MEGACOR FASTest CDV Ab Test Kit Instruction Manual

MEGACOR FASTest CDV Ab Test Kit

Test-kit for the qualitative detection of antibodies against Canine Distempervirus in whole blood, plasma or serum of the dog

INFORMATION ON THE TEST-KIT

TEST-KIT COMPONENTS

1 test-kit FASTest® CDV Ab contains:

• 2 or 10 test cassettes coated with recombinant antigens
• 2 or 10 buffer diluent tubes A with 1.0 ml buffer diluent each
• 2 or 10 disposable plastic pipettes (5 μl with mark)
• 2 or 10 disposable plastic pipettes
• 1 instructions for use

STABILITY AND STORAGE

• Store at 15–25 °C
• Expiry date – see label

APPLICATION AND ABBREVIATIONS

• For veterinary use only

• In vitro diagnosticum

• Follow instructions for use precisely

• Lot number

• Do not use test-kit components from different kits, lot numbers or beyond stated expiry date.

• T – TEST line

• C – CONTROL line

• LF – Lateral flow

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 99.9 %
• Specificity 99.8 % (Comparison Method: SN titre *)

INTRODUCTION

Antibodies (Ab) are basic modules of the humoral immune response. They are passed by passively via the colostrum as so-called maternal antibodies (mAb) onto the yet immunoincompetent newborns or induced actively by natural fi eld infection or vaccination. The ab titre is varying individually in each animal, depending on multiple factors. The titre can persist over an extended period of time, partially lifelong, in effi cient protection concentration (= reliable immunity by protective abs) or can fall below the effi cient protection concentration (nonreliable immunity) in the course of time. Depending on presence or NON-presence of abs in the sample, the veterinarian can make a quick and reliable decision regarding the necessity of “vaccination or not?” in the following questions. According to the opinion of the German Standing Vaccination Commission for Veterinary Medicine (StIKo Vet) on Ab testing*, after active immunization and / or fi eld infection (active immune response with Ab formation), every titre is protective, or “no titre” is an indication for immediate vaccination.

Testing of fi eld-infected or completely vaccinated animals
before planned routine vaccination (“titre check”)

Testing of puppies

1. to estimate the appropriate point in time for the first immunization (1st primary immunization): Screening using FASTest® CDV Ab is possible. According to the StIKo Vet statement, semi-quantitative rapid test results should be confirmed using serum neutralization test titre in order to determine the quantitative titre.
2. to determine the optimal vaccination time point of a litter, it is possible to determine the maternal ab status representatively for the other puppies (so-called “fraternal ab titre”). For this purpose, a FASTest® CDV Ab must be performed on at least two randomly selected puppies per litter.
3. to check the success of a basic immunization as early as possible from the 6th month of life.Being fast, safe and reliable, for pet owner and breeder these important questions can be answered practically by FASTest® CDV Ab. This enables the veterinarian an appropriate and customized vaccination diagnostics and strategy, adapted to dog and pet owner.

INFORMATION ON THE SPECIMEN MATERIAL

Exactly 5 μl (of attached plastic pipette with mark) 15–25 °C warm whole blood (WB, native blood with anticoagulant), 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 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 exogeneous 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 an impaired LF and / or unspecifi c reactions on T and C.

SPECIMEN COLLECTION AND PREPARATION

1. a. Draw sample up to the mark (5 μl sample volume) using the disposable 5 μl plastic pipette. The meniscus must be above the black line (fi g.1).
2. b. Open the cap of the buffer diluent tube A and mix the 5 μl of the sample by repeatedly press and release of the pipette into the buffer diluent (fi g.2). Discard the pipette.
3. c. Close the buffer diluent tube A well. Mix the sample-buffer mixture (SBM) homogeneously by careful swinging.

TEST PROCEDURE

1. Remove the test cassette from its foil pouch shortly before use. Place it on a flat surface.
2. Open the buffer diluent tube A containing the SBM. Place 4 drops (ca. 160–200 μl) of the SBM slowly into the sample window S of the test cassette using the disposable plastic pipette (without mark; hold pipette vertically, fi g.3).
3. Add 1 additional drop of SBM into the sample window S if there is no beginning pink-purple LF visible within 1 minute after adding the SBM

READING OF THE TEST RESULT

Read the test result 10 minutes after addition of the SBM into the sample window S.

POSITIVE TEST RESULT
PROTECTIVE TITRE

NEGATIVE TEST RESULT
NON-PROTECTIVE TITRE

INVALID TEST RESULT
No CONTROL line visible. The test should be repeated using a new test cassette SN titre from serum neutralisation test

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 en-sure a precise assignment.
• Use a new buffer diluent tube, new pipettes and a new test cassette for each sample.
• The FASTest® CDV Ab is not suitable for the detection of Distempervirus IgG antibodies in cats.
• ATTENTION : Partially fi lled and / or insuffi cient mixed EDTA, Citrate or Heparin tubes could create invisible mi-croclots resulting in lateral fl ow delay and / or unspecifi c reactions (e. g. greyish shadow like lines).
• 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 infec-tious and disposed of accordingly, together with the used test-kit components.

TEST PRINCIPLE

The FASTest® CDV Ab is based on an immunochromato-graphic “sandwich principle”. The anti-CDV antibodies of the sample fi rst react with the recombinant CDV antigens of the sample pad, second with the mobile monoclonal gold labeled antibodies of the con-jugate pad. During the following “lateral fl ow” (LF) along the nitrocellulose membrane, these antigen-antibody com-plexes are captured by fi xed polyclonal antibodies forming a pink-purple TEST line T. The colour intensity of T can vary depending on the anti-CDV antibody concentration of the sample. A correct test procedure will be indicated by a second, pink-purple CONTROL line (C). Evaluation of FASTest® CDV Ab is done by comparison of the colour intensities of T with C. The threshold titre (sustainable immunity or not) of FASTest® CDV Ab (1:16) is adjusted by Golden Standard Test (serum neutralisation test).

Source : https://www.openagrar.de/servlets/MCRFileNodeServlet/openagrar_derivate_00005786/Stellungnahme_Antikoerpertestung_ 2017-10-19.pdf (German)

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 T and C (e. g. greyish, shadow-like lines) has to be considered as unspecifi c reactions and therefore as negative test result.
• Due to anticoagulated whole blood and / or red hemo-globin background of the test membrane caused by hemolytic blood samples, the visibility of T, especially in case of weak positive samples, could be from worse to not visible.
• Any coloured lines appearing after 20 minutes do not have any diagnostic value.
• The FASTest® CDV Ab only detects the presence or ab-sence of anti-CDV IgG antibodies in the specimen and should not be used as the sole criterion for the diagnosis of the CDV immune status in dogs.
• Very weak positive TEST lines, caused by too small sam-ple volume (see point 4a, fi g.1) can lead to false positive test results.
• Estimation of the timing of the fi rst / second / third immu-nization for puppies: immediate vaccination is recom-mended if the test result is negative. If the result is posi-tive, it should be noted that, particularly in the case of live viral vaccines, the vaccine antigens are neutralized in the presence of high maternal Ab levels and therefore no active immunity is induced in the vaccinated individual.

Supplied Exclusively To The UK Veterinary Market By Vetlab Supplies Ltd

Visit Our Website
www.vetlabsupplies.co.uk

Telephone : 01798 874567

email us: [email protected]

Manufacturer: 6912 Hörbranz – AUSTRIA www.megacor.com

References

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

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