Validation & methodology

Our method.

What we measure, how we measure it, and the published research that makes the result trustworthy enough for your GP to act on. TGA-registered kit (ARTG 526367), made in Australia.

Reading this because you've heard at-home tests aren't accurate? Read the honest answer first.
Licensed Omega-3 Index Methodology

The original Omega-3 Index methodology, delivered in Australia.

We're the only laboratory in Asia-Pacific licensed to deliver the Omega-3 Index using the original methodology defined by Harris & von Schacky (2004) in their landmark Preventive Medicine paper. Your result sits on the same internationally-recognised reference scale used in the 450+ peer-reviewed publications that cite the Omega-3 Index, including the published trials underpinning international clinical guidelines.

A reference-laboratory method, delivered at home.

Fatty acid analysis has historically been done in research labs and specialised clinical reference labs. The reason is methodological: doing it well requires gas chromatography with flame ionisation detection (GC-FID) — the reference method for fatty acid analysis. It separates and quantifies individual fatty acids with high precision, which immunoassay-based testing cannot do.

Our partner laboratory uses GC-FID to quantify 24 individual fatty acids from your dried blood spot sample — the same method used in the published omega-3 trials underpinning international clinical guidelines. Combined with the dried blood spot (DBS) collection format — samples are stable on the card for several weeks at room temperature — we can deliver research-grade analytical quality through the post.

What we measure

Omega-3 Index Basic

EPA + DHA expressed as a percentage of total identified fatty acids. First proposed by Harris and von Schacky (2004) as a more biologically meaningful measure of omega-3 status than serum or plasma levels. Dried blood spot results show strong correlation (R² > 0.96) with the gold-standard RBC-membrane Omega-3 Index, reflecting your omega-3 intake over the previous 3-4 months.

Reference range: 2.8–15.4%. Optimal: 8–12%. Reference ranges encompass 99% of fatty acid levels measured in adult populations.

Omega-3 Plus Ratios

Everything in the Index, plus the omega-6 : omega-3 ratio (a marker of overall dietary fat balance) and the arachidonic acid (AA) : EPA ratio (a more specific inflammatory-balance marker). A typical Western diet produces ratios in the 10:1 to 20:1 range; published research suggests 4:1 or lower may be more favourable for inflammatory health.

Omega-3 Complete

The full panel of 24 individual fatty acids across the omega-3 family (EPA, DHA, DPA, ALA), omega-6 family (linoleic acid, arachidonic acid, GLA, others), plus saturated, monounsaturated, and trans fats. The same breadth typically reported in clinical research studies of fatty acid status.

Prenatal Omega-3

DHA expressed as a percentage of total identified fatty acids, with reference ranges tuned for pregnancy. The same analyte and methodology used in the SAHMRI Test-and-Treat Program.

We report this as the Prenatal DHA Index — DHA as a percentage of total identified fatty acids.

Pregnancy reference range: 2.2–8.7%. Optimal in pregnancy: 4.9–8.0%. Categories: Low (<2.2%), Suboptimal (2.2–4.9%), Optimal (4.9–8.0%), Elevated (>8.0%).

Why the dried blood spot method works

The DBS sample type has been validated for fatty acid analysis in multiple published studies. Fatty acids in the dried sample are stable for several weeks at room temperature — which is the entire reason this can be a postal product. Compared to a venous draw, you lose nothing in analytical quality, and you gain at-home collection, no fasting requirement, no temperature-controlled shipping, and no clinic visit.

For the Omega-3 Index specifically, the DBS measurement shows R² > 0.96 correlation with the RBC-membrane-based reference method — meaning the two are statistically interchangeable for clinical purposes.

For practitioners. The full method validation document and quality assurance summary are available on request. Email info@omega3index.com.au.

Method specifications

Sample type Dried blood spot (DBS) on collection card
Volume required ~50–100 μL per spot (one finger-prick fills two spots)
Method Gas chromatography with flame ionisation detection (GC-FID)
Analytes quantified 24 fatty acids across omega-3, omega-6, saturated, monounsaturated, and trans fat families
Sample stability Several weeks at room temperature on the card
Reportable units Percentage of total identified fatty acids
Turnaround time 3–5 business days from lab receipt
QC Automated checks against validated ranges; out-of-range results reviewed by a qualified scientist before release
Kit regulatory status TGA Class IIa Medical Device, ARTG 526367
Methodology licence Licensed Omega-3 Index methodology (Harris & von Schacky 2004); first Australian, only Asia-Pacific lab

Quality assurance

TGA registration. Our test kit is registered on the Australian Register of Therapeutic Goods as a Class IIa Medical Device (ARTG 526367), manufactured in Australia at Suite 2080, 112 Snell Grove, Oak Park VIC 3046.

Internal QC on every batch. Every analytical run includes blank controls, calibrators across the full dynamic range, and quality-control material at multiple concentrations. Out-of-range patient results trigger automatic technical review before report release.

Internal standards on every sample. Calibrated internal standards are added to every sample. This corrects for sample-to-sample variation in extraction recovery and detection response, producing results that are quantitatively accurate rather than just relatively comparable.

Selected references

  1. Harris WS, von Schacky C. The Omega-3 Index: a new risk factor for death from coronary heart disease? Preventive Medicine. 2004;39(1):212-220.
  2. Makrides M, Gibson RA, McPhee AJ, et al. Effect of DHA supplementation during pregnancy on depression and neurodevelopment of young children (DOMInO Trial). JAMA. 2010;304(15):1675-1683.
  3. Middleton P, Gomersall JC, Gould JF, et al. Omega-3 fatty acid addition during pregnancy. Cochrane Database of Systematic Reviews. 2018;11:CD003402.
  4. Makrides M, Best K, Yelland L, et al. A Randomized Trial of Prenatal n-3 Fatty Acid Supplementation and Preterm Delivery (ORIP Trial, n=5,517). NEJM. 2019;381:1035-1045.
  5. Simmonds LA, Sullivan TR, Skubisz M, et al. Omega-3 fatty acid supplementation in pregnancy — baseline omega-3 status and early preterm birth. BJOG. 2020;127(8):975-981.
  6. Best KP, Gibson RA, Makrides M. ISSFAL statement number 7 — Omega-3 fatty acids during pregnancy to reduce preterm birth. Prostaglandins Leukot Essent Fatty Acids. 2022;186:102495.
  7. Best KP, Northcott C, Simmonds LA, et al. Feasibility, Implementation and Early Adoption of an Omega-3 Test-and-Treat Program. MJA. 2025.