Educational Resources: D-100 Literature

Educational Resources
and References

Case Studies, Posters, and Performance Evaluations

  • lab techs holding blood sample
  • Hear from the A1c Experts

    Today's key opinion leaders in HbA1c testing can offer valuable insights and credible opinions about the benefits of the D-100 in their HbA1c testing. This is a collection of their comments, outcomes and experiences with the D-100 System excerpted from posters, published papers and performance evaluations.

  • Dr. Bernard Desprats

    A laboratory's perspective. Watch the video to learn why one of our customers chose the D-100 System.

Evaluations

Dr. Erna Lenters-Westra

How the D-100 System is Making World Class Diabetes Testing as Easy as A1c

"In general we can say that we have never worked with an instrument which is as easy to use as the D-100. Bio-Rad has really listened to the wishes of users with regards to ease of use of the instrument. The analytical performance of the D-100 is excellent."

Author

Dr. Erna Lenters-Westra
HbA1c Researcher, Klinisch Chemisch Laboratorium, Isala Zwolle, Netherlands

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Dr. Alain Pinet

Glycosylated haemoglobin with the D-100 from Bio-Rad: network innovation!

"Above all, I appreciate its analytical performance. In terms of reproducibility, I have moved to 0.6%! This leaves me a good margin to determine total error and wins over our trust in regard to renewing our certification."

Author

Dr. Alain Pinet
Sud-Ouest BIOmedica Laboratory Group, France

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Published Papers

Jaisson S et al.

Analytical performances of the D-100 hemoglobin testing system (Bio-Rad) for HbA1c assay

"The D-100 System exhibited good analytical performances for such a HbA1c assay, with improvements in terms of usability and ergonomics, making this system suitable for a routine practice clinical chemistry laboratories performing large HbA1c assay series."

Reference

Jaisson S et al. (2015). Analytical performances of the D-100 hemoglobin testing system (Bio-Rad) for HbA1c assay. Clin Chem Lab Med. Aug;53(9):1473-9.

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Herpol M et al.

Evaluation of the Sebia Capillarys 3 Tera and the Bio-Rad D-100 Systems for the Measurement of Hemoglobin A1c

"Startup time after shutdown of the system was 130 seconds. Results of two internal quality control (IQC) samples were available after 9minutes and 22 seconds. The first result of patient samples was available 2 minutes and 20 seconds after obtaining and verification of IQC results. The last result of 150 patient samples was available after 1 hour and 56 minutes. Of the 150 samples, 11 samples were re-run because of a "too low area" error code. The instrument was able to re-run automatically problematic samples."

Reference

Herpol M et al. (2016). Evaluation of the Sebia Capillarys 3 Tera and the Bio-Rad D-100 Systems for the Measurement of Hemoglobin A1c. Am J Clin Pathol. Jul;146(1):67-77.

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Degandt S et al.

Evaluation of four hemoglobin separation analyzers for hemoglobinopathy diagnosis

"The D-100 shows a low imprecision and a clinically acceptable correlation with other devices for HbF. Although the main objective of the D-100 is HbA1c analysis and not hemoglobinopathy analysis, thereby operating in a single mode, all tested Hb variants were detected and the most common ones (Hb C, D, E and S) were correctly identified."

Reference

Degandt S et al. (2018). Evaluation of four hemoglobin separation analyzers for hemoglobinopathy diagnosis. Am J Clin Lab Anal. Jan;32(1).

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EurA1c Trial Group IFCC C-EUBD

EurA1c: The European HbA1c Trial to Investigate the Performance of HbA1c Assays in 2166 Laboratories across 17 Countries and 24 Manufacturers by Use of the IFCC Model for Quality Targets

"Fresh whole blood (WB) and lyophilized hemolysate (LH) specimens manufactured from the same pool were used by 17 external quality assessment organizers to evaluate analytical performance of 2166 laboratories. Results were evaluated per country, per manufacturer, and per manufacturer and country combined according to criteria of the IFCC model for quality targets. Excellent performance is seen with WB (A) and LH (D-100)."

Reference

EurA1c Trial Group IFCC C-EUBD (2018) EurA1c: The European HbA1c Trial to Investigate the Performance of HbA1c Assays in 2166 Laboratories across 17 Countries and 24 Manufacturers by Use of the IFCC Model for Quality Targets. Clin Chem. Aug;64(8):1183-1192.

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Maesa JM et al.

Evaluation of Bio-Rad D-100 HbA1c analyzer against Tosoh G8 and Menarini HA-8180V

"Finally, D-100 provides a number of advantages in daily operation such as the incorporation of computer and control software on the instrument itself, controlled through an easy-to-use touch screen. Through the screen the operator has access to all system controls and configurations; maintenance procedures, change of reagents, performance of analyses, data collection and inspection of chromatograms. The change of reagents, column and pre-filter is very simple and can be done with the equipment running, it not being necessary to change the column for up to 10,000 determinations. Also an excellent throughput should be noted allowing the achievement of only 45 seconds per determination, which is better than the throughput of the G8 and HA-8180V."

Reference

Maesa JM et al. (2016). Evaluation of Bio-Rad D-100 HbA1c analyzer against Tosoh G8 and Menarini HA-8180V. Pract Lab Med. Aug 1; 5: 57-64.

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Liu C et al.

Analytical Performance of Bio-Rad D-100 on a Hemoglobin A1c Assay

"The D-100 System showed reliable analytical performance with good precision and linearity, minimal carry-over, and acceptable comparative characteristics relative to other instruments. D-100 is expected to be useful for clinical measurements of HbA1c for diabetes diagnosis and theranostics."

Reference

Liu C et al. (2017). Analytical Performance of Bio-Rad D-100 on a Hemoglobin A1c Assay. Lab Med Online. Apr;7(2):59-65.

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Rohlfing C et al.

Effects of hemoglobin C, D, E and S traits on measurements of hemoglobin A1c by twelve methods

"The D-100 System exhibited good analytical performances for such a HbA1c assay, with improvements in terms of usability and ergonomics, making this system suitable for a routine practice clinical chemistry laboratories performing large HbA1c assay series."

Reference

Jaisson S et al. (2015). Analytical performances of the D-100 hemoglobin testing system (Bio-Rad) for HbA1c assay. Clin Chem Lab Med. Aug;53(9):1473-9.

View Publication

 

Posters

White-Al Habeeb N et al.

Evaluation of the Bio-Rad D-100 system for the measurement of glycated hemoglobin (HbA1c)

"The Bio-Rad D-100 System performed well and met the evaluation criteria for the measurement of HbA1c using both quality control materials (Bio-Rad Lyphochek and Liquichek) and patient samples. The D-100 met linearity and accuracy assessments using survey materials from IQMH and CAP."

Authors

White-Al Habeeb N, Dong H, Cheng PL, Youkhana S, Lam S, Rohlfing C, Little R, Yip P

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Etchells B and Candelaria WJ

Evaluation of the Bio-Rad D-100 Hemoglobin Testing System

"The performance of the Bio-Rad D-100 met all of the manufacturers stated claims. The D-100 Hemoglobin Testing System produces an HbA1c in just 45 seconds without interference from common hemoglobin variants and HbF up to 30%. With an 80 test hourly throughput and a 10,000 sample analytical column, the system meets the needs of high volume laboratories. The D-100 also maximizes workflow efficiency. Onboard Advisor software rules simplify chromatogram interpretation. We found that it provides a consistent and thorough review of every result. Normal results may be released automatically to the LIS, while flagged results are held for further review. This ensures nothing is missed while dramatically reducing hands-on time. With the built-in result review criteria and the bi-directional LIS interface, >90% of our patient samples are run and verified with no tech intervention. The consumables use RFID technology and buffer can be changed while the system is running."

Authors

Etchells B and Candelaria WJ

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Paleari R et al.

Evaluation of the D-100 HPLC System for the Determination of Glycated Hemoglobin

"The Bio-Rad D-100 System is a fully automated, user-friendly, high throughput HPLC system giving accurate and reproducible results. The system showed a reduced hands-on time, simple calibration process, a very good workflow efficiency thanks to the intuitive interface, and an high speed HbA1c assay in 45 seconds. D-100 therefore displays the appropriate characteristics to be used as a routine method in clinical laboratories."

Authors

Paleari R, Saibene D, Moia R, Besozzi M, Varini M, Pezzo M, Ceriotti F, Mosca A

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Brugnolo L et al.

Determination of Glycated Haemoglobin: Assessment of the Bio-Rad D-100 Instrument

"The D-100 analytical performance, both in terms of precision, accuracy and correlation with the method in use, proved to be very satisfactory. The most common haemoglobin variants studied (HbS, HbC HbD, HbE) are automatically identified by the software and did not demonstrate analytical interference with HbA1c measurement. The ease of use, robustness and hourly productivity attest to the possible application in clinical laboratory diagnostics."

Authors

Brugnolo L, Artusi C, Marinova M, Zaninotto M, Plebani M

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Brugnolo L et al.

Lean-Six Sigma Applied to HbA1c Testing: Organisational Impact of the D-100 System

"The D-100 Hemoglobin Testing System, generally emits a very low daily quantity of waste (less than 1 liter for the routine of 200 samples), thus optimizing overall disposal costs. Reagents and calibrators are automatically recognized by the system, traced in the software and stored in the archive. Also, calibration curves are stored in such a way that for each sample performed it is always possible to trace, even after a long period of time, the batch of reagents and the calibration curve used. The D-100 Hemoglobin Testing System is reliable, with a clinical risk calculated, based on the checks performed, practically zero with E(Nuf) < 1 and E(Nuc) < 1. The analytical performance of the D-100 Hemoglobin Testing System associated with Mission Control would allow the laboratory to streamline quality control management resources for glycated hemoglobin testing."

Authors

Brugnolo L, Artusi C, Marinova M, Zaninotto M, Plebani M

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