What does this research mean for the field?

Enzymatic assays for HbA1c measurement demonstrate strong correlation and agreement with the gold standard HPLC method, despite slightly lower diagnostic accuracy in pre-diabetic and diabetic ranges. Novelty: ClaimNovelty.CONFIRMATORY. Consensus alignment: ConsensusAlignment.NEUTRAL.

What question did this study set out to answer?

To evaluate the concordance, diagnostic accuracy, and agreement between an enzymatic assay and gold-standard high performance liquid chromatography (HPLC) for blood HbA1c measurement.

August 22, 2026Scientific ReportsOpen Access

Comparative analysis of enzymatic assay for HbA1c measurement with high performance liquid chromatography

Q: What is the clinical evidence from this study?

Study design: Cross-Sectional. Population: Diabetes (n=1014). Intervention: Enzymatic assay (EA) vs. High Performance Liquid Chromatography (HPLC). Primary outcome: Concordance and agreement of HbA1c levels (r = 0.97).

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Key result

Enzymatic HbA1c assay shows strong agreement with HPLC, yielding a ~0.97 correlation.

r = 0.97
n=1,014

Why the study?

Does enzymatic assay provide comparable HbA1c measurements to high performance liquid chromatography in a general population?

Population

1014 participants regardless of age, gender and type of diabetes, mean age 53.49 ± 13.94 years, 50.89%…

Comparison

HbA1c measurement using enzymatic assay (EA) vs HbA1c measurement using High Performance Liquid…

Design

Cross-sectional

Authors

GRGulab Fatima RaniKhyber Medical University HBHazrat BilalKhyber Teaching Hospital SJShumaila JabeenKhyber Teaching Hospital

Discussion

Member takes

Implication

Enzymatic assays for HbA1c measurement show strong correlation and agreement with the gold standard HPLC method, supporting their clinical utility.

Key Points

To evaluate the concordance, diagnostic accuracy, and agreement between an enzymatic assay and gold-standard high performance liquid chromatography (HPLC) for blood HbA1c measurement.
Analyzed blood samples from 1,014 participants (mean age 53.49 ± 13.94 years; 50.89% female) across normal, pre-diabetic, and diabetic glycemic ranges.
Measured HbA1c levels using both enzymatic assays and HPLC protocols according to manufacturer standard operating procedures.
Assessed method comparison using Pearson's correlation coefficient, linear regression, Bland-Altman agreement analysis, and diagnostic accuracy indices.
Demonstrated a strong positive overall correlation between HPLC and enzymatic assay measurements (r = 0.97), with mean differences falling within acceptable bias limits on Bland-Altman analysis.
Identified strong correlation in diabetic samples, but correlation weakened to moderate and weak levels in pre-diabetic and non-diabetic subgroups.
Showed slightly lower diagnostic accuracy metrics for the enzymatic assay in pre-diabetic and diabetic HbA1c threshold ranges.

Study Design

Type

Cross-Sectional (n=1,014)

Structured PICO

Does enzymatic assay provide comparable HbA1c measurements to high performance liquid chromatography in a general population?

Population

1,014 participants with a mean age of 53.5 years (50.9% female) evaluated for HbA1c levels regardless of diabetes type.

Exposure

HbA1c measurement using enzymatic assay (EA)

Comparator

HbA1c measurement using High Performance Liquid Chromatography (HPLC)

Outcome

Concordance and agreement between HbA1c levels measured by HPLC and EAsurrogate

Main Result

Effect estimate: r = 0.97

Enzymatic assays for HbA1c measurement show strong correlation and agreement with the gold standard HPLC method, supporting their clinical utility.

Limitations

Need for further studies comparing pre-diabetic HbA1c range between assays while taking interference factors into account
Lack of comparison of pre-diabetic HbA1c range taking interference factors into account

Cite This Study

Rani et al. (2026) conducted a cross-sectional in Diabetes (n=1,014). Enzymatic assay (EA) vs. High Performance Liquid Chromatography (HPLC) was evaluated on Concordance and agreement of HbA1c levels (r = 0.97). Enzymatic assay for HbA1c measurement showed a strong association and agreement with High Performance Liquid Chromatography, demonstrating an overall correlation coefficient of 0.97.

synapsesocial.com/papers/6a895ec3ca7ade938187cd6d https://doi.org/10.1038/s41598-025-07872-z

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Implication

Enzymatic assays for HbA1c measurement show strong correlation and agreement with the gold standard HPLC method, supporting their clinical utility.

Comparative analysis of enzymatic assay for HbA1c measurement with high performance liquid chromatography

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Main Result

Limitations

Cite This Study

Comparative analysis of enzymatic assay for HbA1c measurement with high performance liquid chromatography

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Main Result

Limitations

Cite This Study

Also Consider

Also Consider