American Society For Veterinary Clinical Pathology Research Articles

Development of reference intervals for serum biochemistry and haematology of juvenile green sea turtles (Chelonia mydas) in a Thai rehabilitation centre.

No reference intervals for serum biochemistry and haematology of sea turtles in Thailand exists to assist veterinarians who are responsible for sea turtle health management and treatment. This study determined serum biochemistry and basic haematology of healthy juvenile green sea turtles (n = 92) in captivity in Thailand following the American Society for Veterinary Clinical Pathology (ASVCP), Quality Assurance and Laboratory Standards Committee (QALS) guidelines for the determination of reference intervals in veterinary species. Biochemistry tests, including blood urea nitrogen, creatinine, uric acid, alanine aminotransferase, aspartate aminotransferase and alkaline phosphatase were analysed using an IDEXX VetTest Chemistry Analyzer. Haematology parameters were measured manually using a microhaematocrit for packed cell volume (PCV), Neubauer counting chamber for red blood cell count and cyanmethemoglobin method for haemoglobin concentration. mean corpuscular volume and mean corpuscular haemoglobin concentration were calculated using the PCV, red blood cell count and haemoglobin. Turtles in this study were found to have higher mean values for PCV (28.70%), haemoglobin (92.13 g/L), mean corpuscular haemoglobin concentration (327.03 g/L), uric acid (247.15 μmol/L), alanine aminotransferase (16.53 IU/L), aspartate aminotransferase (209.44 IU/L), and alkaline phosphatase (245.08 IU/L) compared to sea turtles in Brazil. The reference intervals established using high numbers of healthy turtles in this study will assist veterinarians with diagnostic and treatment decisions when evaluating laboratory results for juvenile green sea turtles.

Establishment of Hematological and Plasma Biochemical Reference Values and Analysis of Risk Factors for Pet Sugar Gliders (Petaurus breviceps) in Taiwan.

Hematological and plasma biochemical examination are crucial in the veterinary care of sugar gliders, which are increasingly popular in Taiwan and the United States. However, published research of the species' reference interval and related influencing factors were rare. The objectives of this study were to establish the hematological and plasma biochemical reference values for captive sugar gliders in Taiwan and to evaluate the influence of factors including age, gender, neuter status, location, season, diet, caging arrangement, and other pets in the household. A total of 42 clinically healthy pet sugar gliders were recruited. Morphometrical measurements and physiological data were collected, and hematological and plasma biochemical examinations were performed. The reference value of each index was calculated using Reference Value Advisor (RVA) software, following the American Society for Veterinary Clinical Pathology (ASVCP) guidelines. Normality of data distribution was tested, and data transformation was conducted. The parametric method and robust method were used to determine reference limits. Univariate analysis was performed, and multiple regression models were built for each hematological and plasma biochemical parameter. Red blood cell, hematocrit, and hemoglobin levels were higher in males, compared to females, while they were lower in the neutered group, compared to the intact group. Relative neutrophil counts were higher in elder sugar gliders, while relative lymphocyte counts were lower. Aspartate transaminase levels were higher in elder sugar gliders, while albumin levels were lower. Blood urea nitrogen levels were highest in spring. The blood profile and related effects presented in this study can provide useful information for veterinary care in pet sugar gliders.

American Society for Veterinary Clinical Pathology-Recommended Clinical Pathology Competencies for Graduating Veterinarians.

Given the move toward competency-based veterinary education and the subsequent reevaluation of veterinary curricula, there is a need for specialties to provide guidance to veterinary college administrators and educators on the core knowledge and skills pertaining to their specialty to ensure their inclusion in revised or redesigned curricula. The American Society for Veterinary Clinical Pathology (ASVCP) Education Committee sought to create a list of competencies specific to clinical pathology expected of graduating veterinarians. The stimulus for this project was the American Veterinary Medical Association Council on Education Standards of Accreditation for Colleges of Veterinary Medicine, further driven by the 2018 publication of the Association of American Veterinary Medical Colleges Competency-Based Veterinary Education Working Group framework. The recommendations made in this document are the culmination of the 2016 ASVCP Education Forum for Discussion, multiple remote subcommittee communications, and feedback obtained from ASVCP membership. The final framework includes 8 clinical pathology-focused domains of competence with 20 clinical pathology competencies and 61 clinical pathology illustrative sub-competencies. The clinical pathology-focused domains of competence are: the pre-analytical phase of testing, laboratory medicine and instrumentation, principles of test selection and interpretation, hematology and hemostasis, chemistry, endocrinology, urinalysis, and cytology. These are not intended to replace the nine established AAVMC domains of competence with supportive competencies and illustrative sub-competencies but to guide institutions for how clinical pathology aligns within the competency-based veterinary education (CBVE) framework for the practice-ready veterinary graduate. This clinical pathology competency framework may prove useful and empowering during discussions of curriculum revisions and redesigns.

Suggested guidelines for validation of real-time PCR assays in veterinary diagnostic laboratories.

This consensus document presents the suggested guidelines developed by the Laboratory Technology Committee (LTC) of the American Association of Veterinary Laboratory Diagnosticians (AAVLD) for development, validation, and modification (methods comparability) of real-time PCR (rtPCR) assays. These suggested guidelines are presented with reference to the World Organisation for Animal Health (OIE) guidelines for validation of nucleic acid detection assays used in veterinary diagnostic laboratories. Additionally, our proposed practices are compared to the guidelines from the Foods Program Regulatory Subdivision of the U.S. Food and Drug Administration (FDA) and from the American Society for Veterinary Clinical Pathology (ASVCP). The LTC suggestions are closely aligned with those from the OIE and comply with version 2021-01 of the AAVLD Requirements for an Accredited Veterinary Medical Diagnostic Laboratory, although some LTC recommendations are more stringent and extend beyond the AAVLD requirements. LTC suggested guidelines are substantially different than the guidelines recently published by the U.S. FDA for validation and modification of regulated tests used for detection of pathogens in pet food and animal-derived products, such as dairy. Veterinary diagnostic laboratories that perform assays from the FDA Bacteriological Analytical Method (BAM) manual must be aware of the different standard.

Investigation of the Status Quo of Veterinary Point-of-Care Laboratories in Switzerland: Availability, Application, and Quality Management.

The extent to which Swiss veterinary practitioners follow the guidelines for quality assurance of the American Society for Veterinary Clinical Pathology (ASVCP) for point-of-care (POC) testing is unknown. Thus, the aim of this study was to assess the availability, application, and quality management of POC analyzers in Swiss veterinary practices/clinics. For this purpose, we created an online questionnaire on laboratory equipment, quality management, and biosafety, which all members of the Society of Swiss Veterinarians (GST) were invited to complete. In total, 192 clinics/practices participated, of which 69% had automated POC analyzers, mainly for clinical chemistry (99%) and/or hematology (86%). Sample analyses and equipment maintenance were mostly performed by veterinary technicians (81% and 68%, respectively). Reference intervals were adopted from manufacturers (80%) or literature (17%). The results showed that most participants perform basic internal quality control (chemistry: 75%; hematology: 86%), and many use at least two levels of quality control material (47%-48%). Controls are mostly run once a month (chemistry: 36%; hematology: 35%) or ≤4 times/year (36% and 25%). Only three clinics/practices reported participation in an external quality assessment program; comparative testing was more common (chemistry: 42%; hematology: 52%). Only one-quarter of the participants stated that they make use of the data generated through internal and external quality control measures. In conclusion, POC analyzers are widely available in Swiss veterinary clinics/practices, and internal quality control is performed to some extent. However, quality assessment and management and biosafety awareness and measures need to be improved, ideally with the support of clinical pathologists.

American Society for Veterinary Clinical Pathology (ASVCP) 51th Annual Meeting In conjunction with the American College of Veterinary Pathologists (ACVP) 67th Annual Meeting, New Orleans, LA—December 3‐7, 2016

Veterinary Clinical PathologyVolume 48, Issue 3 p. 499-521 ABSTRACTS American Society for Veterinary Clinical Pathology (ASVCP) 51th Annual Meeting In conjunction with the American College of Veterinary Pathologists (ACVP) 67th Annual Meeting, New Orleans, LA—December 3-7, 2016 First published: 22 September 2019 https://doi.org/10.1111/vcp.12782Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat Volume48, Issue3September 2019Pages 499-521 RelatedInformation

Hemolymph cytology, hemocyte count, glucose, and electrolyte reference intervals in 93 Cameroon red tarantulas (Hysterocrates gigas).

Theraphosidae is a large family of tarantula spiders commonly kept as pets or display animals by zoological institutions. Interest and demand for arachnid medicine have grown over the last decade. While hemolymph analysis could be a fundamental tool for arachnid health assessment, RIs are generally lacking for arachnid species. The objectives of this study were to describe the appearance of hemocytes and establish RIs for total and differential hemocyte counts as well as hemolymph glucose and electrolyte concentrations in the Cameroon red tarantula (CRT) (Hysterocrates gigas). Ninety-three CRTs were anesthetized using isoflurane or sevoflurane, and hemolymph was collected from the heart. Hemocyte counts were performed using a hemocytometer and trypan blue stain, and differential cell counts were estimated using light microscopy and a Wright stain. Hemocytes were also characterized with transmission electron microscopy (TEM). Hemolymph glucose and electrolyte concentrations were obtained using a blood gas analyzer. The American Society for Veterinary Clinical Pathology (ASVCP) guidelines were used to calculate RIs. The most abundant hemocytes were plasmatocytes, followed by granulocytes, cyanocytes, and prohemocytes. Hemocytes were characterized by TEM except for cyanocytes. All RIs had a broad range, likely due to a combination of population heterogeneity, high biologic variability of the species, and the propensity of samples to clot. The current study is the first to establish RIs for hemolymph cytologic parameters with a sample size of over 20 individuals in any theraphosid species. RIs for CRT hemolymph biochemical analytes are also reported.

Establishment of feline in-house reference intervals for hematologic and biochemical parameters and potential age-related differences.

Reference intervals (RIs) are one of the essential elements in the procedure of disease diagnosis. This is especially true for feline species in which RI is less available than in canine species. RIs are affected by biological, geographical and instrumental factors, yet published RIs with incomplete background are popularly used. Inappropriate interpretations of RIs may affect classification of disease and subsequent treatment. In this study, we demonstrated the step-by-step establishment of feline RIs following the American Society for Veterinary Clinical Pathology (ASVCP) reference interval guideline. A total of 51 parameters were examined, including 20 hematology and 31 biochemistry parameters, and the results were compared to one local RI and two foreign RIs. Overall, about 29% (10/35) of tested parameters were different form local RIs and 60% (30/50) were different from the two foreign RIs, highlighting geographical variations. A higher upper reference limit (URL) in red blood cell count (RBC), hematocrit (Hct), Hemoglobin (Hgb), albumin, creatinine and lower URL in potassium and white blood cell count (WBC) were identified, which may impact the interpretation. In addition, statistical analysis of age and gender were factored separately and indicated that 10 parameters were significantly higher in the adult group. For the impact of gender, percentage of basophil and total iron-binding capacity (TIBC) were lower in female and male cats, respectively. In conclusion, we have demonstrated that it is desirable to establish in-house RIs or RIs of local sources. An age specific RI for the geriatric feline population is advisable for better diagnosis and monitoring the disease.

Intraocular pressure reference intervals in eyes of clinically normal miniature donkeys (Equus africanus asinus).

To determine intraocular pressure (IOP) reference intervals in eyes of healthy miniature donkeys (Equus africanus asinus) via rebound and applanation tonometry. Complete ophthalmic and physical examinations were performed by board-certified veterinary ophthalmologists. Inclusion criteria for animals participating in this study were dictated by the American Society for Veterinary Clinical Pathology (ASVCP) reference interval guidelines. Intraocular pressure estimates (TonoVet® and TonoPen XL® ) were obtained in both eyes. Forty animals (San Angelo group) received intramuscular xylazine hydrochloride 10% and auriculopalpebral (AP) nerve blocks prior to obtaining measurements. Twenty-two animals (Austin group) received no sedation or AP block. Statistical analysis followed ASVCP reference interval guidelines. Analysis was performed using the software sas V9 (SAS Institute Inc., Cary, NC, USA). Fifty-seven (114 eyes) healthy miniature donkeys were included in this study. The mean IOP ± standard deviation (SD) was 25.75±5.70mmHg for rebound tonometry with reference limits of 14.34 and 37.15. The mean IOP ± SD was 20.69±5.06mmHg for applanation tonometry with reference limits of 12.82 and 33.38. No significant difference in IOP was found between the Austin and San Angelo groups (P=.34). A significant difference was noted between rebound and applanation IOP estimates (P<.0001) with rebound tonometric values being higher. Reference intervals for IOP's were established for this species. Intraocular pressure readings obtained by the rebound tonometer were significantly higher than with applanation. Sedation and AP block did not affect IOP estimates.

Hematology RIs for captive and wild Arabian Sand Gazelles (Gazella subgutturosa marica) of the Kingdom of Saudi Arabia.

The Arabian Sand Gazelle (Gazella subgutturosa marica, Thomas, 1897) has been extirpated throughout the Arabian Peninsula. Captive breeding and reintroduction for conservation purposes require veterinary support and the use of hematology RIs. The purpose of the study was to establish hematological RIs for the Arabian Sand Gazelle. Blood from 231 clinically healthy captive and 22 wild (reintroduced) Arabian Sand Gazelles were sampled. The VetScan HM2 analyzer was used to determine the complete cell count (CBC) on the same morning of sample collection. American Society for Veterinary Clinical Pathology (ASVCP) guidelines were followed for statistical analyses. The white blood cell counts (WBC) and hematocrits (HCT) revealed broad RIs, the red blood cell counts (RBC) and hemoglobin (HGB) were characterized by a narrow RI, and the platelet count (PLT) yielded a wide RI due to high variance in the data. The HGB, MCHC, PLT, and platelet distribution width (PDW) were significantly different between the captive males and females. The majority of the variables assessed were significantly different between captive and wild animals. The large number of samples obtained for this study was considerable given the rare and endangered status of this species, which overall afforded narrow RIs and CIs. The main exception was for the PLT constituents. The significant differences observed between the captive and wild male gazelles show the need to understand the origin of the animals for which hematologic RIs are determined.

Reference intervals for biochemical blood variables, packed cell volume, and body temperature in pet rats (Rattus norvegicus) using point-of-care testing.

Rats (Rattus norvegicus) are increasingly kept as pets, thus more and more requiring veterinary care. Important differences exist between pet and laboratory rats, but little information is available on pet rats. Diagnosis and treatment of pet rat diseases would benefit from RIs specific for this animal population. The aim was to establish RIs for biochemical blood variables, PCV, and body temperature in pet rats. Additionally, influences of sex and feed rationing method (ad libitum, restricted) on these variables were determined. American Society for Veterinary Clinical Pathology (ASVCP) recommendations were followed. Biochemical variables were measured using an automated chemistry analyzer, the VetScan VS2. Nonparametric statistical methods were used to determine RIs and effects of sex and feed rationing method. Reference intervals were established using values of 123 clinically healthy pet rats (except for globulins and albumin/globulin ratio, n = 120) and were: glucose 6.6-13.7 mmol/L, total proteins 66-88 g/L, albumin ≥ 38 g/L, globulins 12-35 g/L, albumin/globulin ratio 1.0-4.7, urea nitrogen 2.5-6.6 mmol/L, creatinine ≤ 53 μmol/L, total bilirubin 4-7 μmol/L, ALP 40-442 IU/L, ALT 22-137 IU/L, amylase 502-1113 IU/L, sodium 133-144 mmol/L, potassium 3.6-5.3 mmol/L, calcium 9.5-10.9 mg/dL, phosphorus 2.3-7.0 mg/dL, PCV 40-50%, and body temperature 35.8-39.3°C. Sex significantly affected 10 variables. No significant influence was found with feed limitation CONCLUSIONS: Reference intervals reported in this study will be useful for interpretation of biochemistry analysis in pet rats and therefore improve pet rat medicine.

ESTABLISHING IN-HOUSE REFERENCE INTERVALS FOR DOGS IN VETERINARY CLINICS

Reference interval (RIs) were critical to the identification of illness. However, RIs set in one laboratory may not be appropriate for another because of biological, geographical and instrumental factors. Interpretation of clinical data using inappropriate RIs may cause misclassification of results and misdiagnosis that lead to improper treatment. RIs in Taiwan have been mostly referencing from foreign resources, it is desirable to establish one that is closer to the overall conditions in Taiwan (such as breed, climate, diseases, etc.) and to investigate its differences to foreign RIs. The present study used the American Society for Veterinary Clinical Pathology (ASVCP) guidelines to establish in-house RIs for hematological, biochemical and coagulation parameters using dogs in middle Taiwan. The results were also compared to two foreign and one local RIs. The results suggested that the hematological RIs are more comparable to foreign RIs than the biochemical and hemostatic parameters. Differences were found for biochemical parameters including gamma-glutamyl transferase (GGT), lactate dehydrogenase (LDH), lipase, uric acid, bile acid, bilirubin and magnesium; and coagulation parameters including prothrombin time (PT) and activated partial thromboplastin. In all, 18% (7/40) of the all tested parameters were different from the local RI while 38% (18/48) and 41% (19/46) of the parameters were different from the two foreign RIs. The differences in more than 30% RIs and better similarities to local RIs underscore the importance of having own RIs if possible.

Comparisons of results between three in-house biochemistry analyzers and a commercial laboratory analyzer for feline plasma using multiple quality specifications

In-house plasma biochemistry analysis is commonplace in veterinary practice but there are few studies assessing the results from such instruments. Method comparison in human clinical pathology uses results from both precision and bias studies to determine whether results fall within a margin of “acceptable” or “allowable” total error. This study aimed to assess the clinical acceptability of plasma biochemistry results determined by in-house analyzers compared to a commercial laboratory analyzer. Clinical acceptability of analytes from in-house biochemistry analyzers was assessed by determining the percentage of results from feline plasma samples within coverage ranges determined from (a) biological variation, (b) those published by the American Society for Veterinary Clinical Pathology (ASVCP), as well as (c) calculated total error and (d) expanded measurement uncertainty. Calculated total error and expanded measurement uncertainty ranges were calculated from prior quality control material analyses. Between 80 to 87 % of results fell within minimal quality standards determined from biological variation. Approximately 90 % of results fell within “acceptable total error” ranges published by ASVCP. Overall, in-house analyzers provide acceptable results, with few clinical decisions affected by results determined from any of the three in-house analyzers compared to the commercial laboratory results.

Best practices for veterinary toxicologic clinical pathology, with emphasis on the pharmaceutical and biotechnology industries

The purpose of this paper by the Regulatory Affairs Committee (RAC) of the American Society for Veterinary Clinical Pathology (ASVCP) is to review the current regulatory guidances (eg, guidelines) and published recommendations for best practices in veterinary toxicologic clinical pathology, particularly in the pharmaceutical and biotechnology industries, and to utilize the combined experience of ASVCP RAC to provide updated recommendations. Discussion points include (1) instrumentation, validation, and sample collection, (2) routine laboratory variables, (3) cytologic laboratory variables, (4) data interpretation and reporting (including peer review, reference intervals and statistics), and (5) roles and responsibilities of clinical pathologists and laboratory personnel. Revision and improvement of current practices should be in alignment with evolving regulatory guidance documents, new technology, and expanding understanding and utility of clinical pathology. These recommendations provide a contemporary guide for the refinement of veterinary toxicologic clinical pathology best practices.

Current quality assurance concepts and considerations for quality control of in-clinic biochemistry testing

Quality assurance is an implied concept inherent in every consumer's purchase of a product or service. In laboratory testing, quality assurance encompasses preanalytic (sampling, transport, and handling prior to testing), analytic (measurement), and postanalytic (reporting and interpretation) factors. Quality-assurance programs require that procedures are in place to detect errors in all 3 components and that the procedures are characterized by both documentation and correction of errors. There are regulatory bodies that provide mandatory standards for and regulation of human medical laboratories. No such regulations exist for veterinary laboratory testing. The American Society for Veterinary Clinical Pathology (ASVCP) Quality Assurance and Laboratory Standards Committee was formed in 1996 in response to concerns of ASVCP members about quality assurance and quality control in laboratories performing veterinary testing. Guidelines for veterinary laboratory testing have been developed by the ASVCP. The purpose of this report was to provide an overview of selected quality-assurance concepts and to provide recommendations for quality control for in-clinic biochemistry testing in general veterinary practice.

American Society for Veterinary Clinical Pathology (ASVCP) 47th Annual Meeting

The interpretation of the urinary protein to creatinine ratio(UPC) in urine samples with concurrent hematuria can be confusing, as blood may increase the protein level measured in the urine. To mimic hematuria, blood from 18 dogs was added to their own urine sample in increasing levels (from 0 to 5%) to determine whether the urine color for varying degrees of blood contamination can be utilized to aid interpretation of the validity of the UPC results. For each urine sample, urinary protein and creatinine were measured biochemically, urine dipstick analysis, specific gravity by refractometry and microscopic sediment examination were performed, and the urine color was visually assessed. A complete blood count (CBC) and serum biochemistry panel were performed on each dog. Blood contamination of the urine that did not result in a visible change in color of the urine sample from yellow (i.e., microscopic hematuria) did not increase the UPC above the normal range of <0.5. As such, in the presence of microscopic hematuria, the UPC level in yellow urine (with no evidence of concurrent urinary tract inflammation) should be considered valid. Thus, the practice of discouraging UPC assessment in animals with microscopic hematuria should be discontinued. However, hematuria that results in a visible color change from yellow may increase the UPC above 0.5. In this situation hematuria would need to be considered as a differential diagnosis for the proteinuria.

ASVCP quality assurance guidelines: control of preanalytical and analytical factors for hematology for mammalian and nonmammalian species, hemostasis, and crossmatching in veterinary laboratories

In December 2009, the American Society for Veterinary Clinical Pathology (ASVCP) Quality Assurance and Laboratory Standards committee published the updated and peer-reviewed ASVCP Quality Assurance Guidelines on the Society's website. These guidelines are intended for use by veterinary diagnostic laboratories and veterinary research laboratories that are not covered by the US Food and Drug Administration Good Laboratory Practice standards (Code of Federal Regulations Title 21, Chapter 58). The guidelines have been divided into 3 reports: (1) general analytical factors for veterinary laboratory performance and comparisons; (2) hematology, hemostasis, and crossmatching; and (3) clinical chemistry, cytology, and urinalysis. This particular report is one of 3 reports and provides recommendations for control of preanalytical and analytical factors related to hematology for mammalian and nonmammalian species, hemostasis testing, and crossmatching and is adapted from sections 1.1 and 2.3 (mammalian hematology), 1.2 and 2.4 (nonmammalian hematology), 1.5 and 2.7 (hemostasis testing), and 1.6 and 2.8 (crossmatching) of the complete guidelines. These guidelines are not intended to be all-inclusive; rather, they provide minimal guidelines for quality assurance and quality control for veterinary laboratory testing and a basis for laboratories to assess their current practices, determine areas for improvement, and guide continuing professional development and education efforts.

ASVCP quality assurance guidelines: control of preanalytical, analytical, and postanalytical factors for urinalysis, cytology, and clinical chemistry in veterinary laboratories

In December 2009, the American Society for Veterinary Clinical Pathology (ASVCP) Quality Assurance and Laboratory Standards committee published the updated and peer-reviewed ASVCP Quality Assurance Guidelines on the Society's website. These guidelines are intended for use by veterinary diagnostic laboratories and veterinary research laboratories that are not covered by the US Food and Drug Administration Good Laboratory Practice standards (Code of Federal Regulations Title 21, Chapter 58). The guidelines have been divided into 3 reports: (1) general analytical factors for veterinary laboratory performance and comparisons; (2) hematology, hemostasis, and crossmatching; and (3) clinical chemistry, cytology, and urinalysis. This particular report is one of 3 reports and documents recommendations for control of preanalytical, analytical, and postanalytical factors related to urinalysis, cytology, and clinical chemistry in veterinary laboratories and is adapted from sections 1.1 and 2.2 (clinical chemistry), 1.3 and 2.5 (urinalysis), 1.4 and 2.6 (cytology), and 3 (postanalytical factors important in veterinary clinical pathology) of these guidelines. These guidelines are not intended to be all-inclusive; rather, they provide minimal guidelines for quality assurance and quality control for veterinary laboratory testing and a basis for laboratories to assess their current practices, determine areas for improvement, and guide continuing professional development and education efforts.

American Society for Veterinary Clinical Pathology (ASVCP) 46th Annual Meeting

American Society for Veterinary Clinical Pathology (<scp>ASVCP</scp>) 46th Annual Meeting

Best Practices for Clinical Pathology Testing in Carcinogenicity Studies

The Society of Toxicologic Pathology (STP) and American Society for Veterinary Clinical Pathology (ASCVP) convened a Clinical Pathology in Carcinogenicity Studies Working Group to recommend best practices for inclusion of clinical pathology testing in carcinogenicity studies. Regulatory guidance documents and literature were reviewed, and veterinary pathologists from North America, Japan, and Europe were surveyed regarding current practices, perceived value, and recommendations for clinical pathology testing in carcinogenicity studies. For two-year rodent carcinogenicity studies, the Working Group recommends that clinical pathology testing be limited to collection of blood smears at scheduled and unscheduled sacrifices to be examined only if indicated to aid in the diagnosis of possible hematopoietic neoplasia following histopathologic evaluation. Additional clinical pathology testing is most appropriately used to address specific issues from prior toxicity studies or known test article-related class effects. Inadequate data were available to make a recommendation concerning clinical pathology testing for alternative six-month carcinogenicity assays using genetically modified mice, although the Working Group suggests that it may be appropriate to use the same approach as for two-year carcinogenicity studies since the study goal is the same.