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Chapter 3 - Testing
3.2 Serologic Testing

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This part of the Accredited Veterinarian's Manual will provide the following information necessary for serologic testing:

Objectives

Section 2 of the Health of Animals Regulations interprets "test" as including:

The reliability of any diagnostic laboratory procedure depends directly on the type of specimens or samples received and on their condition. The laboratory must receive a sample of good quality for diagnostic purposes.

Collection, materials and supplies

It is extremely important that animals are identified correctly. Animals which are tested must be uniquely identified using a approved indicator for the species being tested. Where no approved indicator exists for species tested, refer to Module 2.1 Identification of Livestock or Module 2.2 Identification of horses for more information.

Unless otherwise indicated, a minimum of a 1 ml sample of serum is required for each test.

A separate sample must be submitted for each diagnostic test required even if various tests are requested and are done at the same laboratory. Laboratories prefer separate serum samples for each test in order to maintain sample integrity. For example, if brucellosis and leptospirosis tests are requested, 2 samples are required.

For clotted blood samples:

Small (3 ml) vials with or without internal thread closures should be avoided as these are prone to leakage and may cause technical problems for the laboratory.

The costs associated with material and supplies must be paid by the accredited veterinarian.

Preparation and packaging of serum samples

Each vial must be marked indelibly with the number corresponding to the one entered on the submission form in the column under Vial No. Label the vial, not the stopper.

Paired samples must be identified with the same vial number for the same animal.

Accredited veterinarians must make sure that the packaging and shipping procedures used complies with regulations concerning the transportation of such samples.

Outer package markings checklist

  • name, address, phone number of the shipper and consignee
  • the words – "Exempt Animal Specimen" on the packaging

Statements on Shipper's Waybill

  • statement – Exempt Animal Specimen

Note: if multiple fragile primary receptacles are placed in a single secondary packaging, they must either be individually wrapped or separated to prevent contact between containers.

Long description

Pictorial representation of the minimum packaging shipping standards required for Exempt Animal Specimens

Outer packaging

Secondary packaging leakproof or siftproof (for example sealed plastic bag)

Primary receptacle leakproof or siftproof

Specimen

Absorbent packing material (for liquids)

Vials should be packed in boxes designed for this purpose in a manner to prevent breakage (for example, a New York box or styrofoam vial shipper).

The laboratory submission forms should be placed in an envelope and attached to the outside of the protective containers.

Laboratories

Most testing, mandated by the Health of Animals Act and regulations or conducted in response to a specific request by an importing country, is conducted in a CFIA laboratory or a CFIA-approved laboratory, unless specified otherwise.

Certain private laboratories are specifically approved by the CFIA to conduct official tests for Equine Infectious Anemia (EIA) and Brucellosis submitted by accredited veterinarians.

The accredited veterinarian is responsible for the laboratory fees.

All specimens sent to a CFIA or CFIA-approved laboratory must be submitted with a CFIA-approved submission form for the official test being requested.

Paper submission forms

Submission forms for samples sent to CFIA laboratories are available at the CFIA district office.

To submit brucellosis samples to a CFIA-approved laboratory, use Form CFIA/ACIA 5473 as well.

Note: for brucellosis samples collected for purposes other than export or the artificial insemination program (for example pre movement of zoological species), please consult with the local CFIA District Office for proper submission procedures.

To send EBL-CHAH samples to a CFIA laboratory, use Form CFIA/ACIA 3841 – Canada Health Accredited Herd – Serum Test Report.

For accredited veterinarians working for clinics who have applied for and been granted a "digital exemption" (refer to Module 8.4 Equine infectious Anemia), EIA samples can be sent to a CFIA-approved laboratory using Form CFIA/ACIA 3937 – Equine Infectious Anemia (EIA) Serum Test Report and Certificate.
Forms should be typed or printed and all copies must be legible.

It is the responsibility of the accredited veterinarian to provide all information required.

Digital submissions using a CFIA-approved digital EIA certification system

For accredited veterinarians working for clinics who have not been granted a "digital exemption", a CFIA-approved digital EIA certification system must be used to submit samples for EIA testing to a CFIA-approved laboratory.

The accredited veterinarian must:

For more details on the required information and digital photographs for identification, please refer to Module 8.4 Equine Infectious Anemia.

Accredited veterinarians are responsible for the security and proper use of their digital signature and shall take reasonable care to prevent its misuse.

Please contact the CFIA-approved laboratory directly to confirm what documentation or notification is required when using a CFIA-approved digital EIA certification system for sample submission. (Contact information available in Module 3.3).

Final CFIA-approved digital EIA test certificates are recognized as official EIA test results and can be accessed online in real-time by the owner (optional), the accredited veterinarian, the CFIA-approved laboratory and CFIA.

For additional information regarding the use of an approved digital EIA certification system, please contact the CFIA district office.

Special procedure for submission to CFIA laboratories

This section is applicable to samples from bovine tested in isolation (IAI notification), from sheep and goats, wild boar or cervids for export to Mexico and from bovine tested under the EBL-CHAH program

When an accredited veterinarian needs to send samples to be analyzed in CFIA laboratories from bovine under isolation notification (IAI), sheep and goats, wild boar or cervids for exportation to Mexico or bovines under the EBL-CHAH program, an Excel spreadsheet must be completed and forwarded electronically in addition to the paper form submission (CFIA Form 5473 or CFIA Form 3841) that will be attached to the samples to be sent.

The spreadsheet will be used by the CFIA laboratories to import data into the Laboratory Sample Tracking System (LSTS), preventing transcription errors and saving time, especially on larger submissions.

The template must be completed as follows:

The generic laboratory email address is not assigned to a specific laboratory and cannot be used to submit questions or requests

The electronic submission of the template does not preclude the requirement to send a paper copy of the submission form along with the sample.

Shipping samples

Include all pertinent/required forms with the samples.

The shipment of samples must never be entrusted to the animal owner or exporter.

After collection, samples are refrigerated and shipped to the laboratory without delay. Use the safest and quickest means of shipment available.

Ship samples only during the week to avoid having them delayed in transit or held over at the laboratory on weekends or holidays.

Vial breakage will require re-bleeding an animal and significantly prolong laboratory test times.

It is the responsibility of the accredited veterinarian to resubmit if a specimen is unfit for testing. Refer to the tables below for common causes of "unfit" samples.

The accredited veterinarian is responsible for shipping costs.

Criteria for rejection of samples and submission forms in CFIA animal health laboratories

CFIA and CFIA-approved labs must adhere to quality assurance standards in the receipt and testing of all samples received. CFIA-approved labs set their own internal criteria for the rejection of samples received, and have protocols in place to notify the submitters of samples rejection and the reasons for the rejection. These criteria can be obtained directly from the specific CFIA-approved lab. For samples submitted to CFIA labs, criteria for rejection are listed in the tables below.

Reasons for rejection may be related to the sample itself or the sample submission form. Notification of rejection of samples will come to the accredited veterinarian through the CFIA District Office and will consist of the submission reference number, vial(s) number(s) of the rejected samples (if applicable) and the reason for rejection. Based on the reason for rejection, the accredited veterinarian will be required to undertake the appropriate corrective measures for the sample(s) and/or the submission form in order to complete the testing.

A – General for all sample types

No. Criteria of rejection for samples Result on Record of Analysis (ROA) Comments
A1 Contamination Unfit
  • New sample is needed (with a new specimen submission form (SSF) unless extra serum from the same sample (same collection) can be provided by the submitter)
  • Contamination: sample that shows 1 or more of the following conditions: turbidity, cloudy, opacity, mucoid, gelatinous, bad smell, brownish colour, evidence of bacterial growth or of foreign material in the sample (for example feces, hair, dirt)
A2 Incorrect type of sample or container Unfit
  • New sample is needed (with a new SSF unless extra serum from the same sample (same collection) can be provided by the submitter)
  • Example: blood instead of serum or green cap instead of red cap, swab sent in inappropriate type of media, swab sent in media when it should not, etc.
A3 No ID on sample's container (vial/bag) Unfit
  • New sample is needed (with a new SSF unless extra serum from the same sample (same collection) can be provided by the submitter)
A4 Error in ID Unfit
  • New sample is needed (with a new SSF unless extra serum from the same sample (same collection) can be provided by the submitter)
A5 Duplicate samples Unfit
  • If 2 samples bear the same ID in a unique set of samples, the lab cannot assume which one is the good one (for instance pick 1 of the 2 for test)
  • The lab has to consider both duplicate samples "Unfit"
A6 Missing sample No sample received (NSR)
  • A new sample is needed (with a new SSF unless extra serum from the same sample (same collection) can be provided by the submitter)
  • If a lab has to perform 2 analyses and receives only 1 sample where the document "Animal Health Test and Analyses Performed in CFIA Lab" states that 1 sample per test is needed, the lab receives 1 sample for 1 analysis and authorizes the second analysis as NSR
A7 Extra sample Sample is not tested
  • No prior communication with the submitter before the sample is put aside
  • Example: a lab receives a SSF that lists samples 1 to 6 and samples identified 1 to 7 are in the box
  • Sample #7 will not be tested
A8 Broken vial Broken on arrival
  • New sample is needed (with a new SSF unless extra serum from the same sample (same collection) can be provided by the submitter)
A9 Insufficient volume/quantity Insufficient sample
  • New sample is needed (with a new SSF unless extra portion from the same sample (same collection) can be provided by the submitter). Includes serum, blood, straw of semen, gram of tissue, etc.
  • Refer to the AH Test and Analyses performed in CFIA Lab document to see the volume/quantity required
A10 Sets of samples with the same IDs in a unique box Unfit
  • If 2 sets of samples or more are sent in a unique box, and if some samples bear the same IDs, these samples will be reported as unfit

B – Serology samples

No. Criteria of rejection for samples Result on Record of Analysis ROA Comments
B1 Lipaemia Unfit
  • Not suitable for test
  • A new sample is needed (with a new SSF unless extra serum from the same sample (same collection) can be provided by the submitter)
  • Lipaemia: sample that has a cloudy aspect
  • Note: aliquots may not be equivalent in terms of lipaemia and lipaemia may be an issue for some assays and not for others
B2 Haemolysis Unfit
  • Not suitable for test
  • A new sample is needed (with a new SSF unless extra serum from the same sample (same collection) can be provided by the submitter)
  • Haemolysis: serum sample that is red to burgundy due to red cell lysis
  • Note: aliquots may not be equivalent in terms of haemolysis and haemolysis may be important for some assays or for others, not
B3 Fibrin clot (avian samples) Unfit
  • Not suitable for test
  • The clots makes it impossible to collect serum for analysis
  • A new sample is needed (with a new SSF unless extra serum from the same sample (same collection) can be provided by the submitter)
  • Note: the fibrin clot may appear during the transport of the samples

C – Bovine Spongiform Encephalopathy (BSE) samples

Note: BSE testing is not done under the Accredited Veterinarian Program, but accredited veterinarians may be involved in the collection of these sample on behalf of CFIA

No. Criteria of rejection for samples Result on Record of Analysis ROA Comments
C1 Damaged sample Not tested – No sample
  • The brainstem around the medulla oblongata / obex area has been sliced/severed
  • When the damage is so extensive that the obex cannot be recognized, the sample is called "Damaged, No Obex (DNO)" and the result is entered as "Not tested – No Sample"
C2 Autolyzed sample Not tested – Unsuitable
  • Tissue degradation by intrinsic enzymes
  • When the autolysis is so extensive that no brain areas can be identified the sample is called "Autolyzed-Unfit"
C3 Incorrect type of sample Not tested – No sample
  • When incorrect region of the nervous system is sent as: spinal cord, cerebellum, cerebral cortex, etc.
  • None are acceptable, even if a clinical history is provided

D – Other specific sample types

Note: these specifications apply to samples taken for routine tests and are an excerpt from the document Animal Health Tests and Analyses performed in CFIA laboratories

No. Criteria of rejection for samples Result on Record of Analysis ROA Comments
D1 Avian Influenza Unfit
  • Pool: serum pooled
  • Swabs: Universal Transport Medium (UTM) containing swabs, mix of cloacal and tracheal in the same UTM.
D2 Avian Paramyxovirus (Newcastle Disease) Unfit
  • Swabs: UTM containing swabs, mix of cloacal and tracheal in the same UTM
D3 Bovine Viral Diarrhea Unfit
  • State: serum frozen for virus isolation (ISOL) test, semen not frozen and not shipped in liquid nitrogen dry shipper
D4 Campylobacter fetus Unfit
  • Age: sample older than 48 hours
  • Temperature: sample temperature outside of 18-37°C
D5 Contagious Equine Metritis Unfit
  • Age: sample older than 48 hours
  • State: sample frozen for culture test
D6 Cysticercosis Unfit
  • State: sample frozen
D7 Elaphostrongylus cervi Unfit
  • State: sample frozen
D8 In-vitro fertilized embryo – virus isolation Unfit
  • State: sample not frozen and not shipped in liquid nitrogen dry shipper
D9 Infectious Bovine Rhinotracheitis Unfit
  • State: semen not frozen and not shipped in liquid nitrogen dry shipper
D10 Mycoplasma Unfit
  • Age: sample older than 48 hours for culture test
  • State: semen not frozen and not shipped in liquid nitrogen dry shipper
D11 Salmonella Unfit
  • Age: sample older than 48 hours for culture test
D12 Tritrichomonas (Trichomonosis) Unfit
  • Age: sample older than 120 hours for culture test
  • Temperature: sample temperature outside of 10-37°C
D13 Turkey Rhinotracheitis (TRT) Unfit
  • Pool: serum pooled
  • Swabs: UTM containing swabs, mix of cloacal and tracheal in the same UTM
D14 All Histopathology tests (for example Cysticercosis, TB) Unfit
  • State: samples frozen

Test results

The accredited veterinarian is responsible for advising the owner of the results.

Test results reported from CFIA laboratories are generated through the Laboratory Sample Tracking System (LSTS).

Test results from CFIA-approved laboratories are usually reported directly to the submitter and the CFIA district office.

For additional information on distribution of test results when using a CFIA-approved electronic EIA certification system, please refer to Module 8.4 Equine Infectious Anemia.

Test results from private laboratories are usually reported directly to the submitter only. The accredited veterinarian will provide a copy of such test results to CFIA upon request.

Schedule testing so as to allow sufficient time to receive results.

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