Evaluation of a dual hemoglobin A(2)/A(1c) quantitation kit on the bio-rad variant II automated hemoglobin analyzer.

CONTEXT

Quantitation of hemoglobin (Hb) A(1c) and investigation of hemoglobinopathy on the Bio-Rad Variant analyzers require a switch between 2 separate kits that is time consuming and causes errors.

OBJECTIVE

Evaluation of a new Variant II HbA(2)/HbA(1c) Dual kit capable of both Hb A(1c) quantitation and hemoglobinopathy investigation on a single kit.

DESIGN

We evaluated Hb A(1c), Hb A(2), and Hb F quantitation for precision, linearity, and correlation with current methodology. We also evaluated detection of Hb variants and correlation of Hb Barts quantitation.

SETTING

Hamilton Regional Laboratory Medicine Program, Provincial Hemoglobinopathy Laboratory, St Joseph's Healthcare Site, Hamilton, Ontario.

PATIENTS

Patient blood samples submitted for Hb A(1c) quantitation or hemoglobinopathy investigation.

MAIN OUTCOME MEASURES

Precision, linearity, linear regression, and reference interval validation.

RESULTS

We provide tables and figures illustrating precision, linearity, linear regression, and quantitation of Hb variants. We validated reference intervals for Hb A(1c), Hb A(2), and Hb F.

CONCLUSIONS

The dual kit provides precise Hb A(1c), Hb A(2), and Hb F quantitation. The results show good linearity and correlate well with the results of current methods. We detected all clinically important Hb variants and a wide variety of rare variants. The dual kit has several advantages: it eliminates the need for extensive kit switch over; improves utility for newborn screening because of its quantification of Hb Barts; permits quantification of Hb A(1c) using the beta-Thal method; and eliminates the need for separate Hb A(2) reference intervals for patients with Hb S because of its accurate quantitation of Hb A(2) in the presence of Hb S.