an in-vitro immunochromatographic assay designed for the qualitative detection of Dirofilaria immitis antigen in canine serum, plasma, or whole blood. This test kit uses specific antibodies to selectively identify Dirofilaria immitis antigen in canine serum, plasma, or whole blood. The Anigen Rapid Heartworm Antigen Test Kit contains a membrane strip which is pre-coated with specially selected Dirofilaria immitis antibodies on the test band. During testing, the specimen is allowed to react with the colored conjugate (polyclonal Dirofilaria immitis antibody - gold conjugate) on the conjugate pad. The mixture (polyclonal Dirofilaria immitis antibody - gold conjugate - HW antigen in specimen) then moves upward on the membrane chromatographically by capillary action. For a positive result, a purple-colored band with the Dirofilaria immitis antigen in specimen - monoclonal Dirofilaria immitis antibody - colloidal gold conjugate complex will form in the test band region of the result window. Absence of this purple-colored band in the test band region suggests a negative result. Regardless of the presence of Dirofilaria immitis antigen, as the mixture continues to move across the membrane, a purple-colored band at the control band region of the result window will always appear. The presence of the purple-colored band at the control line serves as 1) verification that sufficient volume is added, 2) that proper flow is obtained, and 3) as a control for the reagents. The Anigen Rapid Heartworm Antigen Test Kit has a letter of “T” and “C” as “Test line” and “Control line” in the result window. Both the test line and control line in result window are not visible before applying any samples.

● Materials provided

● Precautions

1) For veterinary diagnostic use only.

2) For best results, strict adherence to these instructions is required.

3) All specimens should be handled as being potentially infectious.

4) Do not open or remove test devices from their individually sealed pouches until immediately before their use.

5) Do not use the test device if the pouch is damaged or the seal is broken.

6) Do not reuse test device.

7) All reagents must be at room temperature (15-30°C) before running the assay.

8) Do not use reagents beyond the stated expiration date marked on the label.

9) The components in this kit have been quality control tested as standard batch unit.

10) Do not mix components from different lot numbers.

11) The test kit should be disposed of according to local regulations for hazardous materials and in vitro diagnostics.

● Storage and Stability

The kit can be stored at room temperature or refrigerated (2-30°C). The test kit is stable through the expiration date marked on the package label. DO NOT FREEZE. Do not store the test kit in direct sunlight.

● Specimen Collection and Preparation

1) The test can be performed with serum, plasma, or whole blood (with anticoagulant such as EDTA). When using the included EDTA tubes, you should first collect the blood sample in a syringe and then put into the EDTA tube. Mix this around before using disposable dropper to draw the sample out and drop into the test device.

2) If specimens are not immediately tested, they should be refrigerated at 2-8°C. For storage more than 48 hours, freeze the specimen at -10°C or below.

*Note: Blood samples should not be frozen prior to testing.

● Procedure of the Test

1) Remove the test device from the foil pouch, and place it on a flat and dry surface.

2) Draw up the specimen using the disposable dropper.

3) Add two (2) drops (approximately 80 µl) of canine serum, plasma or whole blood into the sample hole. If the migration has not appeared after 1 minute, add one more drop into the sample well.

4) As the test begins to work, you will see a purple color move across the result window in the center of the test device.

5) Interpret test results at 5-10 minutes. Do not decide after 10 minutes.

● Interpretation of the Test

A colored band “C” will appear in the left section of the result window to show that the test is working properly. This band is the control band. The right section of the result window indicates the test results.

1) Negative Result

The presence of only one purple color band within the result window indicates a negative result.

2) Positive Result

The presence of two color bands (“T” band and “C” band) within the result window, no matter which band appears first, indicates a positive result.

3) Invalid Result

If the control purple colored band (“C”) is not visible within the result window after performing the test, the result is considered invalid. The directions may not have been followed correctly or the test may have deteriorated. It is recommended that the specimen be re-tested.

● Limitations of the Test

When using the Anigen Rapid One-Step Heartworm Antigen Test kit to detect Canine Dirofilaria immitis antigen, a low incidence of false results can occur.

clinically available tests are required if questionable results are obtained. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the veterinarian after all clinical and laboratory findings have been evaluated.

In a study conducted in the US, the kit showed a specificity of 100% (54/54) and a sensitivity of 96.4% (53/55). In samples with “2 or more female worms” recovered at necropsy, the sensitivity was 100% (41/41). In a separate multicentric field trial study conducted in the US, the sensitivity (15/15) and specificity (5/5) were found to be 100%.

● Bibliography

1) Charles H. Courtney and John A. Cornell: Evaluation of heartworm immunodiagnostic test; JAVMA 197(6), 1990, 724-729

2) Charles H. Courtney, Qi-Yun Zeng: Comparison of heartworm antigen test kit performance in dogs having low heartworm burdens; Veterinary Parasitology, 96, 2001, 317-322

3) William M. O. Boto, Kendal G. Powers and David A. Levy: Antigens of Dirofilaria immitis which are immunogenic in the canine host: detection by immune-staining of protein blots with the antibodies of occult dogs; J. Immunol., 133(2), 1984, 975-980

4) Matsumura, K., Kazuta, Y., Endo, R., Tanaka, K., Inoue, T., and Matsuda, H.: A microassay for dirofilarial antibodies by using antigen-coated nitrocellulose paper; Vet. Parasitol., 27, 1988, 337-344

5) John P. Thilsted, Jerry Whorton, Clair M. Hibbs, Gregory P. Jillson, Rick Steece and Mary Stromei: Comparison of four serotests for the detection of Dirofilaria immitis in dogs; Am. J. Vet. Res., 48(5), 1987, 837-841

6) L.C. Wang: Comparison of a whole blood agglutination test and ELISA for the detection of the antigens of Dirofilaria immitis in dogs; Ann Trop Med Parasitol, 92(1), 1998, 73-77

● Key for symbols on box

Doc. No.: I1102-7E

Issued date: Jan 19, 2023

Manufactured for Modern Veterinary Therapeutics, LLC, 15491 SW 12 Street, Bldg D, Unit 403, Sunrise, Florida 33326 USA

Tel.: +1 407 852 8039

info@modernveterinarytherapeutics.com

http://www.modernveterinarytherapeutics.com

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