MEGACOR FASTest GIARDIA Strip Instruction Manual

: June 9, 2024
: MEGACOR

Table of Contents

FASTest GIARDIA Strip
INTRODUCTION
INFORMATION ON THE SPECIMEN MATERIAL
SPECIMEN COLLECTION AND PREPARATION
TEST PROCEDURE
READING OF THE TEST RESULT
PRECAUTIONS FOR USERS
TEST PRINCIPLE
INFORMATION FOR THE INTERPRETATION
Documents / Resources

Version 01/2022
Click Here For More Information About FASTest ® GIARDIA Strip
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Test-kit for the qualitative detection of Giardia duodenalis antigens in the faeces of pocket pets,
pets and farm animals
INSTRUCTIONS FOR USE
In vitro diagnosticum

FASTest GIARDIA Strip

INFORMATION ON THE TEST-KIT TEST-KIT COMPONENTS 1 test-kit FASTest ® GIARDIA Strip contains:
– 2, 10 or 25 dipsticks coated with monoclonal antibodies – 2, 10 or 25 sample tubes with 2.0 ml buffer diluent each – 1 instructions for use

STABILITY AND STORAGE

Store at
15–25 °C| Expiry date
– see label
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APPLICATION AND ABBREVIATIONS

For veterinary use only	Lot number
In vitro diagnosticum	Do not use test-kit components from different kits,

lot numbers or beyond stated expiry date.
Follow instructions for use precisely| TL – TEST line, CL – CONTROL line, LF – Lateral ﬂ ow R – Revolver test tube, P – sample tube

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 97.2 %
Speciﬁcity 99.5 %
(Comparison Method: ELISA)

INTRODUCTION

Giardia is known to be one of the most common enteritis parasites in pocket pets, pets, farm and wild animals as well as in humans (zoonosis) world-wide. G. duodenalis occurs in varying phenotype (A to G), which differ in their interactivity and their host spectrum. Types A and B have zoonotic potential. Newborns and young animals are costly affected. Prevalences vary in cats and dogs, depending on age (>70 % under 1 year), husbandry (10 % in single husbandry up to 100 % in breeding and animal shelters) and mmune status.
Transmission (direct contact, by contaminated food, water, objects, grooming and vectors like ﬂies etc.) happens fecal-orally by ingestion of highly infectious and very resistant cysts being discharged by other animals or humans. Only ﬁve to ten cysts are enough to cause an infection.
G. duodenalis has an asexual life cycle. In the uodenum of the infected animals, two so-called trophozoites emerge from the incorporated cysts (excystment).
These multiply by duplication and attach via suckers to the duodenal surface.
Free trophozoites turn into their permanent forms, the cysts (encystment), especially in the ileum. These are excreted in large amounts (10 7 /g faeces) and mostly intermittent, i. e. not with every defecation. The prepatent period averages 5 to 16 days.
The main symptom of giardiasis is diarrhoea, more or less intensive, that can run from symptomatic (acute, chronic, self-limiting, periodic-intermittent or continuous) to asymptomatic. Independent on the progression, cysts and / or trophozoites can be egested (primarily with strong diarrhoea).
Giardia cysts can be differentiated from cysts of different coccidia species only by microscopically experienced people. This is lso true for Giardia and Tritrichomonas foetus trophozoites.
For that reason, modern aetiological coprodiagnostics using FASTest ® GIARDIA Strip should be preferred to microscopical proof. For epidemiological reasons, all clinically symptomatic and clinically asymptomatic animals should be tested with FASTest ®
GIARDIA Strip. This enables the veterinarian in the clinic to introduce a speciﬁc treatment as well as a broad prophylaxis.

INFORMATION ON THE SPECIMEN MATERIAL

Due to the normally inhomogeneous or nest-like dissemination of antigens in the faeces, the specimen material has to be mixed up homogeneously (spatula, vortex-mixer) before sampling. For the test, the required amount of faeces as described in point 4b / Specimen collection and preparation, is needed. The amount depends on the consistency of the sample. Use the attached spoon.
Non-cooled (15–25 °C), the sample should be tested within 4 hours! At 2–8 °C, the sample can be stored up to 4 days, permanently 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. proteases, mucosa components, blood, but also viscosity, pH-value as well as grass and cat litter) can ause 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

a. Open the sample tube with the buffer diluent.
b. Mix the faeces sample homogeneously (applicator, vortexer). Then mix the required sample volume (compact:

1 level spoon, pulpy: 2 level spoons, ﬂuid-watery: 3 level spoons of faeces) steadily into the buffer diluent (ﬁg.1).
c. Close sample tube tightly and rotate it easily to get the mixture as homogeneous as possible (ﬁg.2).
d. For sedimentation of gross faeces particles place the sample tube on a ﬂ at and horizontal surface for 1–5 min- utes.

TEST PROCEDURE

Remove the dipstick from its foil pouch shortly before use.
Introduce the dipstick vertically and with the arrows pointing downwards into the sample tube for at least 1 minute. The liquid level (meniscus!) must not exceed the white arrowheads (ﬁg.3).
Remove the dipstick from sample tube as soon as the sample-buffer mixture (SBM) has reached the CL. If so, the blue CL will appear slowly but surely (ﬁg.4 / 5). If the
CL does not appear after 5–10 minutes, a new SBM must be prepared and sedimented for at least 5 minutes. The dipstick must be held only in the supernatant until the LF has reached the CL (see also 7. Precautions for users*).
Place the dipstick on a ﬂ at and horizontal surface for incubation.

READING OF THE TEST RESULT

Read the test result after 5 (max.10) minutes.
Positive test results may be observed earlier, depending on the concentration of antigen in the sample.
POSITIVE TEST RESULT (ﬁg.4)
A red TEST line of any intensity (varying from very weak to strongly intensive) and a blue CONTROL line appear.
NEGATIVE TEST RESULT (ﬁg.5)
Only a blue CONTROL line appears. This line indicates, irrespective of its intensity, that the test has been performed properly. Please also note issue 9.4.
INVALID TEST RESULT
No CONTROL line visible. 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 (protective clothing, possibly a face mask). Wash and disinfect hands after completing the test.
Label sample material and associated sample tube to ensure a precise assignment.
Use a new sample tube 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.
To avoid an application error / external inﬂ uence (e. g. too much sample material, too short sedimentation time, components in the faeces that clog the pores of the suction pad), the test can be repeated. Use a new dipstick and carefully observe the sample preparation. It is advisable to only hold the dipstick in the supernatant when repeating the test until the LF has reached the CL.

TEST PRINCIPLE

The FASTest ® GIARDIA Strip is based on latest rapid immunochromatographic technique.
Surface antigens of intact or fractionated Giardia duodenalis cysts and / or trophozoites will react at the conjugate pad with mobile antibodies bound to red latex particles. Migrating (“lateral ﬂ ow”, LF) along the nitrocellulose membrane, these speciﬁ c antigen-antibody complexes are bound by ﬁ xed monoclonal anti-Giardia antibodies (mAbs) producing a red TEST line (TL). The intensity or width of the TL depends on the concentration of Giardia antigens in the introduced amount of sample.
A correct test procedure will be indicated by a second, blue CONTROL line (CL). The used mAbs guarantee a high level of speciﬁ city for the aetiologic detection of G. duodenalis antigens.
The FASTest ® GIARDIA Strip does not rely on the presence of intact cysts and / or trophozoites.

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 10 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 intense red) and width. Therefore, any red line appearing within the required incubation time is to be interpreted as a positive test result.
Because of intermittent antigen shedding, with ongoing diarrhoea a single negative test result should be conﬁ rmed by testing a serial faeces sample (individual test- ing of at least three consecutive faeces samples).
Drug therapy can lead initially to an increase of cyst and / or trophozoite shedding. Reinfections due to the prepatence could also appear. Both could result in positive test results. First of all, therapy control should be based on clinical symptoms (decrease of diarrhoea in quantity and quality), not only of a single test result. 6. Be aware, every dog or cat tested positive is considered potentially infectious for animals and humans (zoonosis!), especially for kids!

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