Vetlab Supplies FASTest FIV Single Test Kit Instructions

Vetlab Supplies FASTest FIV Single Test Kit

Test-kit for the qualitative detection of antibodies against the Feline Immunodefi ciency Virus (FIV) in whole blood, plasma or serum of the cat

Supplied Exclusively To The UK Veterinary Market By
Vetlab Supplies Ltd
Visit Our Website
www.vetlabsupplies.co.uk
Telephone: 01798 874567
email us: info@vetlabsupplies.co.uk
6912 Hörbranz – AUSTRIA www.megacor.com

INFORMATION ON THE TEST-KIT

TEST-KIT COMPONENTS

1. test-kit FASTest® FIV contains:
   •  2, 10 or 25 test cassettes, coated with recombinant an-tigens
   • 1 dropper bottle A with 1.0 ml, 3.0 ml or 7.5 ml buffer diluent
   • 2, 10 or 25 disposable plastic pipettes
   • 1 instructions 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 96,4 % – Specifi city 99,2 % (Comparison Method: Westernblot)

INTRODUCTION

• The Feline Acquired Immunodefi ciency Syndrome (FAIDS), caused by the Feline Immunodefi ciency Virus (FIV), is distributed world-wide in felids. Prevalences can vary in a wide range due to keeping conditions (stray cats, day release cats) from 2–3 % in Germany up to over 30 % in Italy and 44 % in Japan.
  Infection with FIV containing body fl uids, blood or blood components normally goes parenteral (through bite injuries, blood transfusions, mating with following neck bite) as well as by transplacental and perinatal transmission into the blood of healthy cats. Free-roaming tomcats with strong territorial behavior are regarded as “risk animals” with significantly higher infection rates.

• The initial stage of infection (enlarged lymph nodes, pyrexia, neutropenia etc.) often remains unnoticed. The following lag period usually is asymptomatic over years. Only then, fi rst specifi c symptoms become apparent, predominantly caused by the diverse secondary symptoms (e. g. stomatitis, tumor diseases, anemia and leukopenia), to a lesser extent by the virus itself (e. g. neurological symptoms, lymphomas).

• Due to the more or less asymptomatic initial phase and latent period and the fact that nearly 95 % of the FIV-infected cats show high FIV antibody levels 4 weeks post-infection, the detection of FIV antibodies plays an important role as routine method of choice for the diagnosis of a potential FIV infection.
  Based on highly specifi c, recombinant FIV antigens, FASTest® FIV is an important diagnostic tool for the diagnostic evaluation of clinical as well as anamnestic FIV suspicious cats.

INFORMATION ON THE SPECIMEN MATERIAL

• 20 µl (of the attached plastic pipette) 15–25 °C warm whole blood (WB, with anticoagulant), plasma (P) or serum (S) are needed. Native blood without any anticoagulant must be avoided due to the potential risk of micro clots (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 4 days. Serum and/or plasma samples can be permanently stored at 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 exogenous interfering substances of the sample (e. g. albumin, fi brinogen, lipids, CRP, 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 infl uence the target measurement. These can lead to impaired LF and / or unspecifi c reactions on T and C.

SPECIMEN COLLECTION AND PREPARATION

• No specimen preparation necessary.
• ATTENTION: Partially filled and/or insuffi cient mixed EDTA, Citrate or Heparin tubes could create invisible mi-crosslots resulting in lateral fl ow delay and/or unspecifi c reactions (e. g. greyish shadow like lines).

TEST PROCEDURE

1. Remove the test cassette from its foil pouch shortly before use. Place it on a fl at surface.
2. Draw sample up to the mark (=^ 20 µl sample volume) using the disposable plastic pipette. Place the whole sample volume (20 µl) into the sample window S of the test cassette (hold pipette vertically, fi g.1).
3. Hold the dropper bottle A vertically and place 2 drops (ca. 80–100 µl) of the buffer diluent into the sample win-dow S of the test cassette (fi g.2).
4. Add 1 additional drop of buffer diluent into the sam-ple window S if there is no beginning LF visible within 1 minute after adding the buffer diluent.

READING OF THE TEST RESULT

Read the test result 10 minutes after the two drops have been added into the sample window S. Beyond this time, test results should not be interpreted!

POSITIVE TEST RESULT (fi g.3)
A pink-purple TEST line of any intensity (varying from very weak to strongly intensive) and a pink-purple CONTROL line appear.

NEGATIVE TEST RESULT (fi g.4)
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 (protec-tive 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 pipette and a new test cassette for each sample.
•  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® FIV is based on an immunochromatographic “sandwich principle” technique detecting anti-FIV antibodies in the whole blood, plasma or serum of the cat.
The antibodies against FIV present in the sample will react in the conjugate pad with mobile antigens conjugated to colloidal gold particles. These Ag-Ab- complexes are migrating (“lateral fl ow”, LF) along the nitrocellulose membrane and bind to membrane-fi xed recombinant FIV antigens, forming a pink-purple TEST line T.
A correct test procedure will be indicated by a second, pink-purple CONTROL line C.

• FASTest® FIV remains negative in the event of an FIV vaccination and corresponding vaccine-related antibody formation. FASTest® FIV can therefore differentiate between antibodies caused by infection (positive test) and antibodies caused by vaccination (negative test).

INFORMATION FOR THE INTERPRETATION

• 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 B and C (e. g. greyish, shadow-like lines) has to be considered as unspecific reaction and therefore as negative test result.
• Positive test results may be observed even before the end of incubation. Beyond this time, test results should not be interpreted.
• 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.
• B can vary both in intensity (from weak to strong pink-purple) and in width. Therefore, any pink-purple line which appears within the required incubation time has to be interpreted as a positive test result.
  • non-infected cat
  •  infected cat in initial phase of infection (absent titre increase Ø up to 4 weeks (ca. 95 %), but also up to 1 year post-infection)
  • cat in terminal phase (inadequate antibody production
  •  concentration below detection limit of the test).
  • FIV vaccinated cat *

FASTest® FIV = single POSITIVE

presence of FIV antibodies

• infected, viraemic cat (> 6 months)
• kitten younger than 6 months (maternal antibodies!)

References

• MEGACOR Diagnostik GmbH – Veterinary in vitro diagnostics
• Wholesale Vet Supplies & Products for Practices & Labs | Vet Supplies Online UK

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