Vetlab Supplies FASTest CRP Canine Test Kit Instructions

: June 9, 2024
: Vetlab Supplies

Table of Contents

Vetlab Supplies FASTest CRP Canine Test Kit
INFORMATION ON THE TEST-KIT
- LIABILITY
INTRODUCTION
- INFORMATION ON THE SPECIMEN MATERIAL
SPECIMEN PREPARATION
TEST PROCEDURE
READING OF THE TEST RESULT
PRECAUTIONS FOR USERS
TEST PRINCIPLE
INFORMATION FOR THE INTERPRETATION
- INSTRUCTIONS FOR USE
Documents / Resources

Vetlab Supplies FASTest CRP Canine Test Kit

Vetlab-Supplies-FASTest-CRP-Canine-Test-Kit-PRODUCT

INFORMATION ON THE TEST-KIT

TEST-KIT COMPONENTS

1 test-kit FASTest® CRP canine contains:
2, 10, or 25 test cassettes coated with monoclonal antibodies
2, 10, or 25 dropper bottles A with 2.0 ml buffer diluent each
2, 10 or 25 disposable plastic pipettes (5 µl)
2, 10 or 25 disposable plastic pipettes (10 µl)
1 instruction for use

LIABILITY

The entire risk due to the performance of this product is assumed by the purchaser. The manufacturer shall not be liable for indirect, special or consequential damages of any kind resulting from the use of this product.

ACCURACY

Sensitivity 96 % – Specificity 81 % (Plasma/serum
Sensitivity 95 % – Specificity 94 % (Whole blood)
(Comparison Method: ELISA

INTRODUCTION

In response to tissue injury and inflammation, the body produces, among others, so-called acute-phase proteins (APP) in the liver. The C-reactive protein (CRP) is the most sensitive and fastest acute-phase protein of the dog, with low serum concentrations during normal homeostasis and a quick answer during and after inflammation. The function of CRP is, among others, the stimulation of the unspecific immune defence by activation of scavenger cells and the complement cascade.
The measurement of CRP in dogs is useful for the diagnostics and follow-up of inflammatory diseases. In healthy dogs, there is a low CRP level below 10 mg / l. A drastic increase in the CRP level occurs in inflammatory processes within a few hours (Ø 24–28 h by a factor of 10 to 100) due to infections, immune disorders, neoplasia, and traumata.
As soon as the inflammation subsides through a successful therapy, the CRP level decreases rapidly within Ø 24–28 h.
Therefore CRP can be regarded as a real-time marker. Indicating inflammations, CRP is more sensitive than the determination of rectal temperature or leucocyte differential diagnostics. Another advantage of CRP determination is its independence from endogenous or iatrogenic disturbing factors (e. g. glucocorticoids, stress).
FASTest® CRP canine is a lateral flow immunoassay using highly specific monoclonal antibodies against dog CRP. It can be used with whole blood, plasma or serum of dogs for in-clinic and/or laboratory testing.
With the help of FASTest® CRP canine, the veterinarian is enabled to prove (positive FASTest® CRP canine: CRP 10 mg / l) or rule out (negative FASTest® CRP canine: CRP < 10 mg / l) the suspicion of an inflammatory event on-site and without technical equipment.

INFORMATION ON THE SPECIMEN MATERIAL

10 µl (of the attached plastic pipette) 15–25 °C warm whole blood (WB, with anticoagulant) or 5 µl plasma (P) or serum (S) are needed. Native blood without anticoagulant should not be used due to potential micro agglutination (e. g. migration delay on the membrane, unspecifi c reaction)!
Mix the sample material well before use!
Non-cooled (15–25 °C), WB, P and S should be tested within 4 hours! At 2–8 °C, WB, P and S can be stored up to 48 hours. Serum and / or plasma samples can be permanently stored at a minimum −20 °C.
Keep in mind that the sample material, as well as all used test-kit components, should have reached room temperature at the time of application.
Endogeneous and exogeneous interfering substances of the sample (e. g. albumin, fi brinogen, lipids, heterophilic antibodies, especially type IgA, as well as viscosity, pH-value, and excess EDTA), as well as native blood, can cause interferences (matrix effects) that can influence the target measurement. These can lead to impaired LF and/or unspecific reactions on T and C.

SPECIMEN PREPARATION

No specimen preparation is necessary.
ATTENTION: Partially filled and / or insufficient mixed EDTA, Citrate or Heparin tubes could create invisible micro clots resulting in lateral flow delay and / or unspecific reactions (e. g. greyish shadow-like lines)

TEST PROCEDURE

Remove the test cassette from its foil pouch shortly before use. Place it on a fl at surface. Adjust the stop watch to an incubation time of 5 minutes!
2a. Plasma or serum: 5 µl sample volume Draw sample up to the mark (=^ 5 µl sample volume) using the disposable long plastic pipette. Place the whole sample volume (5 µl) into the dropper bottle A (hold pipette vertically, fi g.1a).
2b. EDTA / heparin whole blood: 10 µl sample volume Draw sample up to the mark (=^ 10 µl sample volume) using the disposable short plastic pipette. Place the whole sample volume (10 µl) into the dropper bottle A (hold pipette vertically, fi g.1b). 2c. Mix the sample-buffer mixture (SBM) thoroughly (fi g.2).
Break the tip of the dropper bottle A, hold the dropper bottle A vertically and add 3 drops (100 µl) SBM into the sample window A of the test cassette (fi g.3).
Start the stopwatch that is adjusted to 5 minutes.

READING OF THE TEST RESULT

Read the test result after an incubation time of EXACTLY 5 minutes. After this time, the test result can no longer be interpreted.

POSITIVE TEST RESULT (fi g.4)

A pink-purple TESTline of any intensity (varying from very weak to strongly intensive) and a pink-purple CONTROL line appear.

NEGATIVE TEST RESULT (fi g.5)

Only a pink-purple CONTROL line appears. This line indicates, irrespective of its intensity, that the test has been performed properly.

INVALID TEST RESULT

No CONTROL line visible. The test should be repeated using a new test cassette.

PRECAUTIONS FOR USERS

The guidelines for working in medical laboratories must be observed. It is recommended to wear disposable gloves and other personal protective equipment (protective clothing, possibly a face mask). Wash and disinfect hands after completing the test.
Label sample material and associated test cassette to ensure a precise assignment.
Use a new plastic pipette and a new test cassette for each sample.
Take the required sample volume (10 µl anticoagulated whole blood or 5 µl plasma or serum) only with the attached plastic pipettes or with a calibrated laboratory pipette.
The buffer diluent contains low concentrations of toxic sodium azide as a preservative, therefore avoid skin / eye contact and / or ingestion.
The sample material must be seen as potentially infectious and disposed of accordingly, together with the used test-kit components.

TEST PRINCIPLE

The FASTest® CRP canine is based on an immunochromatographic “sandwich principle”.
CRP molecules in the sample will bind in the conjugate pad with highly specifi c mobile monoclonal antibodies against
CRP, which are conjugated to colloidal gold particles. These antigen-antibody complexes complexes are migrating (“lateral fl ow”, LF) along the nitrocellulose membrane and bind to fi xed monoclonal anti-CRP antibodies forming a pinkpurple TEST line (T).
A correct test procedure will be indicated by a second pinkpurple CONTROL line (C).
The intensity of the TEST line will increase during incubation time and is directly proportional to the CRP concentration of the sample.

INFORMATION FOR THE INTERPRETATION

Negative: < 10 mg / l Cut-off Positive: 10 mg / l

The incubation time or reading time of exactly 5 minutes is essential!

The interpretation of the test result should always be based on anamnestic and clinical data as well as the therapy and prophylaxis possibilities.
Any non-described colour or contour variation of T and C (e. g. greyish, shadow-like lines) has to be considered as unspecifi c reaction and therefore as negative test result.
Due to anticoagulated whole blood and / or red hemoglobin background of the test membrane, caused by hemolytic blood samples, the visibility of B, especially in case of weak positive samples, could be from worse to not visible.
Wrong handling or wrong interpretation of the test could have a negative effect on the signifi cance of the test and / or make the results inconclusive.