Vetlab Supplies FASTest CHLAM Ag Test Kit Instructions

Vetlab Supplies FASTest CHLAM Ag Test Kit

INFORMATION ON THE TEST-KIT

TEST-KIT COMPONENTS
1 test-kit FASTest® CHLAM Ag contains:

• 2 or 10 test cassettes, coated with mono- and polyclonal antibodies against Chlamydia spp.
• 1 dropper bottle A with 2.0 ml or 10.0 ml buffer diluent
• 2 or 10 sample tubes (working station rack) with special fi lter cap
• 2 or 10 specimen collection swabs
• 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 93 % – Specifi city 99.5 %
(Comparison Method: Cell Culture)

INTRODUCTION

Chlamydia are obligate intracellular bacteria in animals (low host specifi city) and humans (high host specifi city) world-wide. Chlamydia with zoonotic potential are C. psittaci, C. abortus, C. trachomatis and C. pneumoniae. Depending on country and species, chlamydiosis is a notifi able or reportable disease!
In the cat, esp. in kittens, C. felis has an important role in the cat fl u complex. Infection normally occurs via direct contact / droplet infection. Unilateral, some-times bilateral serous-purulent conjunctivitis with a strong chemosis are typical. In principle, all cats of a population should be tested and positive cases treated (ABCD guidelines) and vaccinated after the clinical symptoms have disappeared (non-core vaccination). Untested and untreated animals can develop a carrier sta-tus with possible recurrences.
In the bird (C. psittaci: psittacosis of psittacids; ornithosis of poultry and wild birds), infection occurs especially via feces, nasal discharge, droplet infection and contaminated dust. The clinical symptoms vary from ruffl ed feathers, emacia-tion, conjunctivitis, infl ammation of the upper respiratory tract with eye and nasal discharge to light green coloured feces and diarrhoea with death in some cases. Latent infected psittacids are a considerable pathogen source for other birds and humans.
In ruminants (cattle, sheep, goat; esp. C. abortus, C. pecorum, C. psittaci) infec-tions often are subclinical. High abortion rates (in small ruminants mainly during second half of gestation), perinatal calf losses, subclinical mastitis as well as joint, hoof and limb diseases are a hint onto a population problem with chlamydia. In horses, C. abortus, C. pneumoniae were proven in conjunction with pneu-monia, rhinitis, keratoconjunctivitis, abortion etc., but also in clinically healthy horses. Transmission is oral, aerogen, via mucosa, wounds or via mating as well as via nasal and bronchial discharge, abortion, sperm or urine.
The dog (C. caviae, C. felis, C. psittaci, C. pneumoniae, C. trachomatis) gets in-fected via direct contact, droplet infection, uptake of bird feces or infected dead birds. Clinical symptoms (fever up to 42 °C, bronchopneumonia, cough, kerato-conjunctivitis, inappetence, diarrhoea, vomitus or tonic-clonic attacks) are diverse and therefore often not associated with Chlamydia.
Due to the highly infectious and zoonotic potential of Chlamydia spp. and the vague prevalence of some species, animals suspicious for chlamydiosis should be tested via FASTest® CHLAM Ag. Animals, especially dogs, with unclear clinic (exclusion diagnostics) should also be tested.
The FASTest® CHLAM Ag gives a fast aetiological diagnosis of a Chlamydia spp. infection. Especially due to the often unclear symptoms and the high infective-ness for animal and human, an on-site test is necessary. As a consequence, appropriate treatment, vaccination and quarantine measures can be initiated immediately.

INFORMATION ON THE SPECIMEN MATERIAL

FASTest® CHLAM Ag is designed for testing a variety of secre-tions, excretions, feces and organs of animals. Sampling should be done only with the special rayon / dacron tipped swabs provided. Do not use wooden-shafted, cotton or calcium alginated-tipped swabs for sampling, because these are toxic for Chlamydia spp.!
Due to the fact that FASTest® CHLAM Ag needs no viable Chlamydia spp. antigens, swab samples can be stored dry in their original wrapping material refrigerated at 4–8 °C up to 3 days or at −20 °C up to 2 weeks. Do not place swab in transport medium as this may interfere with the test.
Excess mucus, pus or blood in the sample material will inter-fere with lateral fl ow process and could lead to false positive test results. Therefore any excess mucus, pus or blood should be removed before using the provided swab for sampling.
Cervix and / or tissue extracts (cattle, sheep, goat): Remove any excess mucus, pus or blood. Rotate the swab for 30 sec-onds in the endocervical area to collect epithelial cells. For ex-tract sampling roll the swab directly on the surface of placental tissues.
Conjunctiva (dog, cat): Remove any excess mucus, pus or blood. Rotate the swab for 30 seconds on the lower conjunctival membrane to collect conjunctival cells. Each eye must be tested separately (1 swab per test!)
Throat (horse): Remove any excess mucus, pus or blood. Rotate the swab for 30 seconds in the throat to collect epithelial cells.
Cloaca (birds): Remove any excess mucus, pus or blood. Rotate the swab for 30 seconds in the cloaca to collect epithelial cells.
Droppings (birds): Push the swab 3 times into the dropping at 3 different locations.
Organs (birds): Roll the swab directly on the surface of organs e. g. liver, lung cell material.

SPECIMEN PREPARATION

• a. Fill the sample tube (working rack) with 22 drops (0.9 ml) of buffer diluent of the dropper bottle A (fi g.1).
• b. Dip the well-coated swab into the sample tube. Mix the swab until the sample has been dissolved into the buffer diluent, at least for 10 seconds. Leave the swab in the sample tube (fi g.2).
• c. Extraction: Incubate the sample tube with the swab for 10–15 minutes at room temperature. Swirl the swab 2–3 × for some seconds against the tube wall.
• d. Squeeze the swab after incubation time against the tube wall to remove all liquid from the swab. Discard the swab.
• e. Put the special fi lter cap on, press shut (fi g.3). The swab extract can remain in the sample tube at room temperature for up to 30 minutes without affecting the test result

TEST PROCEDURE

1. Remove the test cassette from its foil pouch shortly before use. Place it on a flat surface.
2. Drop carefully (allow each drop to absorb before adding the next one) 4 drops (approx. 150 μl) of swab extract to the sample window A of the test cassette (fi g.4). Avoid bubbles!
3. Add 1 additional drop of swab extract into the sample window A if there is no beginning LF visible within 1 minute after adding the swab extract.

READING OF THE TEST RESULT

Read the test result 20 minutes after the swab extract has been added into the sample window A.

POSITIVE TEST RESULT (fi g.5)
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.6)
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 mustbe 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 sample tube, a new swab and a new test cassette for each sample.
• The buffer diluent contains low concentrations of toxic sodium azide as a preservative, therefore avoid eye / skin contact and / or ingestion.
• The sample material must be seen as potentially infectious, due to the zoonotic potential of Chlamydia spp. It must be disposed of accordingly, together with the used test-kit components.

TEST PRINCIPLE

The FASTest® CHLAM Ag is based on an immunochromatographic “sandwich principle” for the qualitative detection of genus-specifi c lipopolysaccharide (LPS) antigens of Chlamydia in different exudates, extracts of organs and feces of animals.
Genus-specifi c LPS antigens of Chlamydia spp. in the sample react with a highly specifi c mixture of mono- and polyclonal antibodies forming antigen- antibody complexes.
These complexes are migrating (“lateral fl ow”, LF) along the nitrocellulose membrane and will be captured by membrane-fixed capture antibodies forming a pink-purple TEST line (B).
A correct test procedure will be indicated by a second, pinkpurple CONTROL line (C).
The used antibodies guarantee a high level of specifi city for the aetiologic detection of Chlamydia spp. antigens.

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.
• B can very both in intensity (from weak to intense pink-purple) and width. Therefore, any pink-purple line ap-pearing within the required incubation time is to be interpreted as a positive test result.
• The use of customary local anesthetic to simplify the sampling does not infl uence the test result.
• Result is only significant in a positive case. A single nega-tive result does not exclude the infection with chlamydia.

Positive test result
In the sample material used, Chlamydia spp. are present.

• Confi rmation of suspicion “chlamydiosis” in non-vacci-nated cats

• Endemic proof in a cat group (e. g. breeding, shelter) Negative test result
  In the sample material used, no Chlamydia spp. could be proven.

• No confi rmation of suspicion “chlamydiosis” in non-vaccinated cats

• Time of sampling was too early, chlamydia concentration of the sample used below the cut-off  test repetition after 1–2 days is recommended

• Sampling of only one eye  immediate testing of the other eye!

• Confi rmation of therapy  vaccination possible!

Test-kit for the qualitative detection of Chlamydia spp. antigens in discharge, extracts, organs or feces of animals

INSTRUCTIONS FOR USE

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

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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