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Report on HbA1c Proficiency Testing in Asia in 2012.

Umemoto M, Hoshino T, Miyashita T, Tani W, Kuwa K - Ann Lab Med (2015)

Bottom Line: The participated measurement systems were NGSP certified.The combination plots of the bias data in this PT and in the NGSP certification performed in March and May in 2012 were consistent with each other: mean NGSP values at each level agreed well with the target value.In conclusion, PT using whole blood is useful in endorsing NGSP certification.

View Article: PubMed Central - PubMed

Affiliation: Reference Material Institute for Clinical Chemistry Standards, Kanagawa, Japan.

ABSTRACT
In 2010, the Japan Diabetes Society decided to introduce the National Glycohemoglobin Standardization Program (NGSP) values into clinical practice. Accordingly, NGSP Certification of Japanese manufacturers of HbA1c-related diagnostic reagents and instruments was initiated in February, 2012, through an NGSP network laboratory, the Asian Secondary Reference Laboratory (ASRL) #1. Traceability to the NGSP reference system can be endorsed by manufacturer certification, as well as by the College of American Pathologists (CAP) survey. Nevertheless, only a few manufacturers participate in the CAP survey in Japan. Thus, proficiency testing (PT) was proposed and executed by ASRL #1. Single-donor whole-blood samples were used for the PT. The participated measurement systems were NGSP certified. Twenty-two laboratories obtained certification through ASRL #1; 2 through the Secondary Reference Laboratory (SRL) #8; and 9 through the SRL #9. The combination plots of the bias data in this PT and in the NGSP certification performed in March and May in 2012 were consistent with each other: mean NGSP values at each level agreed well with the target value. In conclusion, PT using whole blood is useful in endorsing NGSP certification.

No MeSH data available.


Related in: MedlinePlus

Observed HbA1c values of each participating laboratory compared to the NGSP/ASRL target (dashed line) in 2012 based on ASRL PT data. Closed circles show within ±5% (dotted line) of relative bias. Open circles show within ±7% (dashed line) of relative bias. Open squares show biases of all manufacturers versus ASRL target PT samples.Abbreviations: NGSP, National Glycohemoglobin Standardization Program; ASRL, Asian Secondary Reference Laboratory; PT, proficiency testing.
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Figure 1: Observed HbA1c values of each participating laboratory compared to the NGSP/ASRL target (dashed line) in 2012 based on ASRL PT data. Closed circles show within ±5% (dotted line) of relative bias. Open circles show within ±7% (dashed line) of relative bias. Open squares show biases of all manufacturers versus ASRL target PT samples.Abbreviations: NGSP, National Glycohemoglobin Standardization Program; ASRL, Asian Secondary Reference Laboratory; PT, proficiency testing.

Mentions: Compatibility with JDS criteria (less than or equal to a relative bias of ±5.0% by mean of duplicate measurement) was checked by comparing the measured values of test samples 1 through 3 for the certification of 5% to10.0% HbA1c. The results indicate that 26 out of 28 methods in test sample 1, 26 out of 28 in test sample 2, and 26 out of 27 in test sample 3 were compatible with JDS criteria [1]. Fig. 1 shows combination plots of bias data in this study and bias data from NGSP certification through ASRL #1 conducted during March and May, 2012. Bias plots of mean values versus target values of PT samples in this report are also shown for comparison, and they are in good agreement with each other.


Report on HbA1c Proficiency Testing in Asia in 2012.

Umemoto M, Hoshino T, Miyashita T, Tani W, Kuwa K - Ann Lab Med (2015)

Observed HbA1c values of each participating laboratory compared to the NGSP/ASRL target (dashed line) in 2012 based on ASRL PT data. Closed circles show within ±5% (dotted line) of relative bias. Open circles show within ±7% (dashed line) of relative bias. Open squares show biases of all manufacturers versus ASRL target PT samples.Abbreviations: NGSP, National Glycohemoglobin Standardization Program; ASRL, Asian Secondary Reference Laboratory; PT, proficiency testing.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4390705&req=5

Figure 1: Observed HbA1c values of each participating laboratory compared to the NGSP/ASRL target (dashed line) in 2012 based on ASRL PT data. Closed circles show within ±5% (dotted line) of relative bias. Open circles show within ±7% (dashed line) of relative bias. Open squares show biases of all manufacturers versus ASRL target PT samples.Abbreviations: NGSP, National Glycohemoglobin Standardization Program; ASRL, Asian Secondary Reference Laboratory; PT, proficiency testing.
Mentions: Compatibility with JDS criteria (less than or equal to a relative bias of ±5.0% by mean of duplicate measurement) was checked by comparing the measured values of test samples 1 through 3 for the certification of 5% to10.0% HbA1c. The results indicate that 26 out of 28 methods in test sample 1, 26 out of 28 in test sample 2, and 26 out of 27 in test sample 3 were compatible with JDS criteria [1]. Fig. 1 shows combination plots of bias data in this study and bias data from NGSP certification through ASRL #1 conducted during March and May, 2012. Bias plots of mean values versus target values of PT samples in this report are also shown for comparison, and they are in good agreement with each other.

Bottom Line: The participated measurement systems were NGSP certified.The combination plots of the bias data in this PT and in the NGSP certification performed in March and May in 2012 were consistent with each other: mean NGSP values at each level agreed well with the target value.In conclusion, PT using whole blood is useful in endorsing NGSP certification.

View Article: PubMed Central - PubMed

Affiliation: Reference Material Institute for Clinical Chemistry Standards, Kanagawa, Japan.

ABSTRACT
In 2010, the Japan Diabetes Society decided to introduce the National Glycohemoglobin Standardization Program (NGSP) values into clinical practice. Accordingly, NGSP Certification of Japanese manufacturers of HbA1c-related diagnostic reagents and instruments was initiated in February, 2012, through an NGSP network laboratory, the Asian Secondary Reference Laboratory (ASRL) #1. Traceability to the NGSP reference system can be endorsed by manufacturer certification, as well as by the College of American Pathologists (CAP) survey. Nevertheless, only a few manufacturers participate in the CAP survey in Japan. Thus, proficiency testing (PT) was proposed and executed by ASRL #1. Single-donor whole-blood samples were used for the PT. The participated measurement systems were NGSP certified. Twenty-two laboratories obtained certification through ASRL #1; 2 through the Secondary Reference Laboratory (SRL) #8; and 9 through the SRL #9. The combination plots of the bias data in this PT and in the NGSP certification performed in March and May in 2012 were consistent with each other: mean NGSP values at each level agreed well with the target value. In conclusion, PT using whole blood is useful in endorsing NGSP certification.

No MeSH data available.


Related in: MedlinePlus