Vetlab Supplies FASTest AIV Ag Test Kit Instructions

Vetlab Supplies FASTest AIV Ag Test Kit

INFORMATION ON THE TEST-KIT

TEST-KIT COMPONENTS

1. test-kit FASTest® AIV Ag contains:
   •  20 dipsticks coated with monoclonal antibodies
   • 20 sample tubes with 1.0 ml buffer diluent each
   •  20 test tubes (in racks)
   •  20 collection swabs
   •  20 disposable plastic pipettes
   • 1 instructions for use

STABILITY AND STORAGE

APPLICATION AND ABBREVIATIONS

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.

INTRODUCTION

Avian Infl uenza (Bird fl u) is a notifi able disease in birds caused by Avian Infl uenza Virus Type A (family of Ortho-myxoviridae) that infects chickens, turkeys, geese, ducks, wild water birds and other birds world-wide. Clinical symptoms are mild (decrease of egg production and / or fertility) up to highly pathogenic variants with sud-den death cases. The classical avian infl uenza, caused by the subtypes H5 and H7, is considered to be the severe form of avian infl uenza. Moreover, H5N1 is considered as elicitor of the avian infl uenza (“bird fl u”) in humans. In the classical avian infl uenza, the clinical symptoms develop suddenly and heavily (especially respiratory symptoms, bloody nasal and throat discharge as well as greenish diar-rhoea, cyanoses and oedemata in the head region and on comb and wattles, changes in colour of thighs and feed due to ecchymosis) up to sudden deaths with mortality rates up to 100 %. FASTest® AIV Ag is suitable as screening test for the fast and simple detection of all AIV type A subtypes in suspi-cious poultry stocks. It is applicable on-site. This enables the veterinarian an on-site confi rmation of the clinical suspi-cion as well as the immediate initiation of epizootic manda-tory measures to prevent a threatening pandemic.

INFORMATION ON THE SPECIMEN MATERIAL

Basically it is recommended to use single samples for test-ing. With pool samples, there is a danger that too many frenzy particles (matrix effects, unspecifi c reactions) or too few antigenic material (problem “antigenic dilution”) may be present in the sample-buffer mixture (SBM). The sample material (cloaca, trachea or kidney swab or feces) should be tested directly after sampling. Storage is possible at 2–8 °C for max. 2 d and permanently at a minimum of –20 °C. Due to the normally inhomogeneous or nest-like dissemina- tion of antigens in the sample, the specimen material has to be mixed up homogeneously (spatula, vortex-mixer) before sampling. Keep in mind that the sample material, as well as all used test-kit components, should have reached room tempera-ture at the time of application. Endogeneous and exogeneous interfering substances of the sample (e. g. proteases, mucosa components, blood, but also viscosity, pH-value as well as grass) 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 the TL and CL.

SPECIMEN COLLECTION AND PREPARATION

ATTENTION! The amount of sample material is a decisive factor, therefore, with wrong sample amount a false negative or false positive is possible.

• Introduce the collection swab into the cloaca or the feces (fi g.2) and collect as much sample as indicated in fig.1.
• Immerse the covered swab into the sample tube fi lled with 1 ml buffer diluent. Mix the SBM thoroughly until it is mixed homogeneously (fi g.3).
• Squeeze the swab against the tube wall afterwards to remove all liquid from the swab. Discard the swab properly.

TEST PROCEDURE

1. Take one test tube for each sample.
2. Draw the SBM up using the disposable plastic pipette com-pletely (without sediment!) and without air bubbles. Hold the pipette vertically and drop 10 drops (280 µl) into the sample tube (fi g.4).
3.  Remove the dipstick just now from its foil pouch and intro-duce it vertically and with the arrows pointing downwards into the sample tube. The liquid level (meniscus!) must not exceed the white arrowheads (fi g.5).
4. If the CL will not appear after 5 min- utes, a new test must be prepared.

READING OF THE TEST RESULT

Read the test result after 20 minutes. Positive test results may be observed earlier, depending on the concentration of antigen in the sample.

POSITIVE TEST RESULT (fi g.6)
A weak to strong and well-defi ned pink-purple TEST line and CONTROL line appear.
NEGATIVE TEST RESULT (fi g.7)
Only a pink-purple CONTROL line appears. This line indi-cates, irrespective of its intensity, that the test has been per-formed properly.

INVALID TEST RESULT

Only a weak to strong and well-defi ned pink-purple TEST line or no line at all appears. The test should be repeated using a new dipstick.

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 sample tube to en-sure a precise assignment.
• Use a new swab, a new and a new sample and test tube for each sample.
• The buffer diluent contains low concentrations of toxic sodium azide as a preservative, therefore avoid skin con-tact 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® AIV Ag is based on latest rapid immunochro-matographic technique. Positive samples containing Avian Infl uenzavirus Type A antigens (subtypes H1–H15) react in the conjugate pad area with mobile monoclonal anti-AIV antibodies (anti-AIV mAbs), which are bound to colloidal gold particles. Migrat-ing (“lateral fl ow”, LF) along the nitrocellulose membrane, these specifi c antigen-antibody complexes are bound by fi xed anti-AIV mAbs producing a pink-purple TEST line (TL). These anti-AIV mAbs guarantee a high level of speci-fi city for the aetiologic detection of AIV. A correct test procedure will be indicated by a second, pink-purple CONTROL line (CL).

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 TL and CL within the indicated incubation time or after more than 30 minutes (e. g. greyish, shadow-like lines) has to be considered as unspecifi c reaction and therefore as negative test result.
• TL 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.
• FASTest® AIV Ag detects all Avian Infl uenza Virus Type A subtypes regardless of their pathogenicity.
• There are no cross reactions with clinically similar infec-tious diseases (e. g. Newcastle Disease Virus (NDV), In-fectious Bronchitis Virus (IBV), Mycoplasma spp.).

PROCEDURE WITH SUSPICION ABOUT AVIAN INFLUENZA

1. Clinical-epidemiological criteria fulfi lled
2.  Suspicious case: “Avian Infl uenza“ or “Classical Bird Flu”
3. On-site testing using FASTest® AIV Ag
4. Negative FASTest® AIV Ag
5. Repetition of the test as long as the clinical suspicion persists!
6. Positive FASTest® AIV Ag
7. Suspicion on Avian Influenza substantiated
8. Report according to animal health regulations (duty of notification)

Important information

An on-site test in suspicious poultry fl ock or in suspicious wild birds in principle needs a confi rmation test prescribed by law in a national reference laboratory that is in charge for the diagnostics of Avian Infl uenza. This is valid for a nega-tive as well as a positive FASTest® AIV Ag. Due to the potential risk of RNA degradation by RNases in the sample material, a new swab of the same suspicious animal should be taken as sample material and shipped im-mediately and in accordance with the transport conditions prescribed by the reference laboratory. Further information can also be ordered at Friedrich- Loeffl er-Institut OIE und Nat. Referenzlabor für Aviäre Infl uenza Südufer 10
17493 Greifswald – Insel Riems Tel.: +49 (0) 38351 7-0 or at the related government authorities in your country.

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]

References

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

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