Test kit for detection of antibodies to Ehrlichia canis

BIOPLACEFLOW EHR Ab

INTENDED USE
BIOPLACEFLOW EHR Ab is a one-step qualitative immunochromatographic assay for the
detection antibodies to Ehrlichia canis in dog’s whole blood, serum or plasma.
Assay time: 10-15 min
PRINCIPLE OF THE ASSAY
The BIOPLACEFLOW EHR Ab kit is based on sandwich lateral flow
immunochromatographic assay. The test device has a testing window for the observation
of assay running and result reading. The testing window has an invisible test (T) zone
and a control (C) zone before running the assay. When the treated sample was applied
into the sample hole on the device, the liquid will laterally flow through the surface of the
test strip and react with the pre-coated Ehrlichia canis antigen. If there are specific
antibodies to antigen in the specimen, a visible T line will appears. The C line should
always appear after a sample is applied, which indicates a valid result. By this means, the
device can accurately indicate the presence of antibodies to E.canis in the specimen.
KIT COMPONENTS
1. Test device with disposable dropper
2. Assay buffer tube
3. Product Manual
STORAGE AND STABILITY
The kit can be stored at room temperature (8-25°C). The test kit is stable through the
expiration date (12 months) marked on the package label. DO NOT FREEZE. Do not store
the test kit in direct sunlight.
TEST PROCEDURE
1. When sample and test kits are stored at cold circum stances (2-8 °C), put them at
room temperature for 15-30 minutes before use.
2. Take out a device from a pouch and place it on a horizontal surface.
3. Using a disposable pipette, add 2 drops of the test sample to the vial with the analysis
buffer, keeping the pipette strictly vertical.
4. Free the disposable pipette from the remaining sample and mix the mixture with the
pipette.

5. Add 6 drops of the diluted sample into hole (S) of the test cassette, holding the pipette
strictly vertically.
6. Read the test results between 5-10 minutes. A result obtained after 10 minutes is
invalid.

INTERPRETATION OF RESULTS
- Positive: The presence of both (C) line and 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
Test kit for detection antibodies to Ehrlichia canis BIOPLACEFLOW EHR Ab 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 PCR when positive result was observed.