Accuracy that adds up
Optilite IgG subclass assays uniquely use a single international calibrant (ERM-DA470k) for both total IgG and subclasses, supporting:
- Reliable subclass summation
- Accurate biological distribution (IgG1 > IgG2 > IgG3 > IgG4)
- Consistent, reliable reporting for laboratories
Carvalho et al.1 reported:
"that the Immunoturbidimetry assay appears to be the most reliable to evaluate IgG Subclasses: the sum of IgG Subclasses and Total IgG correlate better than by Nephelometry."
Adapted from Carvalho et al. 20241
Read more about the superior performance of Optilite IgG subclass assays
Leaders in special protein testing
With over 40 years of protein diagnostics expertise, Binding Site’s IgG subclass assays are routinely used in more than 60 countries. Built on international reference alignment and proven assay performance, they deliver accurate, traceable results clinicians rely on.
- Supported by independent publications confirming analytical reliability1,2,3
- IgG4 measurement recognised in the 2020 Revised Comprehensive Diagnostic Criteria for IgG4-Related Disease4
- The 1.35 g/L diagnostic cut-off was established using Binding Site reagents and confirmed in multicentre studies5
- Usami et al.6 stated: “The IgG4 value measured using the TBS reagent is an accurate value.”2,3
Optilite assays combines scientific heritage with innovation — providing the accuracy and confidence laboratories need for every result.
Convenience with every test
The Optilite analyser delivers reliable performance and efficient workflows for every IgG subclass test. With onboard cooling, automated dilution management, long open vial stability and minimal operator intervention, laboratories can work with confidence and consistency.
Key benefits:
- Reduced waste and cost-effective reagent management
- Enhanced daily workflow
- Improved efficiency with fewer interruptions
- Faster turnaround times
- Reliable result reporting
Download the brochure to learn how the Optilite IgG subclass assays bring confidence, accuracy, and convenience to every test
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References
- Carvalho – Nephelometry vs. Immunoturbidity assay: Analytical performance on IgG subclasses, J Immunol Methods 2024
- Ladwig PM, Barnidge DR, Snyder MR, Katzmann JA, Murray DL. Quantification of serum IgG subclasses by use of subclass-specific tryptic peptides and liquid chromatography–tandem mass spectrometry. Clin Chem. 2014;60(8):1080-1088. doi:10.1373/clinchem.2014.222208
- Bernasconi L, Mundwiler-Pachlatko E, Regenass S, Aubert V, Hammerer-Lercher A, Heijnen I. Variable and inaccurate serum IgG4 levels resulting from lack of standardization in IgG subclass assay calibration. Clin Chem Lab Med. 2019;57(11):1777-1783. doi:10.1515/cclm-2019-0261
- H. Umehara, K. Okazaki, S. Kawa, H. Takahashi, H. Goto, S. Matsui, N. Ishizaka, T. Akamizu, Y. Sato, M. Kawano, the Research Program for Intractable Disease by the Ministry of Health, Labor and Welfare (MHLW) Japan., The 2020 revised comprehensive diagnostic (RCD) criteria for IgG4-RD, Modern Rheumatology 2021; 31: 529–533
- Hamano H, Kawa S, Horiuchi A, et al. High serum IgG4 concentrations in patients with sclerosing pancreatitis. N Engl J Med 2001; 344:732–738.
- Usami et al. Cut-off values of serum IgG4 among three reagents, including a novel IgG4 reagent: a multicenter study. Sci Rep. 2021 Mar 31;11(1):7280.