tamaVet 1172043N-05, 1172643N-01 Giardia Test Instruction Manual

tamaVet®
Giardia Test (test cassette)
REF. 1172043N-05 / REF. 1172643N-01

Intended Use

The tamaVet® Giardia Test is for use in the detection of specific antigens of Giardia lamblia (syn. intestinalis/ duodenalis) in dog or cat faeces. The test is intended for use as an aid in the diagnosis of giardiasis.

 Introduction and Clinical Significance

Giardia is a genus of microscopic small intestinal parasites and is among the most widespread intestinal parasites globally.
Giardiasis is a mostly mild running disorder of the gastrointestinal tract. Infected animals suffer from diarrhoea and following this, weight loss. Older animals tend to acquire  immunity against Giardia, whilst younger animals seem to be more affected and show clinical signs.
A high-carbohydrate diet and gastrointestinal disorders are among the predisposing factors for the onset of a clinically manifest giardiasis. In untreated animals, the course of
disease varies from one week to several months.
Giardiasis is diagnosed by the detection of versatile Giardia trophozoites or cysts in fresh faeces. Considering that the excretion of Giardia trophozoites and cysts is irregular  and can also stop intermittently, repeated testing is recommended. At least three examinations of faecal samples over a period of about seven to ten days should be carried out  before giardiasis may be excluded or diagnosed.

 Test Principle

The tamaVet® Giardia Test is a sandwich immunoassay. The assay employs specific antibodies which capture Giardia antigens from the sample and thus visualize the agent. The tamaVet® Giardia Test is a highly sensitive immunoassay and comprises a test strip housed in a handy test cassette.
The tamaVet® Giardia Test strip consists of a sample pad, a conjugate pad, a reaction membrane and an absorption pad. The conjugate pad contains specific latex-labeled anti-Giardia antibodies. The reaction membrane is precoated with second Giardia specific capture antibodies immobilised in the test line region and as a control, antibodies immobilised in the control line region. The absorption pad is at the end of the test strip.
After application of the specimen onto the test strip Giardia antigens in the sample material react with the latex-labeled antibodies to form a complex in the conjugate pad. The fluid then migrates along the strip by capillary action. In the test line region, the formed complexes are captured by the immobilised capture reagent, causing the formation of a blue line. The presence of a blue line in the test line region indicates a positive result. If the sample does not contain Giardia antigens, no line will form in the test line region. Additionally, a blue line must form in the control line region, irrespective of the presence of Giardia antigens in the specimen. The control line serves as an internal control and indicates that sufficient sample fluid has been applied to the test strip and that proper membrane wicking has occurred.

4.1. Reagents and Materials Supplied (REF. 1172043N-05)

• 5 tamaVet® Giardia Test cassettes
• 5 sample tubes with 1mL buffer solution
• 5 cotton swabs
• 1 package insert

4.1. Reagents and Materials Supplied (REF. 1172043N-05)

•  5 tamaVet® Giardia Test cassettes
• 5 sample tubes with 1mL buffer solution
• 5 cotton swabs
• 1 package insert

Additional Materials Required

Timer

Storage & Stability

The tamaVet® Giardia Tests must be stored at room temperature (15-30°C). The test is stable until the expiration date printed on the foil pouch. The test cassette should  remain in the sealed foil pouch until use. Do not freeze tests.

Warnings and Precautions

• For veterinary use only.
• For single use only.
• Store tests between 15-30°C. Do not to freeze tests.
• Do not use tests beyond the expiry date.
•  Do not use tests with damaged pouches.
• Perform the test within 60 minutes of removing the test cassette from the pouch.
• Consider the test results as invalid after more than 10 minutes.
• Please use the stated amount of sample. An incorrect number of drops can lead to a false result.
• Place the test cassette on a smooth, flat surface whilst performing the test.
• Do not touch the reaction field.
• Use only the test components included in the kit. Do not mix or replace the test components with components from a different kit.
• Avoid cross contaminations by using a new sample tube and a new swab for each sample.
• Sample materials are potentially infectious. During the test procedure, adhere to standard guide lines for the handling of potentially infectious material and chemical reagents.
  The use of protective clothing (laboratory coat, gloves, eye protection) is recommended. Materials that have come into contact with the sample material should be  disposed of in accordance with local regulations.

Specimen Collection and Preparation

The tamaVet® Giardia Test was developed for the examination of fresh dog or cat faeces.
General comments:

• Pooled feaces samples are also suitable for testing.
• If testing is not to be carried out on the day of sample collection, the faecal sample can be stored for a maximum of 6 days at 2°C to 8°C.
• The faecal sample must be brought to room temperature (15-30°C) before performing the test.
• As the cysts are spread irregularly in the faeces, use the swab to stir the faecal sample well.
• Avoid picking up cat litter or other coarse particles during sample collection.
• Use the cotton swab to take up feacal material. It is sufficient when the cotton tip of the swab is covered with faeces.

Test Procedure

1. Specimen and kit components should be brought to room temperature before performing the test.
2. Open the aluminium pouch of the test cassette and place the cassette on a horizontal surface.
3. Open the sample tube and put the cotton swab with the faecal sample into the sample tube, containing the reagent. Stir the fluid well with the cotton swab so that the sample material dissolves. For an optimal test result it is recommended to wring the swab into the sample tube by squeezing the tube with the swab in the middle a couple of times to dissolve the sample. As a control, you should see the reagent discolor.
4. Remove the swab and close the sample tube. Shake the sample tube well, so that the reagent can react with the sample. Break off the tip of the sample tube by pressing it firmly.
5. Holding the tube vertically with the lid closed, dispense 3 drops of sample solution into the sample well of the test cassette. Start the timer. If the liquid does not migrate sufficiently along the test strip after a few seconds, add another drop to the sample well until the liquid starts running. If too much faeces is in the sample well you can also touch the tip of the cotton swab into the sample well to reactivate the test run.
6. Read the results 10 minutes after starting the timer. Do not interpret the result after more than 10 minutes. The test and the result are considered as invalid after this period.

 Result Interpretation

Positive result
The test is positive when a blue control line (C) and a blue test line (T) are visible in the reaction area. Giardia antigens have been detected in the sample material. If a weakly  defined test line appears, the test result is nevertheless positive.

Negative result
The test is negative when only a blue control line (C) is visible in the reaction area. No Giardia antigens have been detected in the sample material.

Invalid result
If no control line is visible after the test was performed, the test is invalid. All results, that show no control line after the denoted time, must be rejected. Review the test procedure and repeat the test with a new test cassette. If problems continue, discontinue using the test kit and contact your distributor.

Quality Control

Several internal controls are included in the test cassette:
A blue line forming in the control line region (C) is considered an internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking and  correct procedural technique. In addition, there is a green line in the control line region and in the test line region before starting the test. The lines are considered as a quality control method and will be washed away by the sample liquid during the test.

Limitations

• Test results must alway be interpreted in the light of all the medical findings and never individually. All test results, which do not correlate with the clinical picture, must be repeated. Positive results detected with the tamaVet® veterinary rapid tests must be approved with another analytical method.
• There is a possibility that the test result is distorted by technical errors, errors in the experiment or by substances or factors that influence the test and have not been mentioned here.

Performance Characteristics

Sensitivity: 91.9%
Specificity: 97.9%
Overall agreement: 95.2%
Comparison method: ELISA 2016/2017

References

1. Krankheiten der Katze (Hrsg.: M. Chr. Horzinek, Vera Schmidt, Hans Lutz)  Enke, 4. Auflage, 2005, S. 199 – 200
2. Innere Medizin der Kleintiere (von Richard W. Nelson – C. Guillermo Couto) Elsevier, 2006, S. 47

Rev. 3, 2019-12-18 HM/MKa

Symbol|
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| CE marking of conformity
| Consult instructions for use
| in-vitro diagnostic medical device
| Temperature limitation
| Batch code
| Do not reuse
| Use by
| Catalogue Number
| Manufacturer
| Sufficient for tests

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References

• nal von minden GmbH - Spezialist für hochwertige in-vitro Diagnostik
• nal von minden GmbH - Spezialist für hochwertige in-vitro Diagnostik
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