Comparing biomedical collections over time
Introduction
The IHMHS is the second time the ABS has collected information on biomedical indicators. Biomedical indicators were first collected as part of the National Health Measures Survey (NHMS) 2011–12 and the National Aboriginal and Torres Strait Islander Health Measures Survey (NATSIHMS) 2012–13. In both collections, information was collected for the general population and for Aboriginal and Torres Strait Islander peoples. The ABS anticipates that users will have interest in comparing these collections to understand changes in biomedical information over time.
However, there are a range of factors that may impact the comparability of survey results across time. In some cases, it may be difficult to distinguish between changes due to methods, changes due to equipment updates, and/or changes due to biological trends. Users should be aware of these factors when comparing results between ABS biomedical collections. This page presents information on known changes in pathology test methodology and equipment between 2011–13 and 2022–24 for users looking to compare data across time.
Pathology testing methodology and equipment
The approximately 10-year time period between the 2011–13 and 2022–24 biomedical collections significantly exceeds the life of most laboratory equipment. While the same pathology provider conducted the testing in 2011–13 and 2022–24 using a single laboratory, in some cases equipment for specific tests changed and/or the method of analysis changed in that time.
Verification and validation processes were conducted by the pathology provider each time a method and/or equipment was upgraded. Whilst these processes were robust, it was not always possible to directly verify current instrumentation and methods of analysis used in the 2022–24 against that used for in 2011–13 due to more than one change having been made. In addition to equipment changes, reagent lots may have changed, and calibrators and traceability may have improved. Internal procedures were in place for new batches of reagents and assays to check and adjust for results drift.
The precision of the methods (± x%) for each biomedical test needs to be considered when comparing results from old and new methods, in this case when interpreting observed changes in patient means between the two survey periods (i.e. whether observed changes are within the accepted precision range or not). New instruments tend to be more sensitive than older ones, with positive results at the lower end of the distribution that would not have been reported using older instruments.
To understand the impacts of changes in pathology methodology and equipment, the ABS commissioned expert advice on the equivalence of the individual tests in the 2022–24 with those undertaken in 2011–13. This work looked at the viability of using a range of various analytical tools to determine comparability of biomedical results over time. This included Quality Control material, Quality Assurance Program material and patient means data from the pathology provider.
Patient means data
Patient means data are routinely used by pathology companies to inform comparability of their results over time (e.g. mean or median fasting plasma glucose levels for patients attending pathology clinics). Patient means data is based on individual test results and cannot distinguish individual people. Patient means data were extracted by the pathology provider for each test from their database for comparable time periods (2011–13, 2022–24) and included patient numbers, means, medians, and standard deviations of the tested pathology by age and sex. Patients who attended the pathology clinic for the purposes of the ABS collections were excluded from patient means analysis.
The numbers of data points available for tests included in standard pathology tests for individuals (such as cholesterol and haemoglobin) were much higher than those for tests which are usually only reported on special request by a health professional for an individual or recorded through studies of population health (such as sodium, potassium, and iodine). Results indicated that patient means data were not normally distributed. As patient means data cannot distinguish individual people, it cannot identify whether a person has been tested multiple times for medical reasons in the period assessed or only once.
In determining the comparability of results over time for each test, the patient means data should not be given the same weight by the user as the instrument verification and validation results, because the populations from which they were drawn were different in the two time periods assessed.
Changes in clinical practice
Over time, there have been changes in clinical practice and government health policy that may influence the type of clients attending pathology clinics. For example, the HbA1c test for diabetes is now used by health professionals to diagnose diabetes as well as to assess longer term management of diabetes (WHO 2019; D’Emden et al. 2012; Australian Diabetes Society 2015).
The age at which diabetes screening occurs has been lowered since 2011–13. For the general population, screening should now be every 3 years starting at age 40, and for people with obesity or other risk factors, screening should be every 3 years, not limited by age (RACGP 2016, 2020; Bell et al. 2020). For Aboriginal and Torres Strait Islander peoples, the screening age was initially lowered from that for the general population based on evidence from previous ABS biomedical surveys, but a more recent recommendation from the Royal Australian College of General Practitioners was for annual diabetes screening from 18 years of age and from 10 years of age for children with one or more risk factors (Burrow and Ride 2016; RACGP 2016, 2024; NACCHO 2024).
Recommendations for requesting a vitamin D test have also changed since 2011–13. The vitamin D test is currently not routinely recommended for adults, children or healthy infants, and there are criteria for eligibility for coverage of the cost of the test by the Pharmaceutical Benefits Scheme for ‘at risk’ groups (RACGP 2024).
Changes to clinical practice can impact the patient population used to derive quality metrics like patient means, but the impact on these data sets is unknown. In some cases, for example HbA1c and serum ferritin, changes in patient means data between the two time periods assessed were different in magnitude and direction for different age and sex groups. This indicates a potential change in client population rather than changes in results due to instrument or method upgrades.
Summary of changes
The tables below summarise changes in methods of analysis from 2011–13 to 2022–24, with comments on the equivalence of methods for consideration by users.
Group | Biomarker | Methods of analysis and instrumentation 2011–13 and 2022–24 | Review of equivalence of methods, instrumentation and patient means(a) |
---|---|---|---|
Cardiovascular disease biomarkers | Total cholesterol | 2011–13 and 2022–24 Cholesterol Oxidase (Architect Ci16200 instrument) | No change in method or instrument. |
High-density lipoprotein (HDL) cholesterol | 2011–13 and 2022–24 Enzymatic method plus accelerator selective detergent (Architect Ci16200 instrument) | No change in method or instrument. | |
Low-density lipoprotein (LDL) cholesterol | 2011–13 and 2022–24 Calculated using Friedwald equation from total cholesterol, HDL cholesterol and triglycerides results | No change in equation used. | |
Triglycerides | 2011–13 and 2022–24 Lipase glycerol kinase (GPO) (Architect Ci16200 instrument) | No change in method or instrument. | |
Diabetes biomarkers | Fasting plasma glucose (FPG) | 2011–13 2022–24 | No change in method. One instrument change. Validation studies demonstrate acceptable correlation between the two instruments. |
Glycated haemoglobin (HbA1c) | 2011–13 2022–24 | One method change. One instrument change. Pathology provider extensively evaluated the instrument and method changes. Studies demonstrated acceptable correlation for method and instrument changes. Patient means data indicate potential changes over time, where change varies in magnitude and direction for different age and sex groups. | |
Chronic kidney disease biomarkers | Albumin/creatinine ratio (ACR) | 2011–13 and 2022–24 ACR calculated by ratio of urinary albumin to urinary creatinine concentrations | No change in equation used. Correlation results for urinary creatinine were acceptable. See below for comments on urinary albumin test. |
Urinary albumin | 2011–13 2022–24 | No change in method. One instrument change. Pathology provider conducted correlation studies for change of instrument. The instrument change resulted in a positive bias in results for urinary albumin that may be reflected in observed changes in patient means data for the ACR between 2011–13 and 2021–22. Correlation results for urinary albumin were acceptable. | |
Urinary creatinine | 2011–13 2022–24 | No change in method. One instrument change. Studies demonstrate acceptable correlation between the two instruments. | |
Estimated glomerular filtration rate (eGFR) | 2011–13 and 2022–24 eGFR calculated using the CDK-EPI equations (race factor not included) | No change in equations used. | |
Serum creatinine | 2011–13 2022–24 | No change in method. One instrument change. Studies demonstrate acceptable correlation between the two instruments. | |
Liver function biomarkers | Alanine aminotransferase (ALT) | 2011–13 2022–24 | Change in method. New assay improves test sensitivity. No change in instrument. Studies demonstrate a difference in results and new reference intervals were adopted. Pathology provider notes the new activated ALT assay has a built-in intercept of -10 U/L. This can result in negative results being obtained in the 2022–24 National Biomedical Health Measures Study (routinely reported as <2 U/L). Time series comparison not possible. |
Gamma glutamyl transferase (GGT) | 2011–13 and 2022–24 Szasz l-gamma-glutamly-3-carboxyl-4-nitroanilide method (Architect Ci16200 instrument) | No change in method or instrument. Patient means data indicate potential changes over time. | |
Folate and vitamin B12 | Serum folate and serum vitamin B12 | 2011–13 2022–24 | No change in method. Two instrument changes. Instrument manufacturer provided correlation results for each instrument change (Roche Modular E170 to Cobas e601 to Cobas e801) and these were acceptable. No direct correlation study available between instruments used by pathology provider in 2011–13 and 2022–24. |
Iron biomarkers | Haemoglobin (Hb) | 2011–13 2022–24 | No change in method. One instrument change. Studies demonstrate acceptable correlation between the two instruments. |
Serum ferritin | 2011–13 and 2022–24 Chemiluminescent Microparticle Immunoassay (CMIA) method (Architect Ci16200 instrument) | No change in method or instrument. Patient means data indicate potential changes over time, where change varies in magnitude and direction for different age and sex groups. | |
C-reactive protein (CRP) | 2011–13 and 2022–24 Ultrasensitive immunoturbidimetric assay (Architect Ci16200 instrument) | No change in method or instrument. | |
Soluble transferrin receptor (sTfR) | 2011–13 2022–24 | Change in method. New assay implemented for new instrument. One instrument change. Pathology provider observed shift in distribution of results with the new sTfR assay from calibration studies. New reference intervals were developed to account for results shift. Time series comparison not possible. | |
Vitamin D | Vitamin D [Serum 25-hydroxyvitamin D, 25(OH)D] | 2011–13 and 2022–24 Liquid Chromatography with tandem mass spectrometry (LC-MS/MS instrument) | No change in method or instrument. |
Urinary ions | Iodine | 2011–13 2022–24 | No change in method. One instrument upgrade. Studies demonstrate acceptable correlation between the two instruments. Pathology provider notes the new model has improved sensitivity - results are reported in a slightly different way with additional information now included. This may be reflected in observed changes in patient means data for urinary iodine between 2011–13 and 2021–22, but the numbers of tests included in the patient means data were small as it is not a routine pathology test. |
Sodium and potassium | 2011–13 2022–24 | One method change. One instrument change. Pathology provider conducted correlation studies for change of instrument and method. The instrument change resulted in a negative bias in results for urinary sodium that may be reflected in observed changes in patient means data for urinary sodium between 2011–13 and 2021–22. Correlation results for urinary potassium were acceptable. |
a. Sonic Healthcare Australia Pathology provided biomedical testing services, through Douglass Hanly Moir Pathology, except for iodine which was tested by Sullivan Nicolaides Pathology.
Survey design changes
When comparing the 2011–13 and 2022–24 studies it is important to also consider impacts that changes to survey methodology may have on time series analysis. For more information, see the National Health Measures Survey methodology, 2022–24. Information on NATSIHMS 2022–24 will become available when first results are released.
References
Australian Diabetes Society (2015, updated 2023), Guidance concerning the use of glycated haemoglobin for the diagnosis of diabetes mellitus, Australian Diabetes Society, accessed 20/02/2025.
Bell K, Shaw JE, Maple-Brown L, Ferris W, Gray S, Murfet G, Flavel R, Maynard B, Ryrie H, Pritchard B, Freeman R, Gordan BA (2020), A position statement on screening and management of prediabetes in primary care in Australia, Diabetes Research and Clinical Practice, 164:108188, accessed 20/02/2025.
Burrow S, Ride K (2016), Review of diabetes among Aboriginal and Torres Strait Islander people, Australian Indigenous HealthInfoNet, accessed 20/02/2025.
d’Emden MC, Shaw JE, Colman PG, Colagiuri S, Twigg SM, Jones GRD, Goodall I, Schneider HG and Cheung NW (2012), The role of HbA1c in the diagnosis of diabetes mellitus in Australia, Medical Journal of Australia, 197(4):220-221, accessed 20/02/2025.
National Aboriginal Community Controlled Health Organisation (NACCHO) and The Royal Australian College of General Practitioners (RACGP) (2024), National guide to preventive healthcare for Aboriginal and Torres Strait Islander people: Recommendations. 4th edition., RACGP, accessed 20/02/2025.
Royal Australian College of General Practitioners (RACGP) and Diabetes Australia (2016), General practice management of type 2 diabetes: 2016–18 [PDF 3267 KB], RACGP, accessed 20/02/2025.
Royal Australian College of General Practitioners (RACGP) (2024), Management of type 2 diabetes: A handbook for general practice, RACGP, accessed 20/02/2025.
Royal Australian College of General Practitioners (RACGP) (2024), ‘Vitamin D testing’, First Do No Harm: a guide to choosing wisely in general practice, RACGP website, accessed 20/02/2025.
World Health Organization (WHO) (2019), Classification of diabetes mellitus, WHO, accessed 20/02/2025.