Ehrlichia-Babesia gibsoni- Anaplasma Antibody Combo Test

• INTENDED USE

The Ehrlichia – Babesia gibsoni - Anaplasma Antibody Combo Test is a test cassette to diagnose the presence of antibodies against Ehrlichia canis, Ehrlichia ewingii, Babesia gibsoni, Anaplasma phagocytophilum and Anaplasma platys in dog’s blood specimen.

Assay Time:  5-10 minutes

Specimen: Serum, plasma or whole blood

• PRINCIPLE

The Ehrlichia – Babesia gibsoni - Anaplasma Antibody Combo Test is based on sandwich lateral flow immunochromatographic assay.

• REAGENTS AND MATERIALS
• Test devices
• Assay buffers
• Disposable capillary droppers
• Products Manual
• STORAGEAND STABILITY

The kit can be stored at room temperature (4-30°C). The test kit is stable through the expiration date (24 months) marked on the package label. DO NOT FREEZE. Do not store the test kit in direct sunlight.

• SPECIMEN PREPARATION AND STORAGE
• Specimen should be obtained and treated as below.
• Serum or plasma: collect the whole blood for the patient dog, centrifuge it to get the serum, or place the whole blood into a tube which contains anticoagulants to get plasma.
• Whole blood: collect fresh blood for use directly or make anticoagulant blood for storage at 2-8℃.
• All specimen should be tested immediately. If not for testing right now, they should be stored at 2-8℃.
• TEST PROCEDURE
• Allow all materials, including specimen and test device, recover to 15-25℃ before running the assay.
• Take out the test card from the foil pouch and place it horizontally.

Use the capillary dropper to place 1 drop (approx.10μL) of the prepared specimen into each sample hole “S” of the test card. Then drop 3 drops (approx. 90μL) of the assay buffer into each sample hole. Start the timer.

• Interpret the result in 5-10 Result after 10 minutes is considered as invalid.
• 
• • INTERPRETATION OF RESULTS
  • Positive (+): The presence of both “C” lineand zone “T” line, no matter T line is clear or vague.
  • Negative (-): Only clear C line appear. No T line.
  • Invalid: No colored line appears in C zone. No matter if T line appears.
  • PRECAUTIONS
  • All reagents must be at room temperature before running the assay.
  • Do not remove test cassette from its pouch until immediately before use.
  • Do not use the test beyond its expiration date.
  • The components in this kit have been quality control tested as standard batch unit. Do not mix components from different lot numbers.
  • All specimens are of potential infection. It must be strictly treated according to the rules and regulations by local states.
  • LIMITATION

  The Ehrlichia – Babesia gibsoni - Anaplasma Antibody Combo Test is for in vitro veterinary diagnosis use only. All result should be considered with other clinical information available with veterinarian. It is suggested to apply a further confirmative method such as microscopy when positive result was observed.