Vetlab Supplies FASTest D-PHYTE Strip Instructions

Vetlab Supplies FASTest D-PHYTE Strip

INFORMATION ON THE TEST-KIT

TEST-KIT COMPONENTS

1 test-kit FASTest® D-PHYTE Strip contains:

• 1, 5 or 10 dipsticks coated with monoclonal antibodies
• 1 dropper bottle A with 1.0 ml, 3.0 ml or 5.0 ml buffer diluent
• 1, 5 or 10 sample tubes with squeezer
• 1, 5 or 10 disposable plastic spatulas
• 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.

• TL – TEST line,

• CL – CONTROL line,

• LF – Lateral fl ow

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 86.7 % – Specificity 93.5 %
(Comparison Method: PCR)

INTRODUCTION

Dermatophytoses / ringworm belong to the most frequent infectious dermatoses in pocket pets, pets and farm animals, but also in humans (zoonosis).

They are caused by dermatophytes, fi lamentous fungi using keratin (skin, hair, claws and horns) as carbon source.

The clinically most relevant vet. species are Trichophyton (T. verrucosum), Nannizzia (N. gypsea [earlier Microsporum gypseum], N. persicolor [earlier Microsporum persicolor/ Epidermophyton persicolor / Trichophyton mentagrophytes]) and Microsporum (M. canis). Beside age and immunosuppression, breeding (especially persian cats) and keeping conditions (breeding, animal shelter, hunting dog, multiple species keeping), travelling, lactation (transmission of infection to puppies) as well as e. g. ectoparasite based diseases and debilitated animals play an important role in developing a ringworm disease. Warm and humid climate is an additional trigger.

The FASTest® D-PHYTE Strip guarantees a rapid clarification of the suspected clinical diagnosis and thus enables the veterinarian to quickly and reliably identify a dermatophytosis and initiate a specific therapy.

SAMPLE MATERIAL AND SAMPLING

NOT WITH COTTON SWABS!

Samples must be collected prior to a local antimycotic therapy, or a local antimycotic therapy must be suspended at least two weeks before!

• a. We strongly recommend to shorten the hair to approx. 1 cm before sampling and disinfection of the favoured sampling area with 70 % alcohol in order to largely reduce a potential saprophytic contamination (especially with molds like Aspergillus, Penicillium, Fusarium etc.)!

• b. Remove from the edge of the lesion (transition between affected and healthy skin)
  – scraping from skin (with scalpel) to get surface epithelium, dandruff and crusts and
  – pluck at least 20–30 of the shortened hair or feathers with their respective follicles (with tweezers)
  – scrape off superfi cial remains of horn from infected claws (with scalpel)
  Alternatively (latently infected animals), sample material can also be obtained using a (sterile) disposable toothbrush (MacKenzie method).

• c. The sample material (also from spaces between the toothbrush) must be thoroughly homogenised using tweezers, scalpel and / or the enclosed disposable spatula or scissors (hair shredding, if not shortened to 1 cm, –
  3.a) before use. Attention: Dispose of laboratory equipment after each sample or disinfect it thoroughly!

All test kit components and sample material should have room temperature (15–25 °C) at the time of application.

The sample stored at room temperature (15– 25 °C) should be tested immediately or at least on the same day! The samples can be stored at 2–8 °C up to max. 14 days.

SAMPLE PREPARATION

1.  Open the sample tube and place the pea-sized sample (ø min 5, max 8 mm) in the middle of the sample tube (fig.1).

2. Destroy the sample by closing the blue cap with the attached squeezer tightly into the sample tube (fig.2).

3. Open the sample tube again. Hold the dropper bottle A vertically and add minimum 5 (250 µl) up to maximum 10 (500 µl) drops of buffer diluent. In case of any sample remains on the squeezer, let the 5 drops flow over the squeezer into the sample tube (fig.3).
   

4. Mix the squeezed sample material homogeneously with the buffer diluent by twisting and untwisting the blue cap for several times (see fig.2).

5. If sample material (especially hair) sticks to the squeezer or the sample tube wall, take the plastic spatula and slide the material into the sample buffer mixture (SBM).

6. For pre-incubation of the sample material in the SBM, place the sample tube on a flat and horizontal surface for 2 minutes (fig.4).

TEST PROCEDURE

1. Remove the dipstick from its foil pouch shortly before use.
2. Introduce the dipstick vertically and with the arrows pointing downwards into the sample tube for at least 1 minute (fig.5).

The liquid level must not exceed the blue plastic cover with the white arrows (fig.6).

3. Remove the dipstick from sample tube soonest the SBM has reached the CONTROL line (CL). If so, the pink CL will appear slowly but surely. If the CL will not appear after 5–10 minutes, a new SBM must be prepared and sedimented for at least 5 minutes. The dipstick must be held in the supernatant until the LF has reached the CL.
4. Place the dipstick on a flat and horizontal surface (fig.7).

READING OF THE TEST RESULT

Read the test result within the incubation time of 5–30 minutes.

POSITIVE TEST RESULT (fig.8)
A pink-purple TEST line of any intensity (varying from very weak to strongly intensive) and a pink CONTROL line appear.

NEGATIVE TEST RESULT (fig.9)
Only a pink 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 dipstick.

PRECAUTIONS FOR USERS

• Basically: Take personal protective measures, e. g. gloves, protective clothing, possibly a face mask (aerosols – zoonotic pathogens)!
• Label sample material and associated dipstick to ensure a precise assignment.
• Use a new sample tube, a new spatula and a new dipstick 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 for humans and disposed of accordingly, together with the used test-kit components.

TEST PRINCIPLE

The FASTest® D-PHYTE Strip is based on an immunochromatographic “sandwich principle”.

The dermatophyte antigens present in the sample will react at the conjugate pad with mobile antibodies, which are conjugated to colloidal gold particles. These antigenantibody complexes are migrating along the nitrocellulose membrane (“lateral fl ow”, LF) and are bound by fi xed antibodies against dermatophytes for ming a pink-purple TEST line (TL). The intensity or width of the TL depends on the concentration of dermatophyte antigen in the introduced amount of sample.
A correct test procedure will be indicated by a second pink CONTROL line (CL).

INFORMATION FOR THE INTERPRETATION

• The interpretation of the test result should always be based on anamnestic and clinical data (blotchy alopecia on the face, ears, forelimbs. There is usually no itching!
  Exception adult cats with moderate to intense itching!) as well as the therapy and prophylaxis possibilities.

Unspecific reaction (TL and / or CL)

Any non-described colour or contour variation (e. g. greyish, shadow-like lines) has to be considered as unspecific reaction and therefore as negative test result.

Positive test result

• depending on the antigen concentration (high), a TL may already appear during LF. The result can be already read after 5 minutes
• the animal must be seen as potentially zoonotic for humans, especially for children.
• If confirmatory testing or dermatophyte species differentiation by PCR is required, we recommend sending it to a specialised veterinary laboratory!
• ATTENTION: Homogenisation of original sample is an indispensable criterion before testing with FASTest® D-PHYTE Strip and before partial sampling for sending to the veterinary laboratory! If this is not guaranteed, statistically it is not the same original sample!

Negative test result

may be due to despite a suspected clinical diagnosis

• sampling in the wrong place
• too little and / or inadequate material
• no homogenisation before testing
• too little sample quantity for testing
  • take another sample at a different suspicious location and homogenise the sample well and use sufficient sample material for the test!

Customer Service

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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