College of American Pathologists (CAP) GH5 Survey Data:

(updated 12/19)
The American Diabetes Association (ADA) recommends that “The A1C test should be performed using a
method that is certified by the NGSP”. All laboratories performing HbA1c testing should participate in a fresh
sample proficiency testing survey such as the College of American Pathologists (CAP). CAP GH5 data for the
third survey of 2019 are summarized below. The NGSP target or reference values are based on replicate
analyses using eight NGSP certified secondary reference methods.

Commentary by R. Little, Ph.D., NGSP Network Coordinator for the NGSP Steering Committee
Beginning in 2015 there are two CAP programs for HbA1c proficiency testing using fresh whole blood
samples - GH2 and GH5. GH2 samples are shipped twice a year with three samples in each mailing as
before. GH5 are shipped three times a year with five samples in each mailing. The three samples in each
of the two GH2 mailings are also included in two of the GH5 mailings. Therefore the NGSP follows the
three GH5 surveys which include all the samples used for both surveys.
In 2019, based on data from the GH5-C survey:
 Bias from the NGSP target and variability (±2SD) are shown in Table 1 and in figure 1 (Figure 1
graphs in order by HbA1c level) for each method. The shaded rectangle (fig 1) reflects the current
CAP acceptance limit of ±6.
 The absolute mean bias for each method group ranged from 0.00 to 0.34% HbA1c. There were two
methods with a bias > 0.30% HbA1c for the sample with the highest HbA1c (Siemens Dimension
Vista and Tosoh G8).
 Method-specific, between-laboratory CV’s ranged from 0.8% to 4.0%. The Beckman AU HbA1c
Advanced and the Beckman AU Systems each had a CV over 3.5% for 1/3 and 2/5 samples,
respectively. There were six methods with CVs ≤2% for 5/5 samples– the Abbott Alinity ci series,
Abbott Architect c, Arkray Adams HA-8180, Roche cobas c513, Sebia Capillarys 2 FP and Tosoh G8.
Approximately 88% of laboratories are using methods with between-lab CVs <3% at all five HbA1c
levels; approximately 97% of laboratories are using methods with CVs <3.5% at all five HbA1c levels.
 The current pass limit for the GH5 survey is ±6%. The overall pass rates in this survey were 97.0,
97.1, 97.9, 97.5 and 96.4% for samples GH-11 through GH-15, respectively. For individual methods,
the lowest pass rate was 85.0% and the highest was 100%. The overall pass rates with a pass limit of
±5% were 93.4% to 97.5%. As expected, methods with small bias and low CVs will have the highest
pass rates and, conversely, methods with large bias and/or high CVs will have the lowest pass rates.
 The overall CVs for the last 25 surveys are shown in Table 2. All-method CVs for the current survey
were <3.0%.
 Laboratories should avoid using methods with high CVs and/or consistent high bias.

NOTE: The NGSP certification evaluates agreement of each method at the manufacturing site using one lot
of reagents and calibrators, one instrument, and one application under optimal conditions. CAP precision
reflects between-laboratory reproducibility, often with more than one lot of reagents and calibrators, and
sometimes with different instruments (e.g. Siemens Advia instruments) and/or different applications (e.g.
with or without sample pretreatment). In addition, if changes were made in the method just prior to NGSP
certification, it is possible that not all participating laboratories in the field would have made the change at
the time of the CAP survey. For these reasons, it is important that laboratories review not only the
certification status of HbA1c methods but also their performance in the CAP survey over time (a good
indication of field performance) when selecting or evaluating HbA1c assay methods.

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TABLE 1: 2019 GH5-C
GH5-11 GH5-12 GH5-13 GH5-14 GH5-15

NGSP %HbA1c Reference Value (95% CI) 5.25 (5.21-5.29) 6.41 (6.37-6.46) 8.21 (8.17-8.26) 5.47 (5.43-5.51) 9.48 (9.43-9.52)

Mean % Mean % Mean % Mean % Mean %

no. labs Mean bias Mean bias Mean bias Mean bias Mean bias
%HbA1c CV %HbA1c CV %HbA1c CV %HbA1c CV %HbA1c CV
Abbott Alinity ci series 18 5.13 -0.12 1.7 6.34 -0.07 1.5 8.32 0.11 0.8 5.41 -0.06 1.4 9.62 0.14 0.9

Abbott Architect c System 234 5.14 -0.11 1.6 6.37 -0.04 1.6 8.35 0.14 1.3 5.40 -0.07 1.4 9.66 0.18 1.2

Alere Afinion 2 22 5.20 -0.05 2.6 6.38 -0.03 2.7 8.15 -0.06 2.1

Alere Afinion AS100 136 5.11 -0.14 1.7 6.23 -0.18 2.0 8.14 -0.07 1.7 5.30 -0.17 2.1 9.38 -0.10 1.6
ARKRAY Adams HA-8180
22 5.26 0.01 1.4 6.47 0.06 1.2 8.25 0.04 1.5 5.53 0.06 1.3 9.54 0.06 1.6
series
Beckman AU HbA1c Advanced 10 5.23 -0.02 2.6 6.40 -0.01 3.7
Beckman AU Systems -
78 5.20 -0.05 3.0 6.41 0.00 2.7 8.07 -0.14 3.8 5.42 -0.05 3.0 9.30 -0.18 4.0
Beckman reagent
Beckman UniCel DxC Synchron
81 5.24 -0.01 3.0 6.32 -0.09 2.6 8.08 -0.13 2.2 5.39 -0.08 2.7 9.39 -0.09 3.1
Systems
Bio-Rad D-10 135 5.17 -0.08 2.4 6.51 0.10 2.1 8.16 -0.05 2.1 5.44 -0.03 2.2 9.58 0.10 1.9

Bio-Rad D-100 119 4.99 -0.26 2.3 6.27 -0.14 2.1 7.95 -0.26 2.0 5.26 -0.21 2.2 9.27 -0.21 2.1

Bio-Rad Variant II 21 5.16 -0.09 3.4 6.49 0.08 2.7 8.34 0.13 1.9 5.40 -0.07 2.9 9.64 0.16 2.7

Bio-Rad Variant II Turbo 29 5.06 -0.19 2.7 6.42 0.01 1.9 8.19 -0.02 1.7 5.31 -0.16 2.0 9.53 0.05 1.7

Bio-Rad Variant II Turbo 2.0 131 5.05 -0.20 2.7 6.41 0.00 1.9 8.19 -0.02 1.8 5.33 -0.14 2.4 9.52 0.04 1.7

Roche cobas c311 21 5.14 -0.11 2.6 6.35 -0.06 2.2 8.31 0.10 2.3 5.34 -0.13 2.7 9.75 0.27 1.4

Roche cobas c500 series 406 5.18 -0.07 2.3 6.42 0.01 2.4 8.32 0.11 2.3 5.43 -0.04 2.2 9.57 0.09 2.3

Roche cobas c513 59 5.21 -0.04 1.6 6.41 0.00 1.7 8.24 0.03 1.9 5.43 -0.04 1.5 9.57 0.09 1.9

Roche COBAS Integra 400 41 5.17 -0.08 2.4 6.36 -0.05 1.9 8.33 0.12 2.1 5.46 -0.01 1.9 9.54 0.06 1.6

Sebia Capillarys 2 Flex Piercing 67 5.18 -0.07 1.8 6.33 -0.08 1.6 8.12 -0.09 1.4 5.43 -0.04 1.7 9.46 -0.02 1.5

Siemens DCA Vantage 395 5.16 -0.09 2.4 6.38 -0.03 2.4 8.23 0.02 2.4 5.43 -0.04 2.6 9.48 0.00 3.3

Siemens Dimension ExL 197 5.31 0.06 2.8 6.57 0.16 2.5 8.08 -0.13 2.2 5.54 0.07 2.8 9.28 -0.20 2.3

Siemens Dimension Vista 279 5.23 -0.02 2.9 6.49 0.08 2.7 8.03 -0.18 2.1 5.47 0.00 2.6 9.14 -0.34 2.3

Siemens Dimension Xpand 14 5.21 -0.04 2.7 6.57 0.16 2.1 8.06 -0.15 1.9

Tosoh G8 Automated HPLC 337 5.30 0.05 1.9 6.65 0.24 1.6 8.46 0.25 1.4 5.56 0.09 1.7 9.79 0.31 1.4

Tosoh G11 Automated HPLC 11 5.20 -0.05 2.6 6.49 0.08 2.1 8.27 0.06 1.9
Trinity Biotech Premier Hb9210
86 5.37 0.12 2.1 6.46 0.05 1.8 8.41 0.20 1.6 5.61 0.14 2.0 9.73 0.25 1.7
HPLC
Vitros 5,1 FS/4600/5600
194 5.30 0.05 3.0 6.54 0.13 3.4 8.25 0.04 2.8 5.52 0.05 3.3 9.46 -0.02 3.0
Chemistry Systems

Gray shading indicates bias > 0.3% HbA1c or CV > 3.5%     Note: these are arbitrary limits chosen to highlight methods with the highest bias and CV.

Figure 1: Bias and Variability from the NGSP Target

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Table 2: Overall Variability for 2010-2018 for all GH participants

All method
Mailing Sample# # of labs Target mean S.D. C.V.

01 2573 5.9 6.03 0.23 3.9

A-2010 02 2566 9.8 9.73 0.39 4.0
03 2581 7.4 7.43 0.31 4.2
04 2693 5.2 5.34 0.21 4.0
B-2010 05 2691 8.7 8.67 0.33 3.8
06 2685 6.3 6.37 0.23 3.5
01 2652 8.5 8.58 0.28 3.2
A-2011 02 2645 5.4 5.52 0.20 3.5
03 2649 6.4 6.51 0.21 3.2
04 2877 6.3 6.36 0.24 3.8
B-2011 05 2872 7.6 7.69 0.29 3.8
06 2871 9.2 9.28 0.34 3.7
01 3298 5.6 5.62 0.20 3.5
A 2012 02 3316 9.4 9.44 0.37 3.9
03 3301 7.2 7.28 0.29 3.9
04 3222 5.4 5.51 0.21 3.9
B2012 05 3208 8.3 8.31 0.31 3.7
06 3172 5.65 5.75 0.32 5.6
A 2013 01 2816 7.1 7.12 0.25 3.5
02 2829 9.3 9.39 0.31 3.3
03 2840 6.1 6.13 0.24 3.9
04 2912 8.1 8.04 0.31 3.8
B2013 05 2907 5.3 5.33 0.20 3.8
06 2908 6.4 6.17 0.24 3.9
01 3277 6.5 6.60 0.25 3.8
A2014 02 3267 7.0 7.09 0.27 3.8
03 3253 9.7 9.72 0.33 3.4
04 3278 6.58 6.64 0.23 3.5
B2014 05 3273 8.39 8.45 0.30 3.6
06 3266 5.65 5.67 0.21 3.6
01 3237 6.79 6.82 0.25 3.6
02 3246 10.28 10.19 0.36 3.5
A2015 03 3252 6.82 6.82 0.25 3.6
04 2365 8.63 8.63 0.30 3.4
05 2362 5.32 5.36 0.18 3.4
06 2379 5.84 5.87 0.2 3.5
07 2392 11.71 11.68 0.44 3.8
B2015 08 2402 9.53 9.5 0.33 3.5
09 2386 5.04 5.08 0.17 3.4
10 2403 7.38 7.35 0.26 3.5
11 3284 11.69 11.68 0.47 4.1
12 3285 5.93 5.95 0.19 3.3
C2015 13 3286 5.17 5.2 0.17 3.3
14 2410 8.14 8.12 0.24 2.9
15 2408 9.3 9.25 0.29 3.2

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 01 3358 5.32 5.33 0.16 3.1
02 3365 9.17 9.21 0.28 3.0
A2016 03 3357 5.31 5.33 0.16 3.1
04 2425 12.03 12.12 0.40 3.3
05 2419 5.94 5.96 0.16 2.8
06 2433 5.27 5.27 0.15 2.8
07 2427 10.59 10.55 0.33 3.1
B2016 08 2440 6.20 6.17 0.18 2.9
09 2428 12.23 12.21 0.44 3.6
10 2443 7.51 7.52 0.20 2.7
11 3377 9.11 9.08 0.24 2.6
12 3402 6.01 5.99 0.16 2.6
C2016 13 3372 11.71 11.69 0.39 3.4
14 2432 5.02 5.02 0.16 3.2
15 2442 7.58 7.58 0.19 2.5
01 3418 6.41 6.45 0.2 3.1
02 3393 9.53 9.56 0.28 2.9
A2017 03 3409 5.34 5.35 0.17 3.1
04 2461 8.51 8.58 0.23 2.7
05 2460 7.25 7.33 0.19 2.6
06 2446 7.42 7.49 0.22 3.0
07 2445 5.2 5.22 0.19 3.6
B2017 08 2450 8.31 8.33 0.21 2.5
09 2443 10.33 10.38 0.31 3.0
10 2457 5.87 5.91 0.19 3.2
11 3331 7.25 7.28 0.19 2.6
12 3339 6.81 6.85 0.2 3.0
C2017 13 3344 8.65 8.64 0.23 2.6
14 2431 9.5 9.54 0.26 2.8
15 2419 5.45 5.45 0.16 2.9
01 3371 7.15 7.16 0.21 3.0
02 3343 5.19 5.20 0.19 3.6
A2018 03 3369 8.42 8.39 0.24 2.9
04 2466 9.79 9.75 0.29 2.9
05 2473 6.12 6.13 0.18 3.0
06 2442 6.31 6.34 0.19 2.9
07 2443 9.11 9.09 0.25 2.8
B2018 08 2446 5.31 5.30 0.15 2.9
09 2448 8.35 8.40 0.21 2.5
10 2446 7.62 7.64 0.19 2.5
11 3311 9.37 9.31 0.27 3.0
12 3291 4.92 4.96 0.16 3.2
C2018 13 3300 6.04 6.09 0.18 3.0
14 2463 5.28 5.32 0.17 3.1
15 2469 8.08 8.11 0.24 3.0
01 3136 5.46 5.45 0.20 3.6
02 3089 5.66 5.71 0.25 4.4
A2019 03 3232 9.31 9.29 0.29 3.1
04 2470 5.28 5.24 0.17 3.3
05 2482 7.41 7.43 0.20 2.7

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 06 2462 6.41 6.44 0.18 2.8
07 2460 8.60 8.66 0.29 3.3
B2019 08 2461 5.42 5.41 0.16 2.9
09 2467 7.38 7.44 0.19 2.6
10 2457 9.75 9.77 0.31 3.2
11 3268 5.25 5.20 0.16 3.0
12 3283 6.41 6.44 0.19 3.0
C2019 13 3283 8.21 8.23 0.24 2.9
14 2463 5.47 5.45 0.15 2.8
15 2461 9.48 9.50 0.28 3.0

CVs below 3.5% are highlighted in pink

CVs below 3.0% are highlighted in blue
HbAS samples is indicated in yellow