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Evaluation of the ARKRAY HA-8190V instrument for HbA1c

  • Eline A.E. van der Hagen EMAIL logo , Sanne Leppink , Karin Bokkers , Carla Siebelder and Cas W. Weykamp
Published/Copyright: December 24, 2020
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 59 Issue 5

Abstract

Objectives

Hemoglobin A1c (HbA1c) is a valuable parameter in the monitoring of diabetic patients and increasingly in diagnosis of diabetes. Manufacturers continuously optimize instruments, currently the main focus is to achieve faster turnaround times. It is important that performance specifications remain of high enough standard, which is evaluated in this study for the new ARKRAY HA-8190V instrument.

Methods

The Clinical and Laboratory Standards Institute (CLSI) protocols EP-5, EP-9 and EP-10 were applied to investigate imprecision, bias and linearity. In addition potential interferences, performance in External Quality Assessment (EQA) and performance against the HA-8180V instrument in 220 clinical samples was evaluated.

Results

The HA-8190V demonstrates a CV of ≤0.8% in IFCC SI units (≤0.6% National Glycohemoglobin Standardization Program [NGSP]) at 34 and 102 mmol/mol levels (5.3 and 11.5% NGSP) and a bias of −0.1 mmol/mol (−0.01% NGSP) at a concentration of 50 mmol/mol (6.7% NGSP), but with a significant slope as compared to target values. This results in a bias of −1.0 and 0.9 mmol/mol (−2.0 and 0.9% NGSP) at the 30 and 70 mmol/mol (4.9 and 8.6% NGSP) concentration level. Simulation of participation in the IFCC certification programme results in a Silver score (bias −0.1 mmol/mol, CV 1.1%). Interference in the presence of the most important Hb variants (AS, AC, AE, AD) and elevated HbA2 and HbF concentrations is less than 3 mmol/mol (0.3% NGSP) at a concentration of 50 mmol/mol (6.7% NGSP).

Conclusions

Analytical performance of the HA-8190V is very good, especially with respect to precision and HbA1c quantification in the presence of the most common Hb variants.

Keywords: ARKRAY HA-8190V; diabetes; HbA1c ; Hb variants; performance specifications

Introduction

Hemoglobin A1c (HbA1c) is the key parameter for monitoring of glycemic control in diabetic patients [1], [2]. Due to increased standardization, HbA1c is used more and more as diagnostic criterion as well [3]. In 2011, the World Health Organization concluded that HbA1c could be used as diagnostic test [4], but already in 2010, it was incorporated as diagnostic criterium in the American Diabetes Association Standards of Diabetes Care [5]. Performance of instruments in terms of precision and trueness are key to reliable results. Now that this seems well established in most methods, manufacturers are focusing on similar specifications for Point-Of-Care Devises [6], [7], and for the laboratory instruments on decreasing time of analysis and smaller sample volumes. HPLC ion-exchange chromatography is one of the major techniques used for HbA1c analysis. In succession of the widely used HA-8180V instrument, ARKRAY has developed the ARKRAY HA-8190V with regular (variant mode) analysis times of 58 s (vs. 90 s of the HA-8180V) and in fast mode 24 s (vs. 48 s HA-8180V). Sample volume has decreased from ∼14 to 8 µL. Other new features vs. the HA-8180V are as follows: tube spinning has been added to enable easier barcode reading, the instrument can be operated through a touch screen and automatic switching between the fast and variant mode is made possible. To evaluate whether these improvements did not affect quality of the HbA1c result, the HA-8190V was evaluated in this study.

Materials and methods

Instruments

HbA1c analyses were performed on the ARKRAY HA-8190V (ion-exchange HPLC) as installed by ARKRAY, calibrated and controlled with ARKRAY supplied calibrators and controls. Samples were measured in the variant mode. Results were compared to HbA1c analysis on the ARKRAY HA-8180V (ion-exchange HPLC) and/or Trinity Biotech Premier Hb9210 (affinity chromatography HPLC), all International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) calibrated. Quantification of Hb variants and HbA2/HbF is performed using the Sebia CAPILLARYS 2 FLEX PIERCING. Due to the nature of the boronate affinity technique, quantifying all glycated Hb vs. all non-glycated Hb as opposed to ion-exchange quantifying HbA1c, interference by additional peaks of the variant (HbX0 and HbX1c) is excluded and therefore this technique is more suited for reliable measurement of Hb variants. The HA-8190V instrument was calibrated once at the start of the study (calibration coefficients a 1.0032; b −2.0), with the exception of the EP10 study, which was performed later after an additional calibration (a 0.9952; b −2.4).

Reagents and samples

For calibration, the 2-set ARKRAY calibrator 90 was used (lot CA99C09). For internal Quality Control, ARKRAY controls were used (extendSURE™, level 1/2, lot 7094), these were also used for the performed Clinical and Laboratory Standards Institute (CLSI) EP-5 and EP-10 protocols [8], [9]. For CLSI EP-9, 40 IFCC targeted (using eight IFCC certified secondary reference measurement procedures, five of them also National Glycohemoglobin Standardization Program, NGSP, certified) frozen whole blood samples were used [10]. For comparison studies of the HA-8190V vs. the HA-8180V, 120 patient samples were collected freshly from left-over material at the Queen Beatrix Hospital. For studies on Hb variants, samples were collected from our Biobank of frozen whole blood samples. Samples with elevated labile HbA1c as measured using HA-8180V, high bilirubin (as measured using Roche cobas c501) and hematocrit range (as estimated by Hb using Sysmex XT-4000i) were prepared freshly, samples with elevated carbamylated Hb were collected from our Biobank of frozen whole blood samples as prepared according to protocol [11]. For mimicking of participation in External Quality Assessment (EQA) programmes, the IFCC certification programme for manufacturers 2019 (24 frozen whole blood samples) and European Reference Laboratory for Glycohemoglobin (ERL) EQA programme 2019 (12 lyophilized hemolysate samples in duplicate) were used. All specimens were acquired in agreement with the principles of the Declaration of Helsinki.

Data analysis

CLSI EP-5, EP-9 and EP-10 results were evaluated using EP-evaluator (Data Innovations, South Burlington, VT, USA, version 12.0.0.11). Deviation from target (bias) is calculated from slope and intercept from regression analysis. Calculations for mimicking of EQA programmes (IFCC certification and ERL EQA programme) are performed according to their standard procedure, in short: Linear regression analysis, deviation from target as described above, CV from scatter around the regression line and from Δ between duplicate measurements respectively, Total Error = |B| + 2I at 50 and 60 mmol/mol respectively, with |B| being absolute bias and I being imprecision. Linear regression analysis for Hb variants and elevated HbA2/HbF was performed in Prism 6 (Graphpad Software, San Diego, CA, USA).

Results

Precision and trueness

Precision was evaluated using the CLSI EP-5 protocol: On 20 working days, a low (34 mmol/mol; 5.3% NGSP) and high (102 mmol/mol; 11.5% NGSP) control sample were assayed in duplicate twice a day in an analytical run with at least 10 other samples. The four EP-5 parameters for precision are listed in Table 1, total CV is ≤0.8% (≤0.6% NGSP) for both control levels. Trueness was evaluated using the CLSI EP-9 protocol; to assess traceability to the IFCC reference measurement procedure and NGSP reference method, IFCC targeted samples were used. EP-9 parameters are presented in Table 2 and demonstrate a statistically significant slope and intercept. When this is expressed as bias at different HbA1c concentration levels, it can be observed that bias is small (−0.1 mmol/mol; −0.01% NGSP) at the clinically relevant 50 mmol/mol (6.7% NGSP) concentration level but ≥0.9 mmol/mol (0.08% NGSP) at lower/higher concentrations. Based on the IFCC certification criteria (at the 50 mmol/mol level) the overall result of EP-5 and EP-9 would be classified as very good (Total Error allowable, TEa <4.4%). The results are summarized in Figure 1 (EP).

Table 1:

Reproducibility ARKRAY HA-8190V according to the CLSI EP-5 protocol using the ARKRAY controls low and high.

EP-5 parameters Low HbA1c level 34 mmol/mol (5.3% NGSP) High HbA1c level 102 mmol/mol (11.5% NGSP)
Within-run CV 0.5% (0.4%) 0.4% (0.3%)
Between-run CV 0.4% (0.3%) 0.4% (0.3%)
Between day CV 0.4% (0.2%) 0.4% (0.4%)
Total CV 0.8% (0.5%) 0.7% (0.6%)
Table 2:

Trueness ARKRAY HA-8190V according to the CLSI EP-9 protocol using a 40 sample set with values assigned using eight IFCC calibrated and certified secondary reference measurement procedures.

Result mmol/mol

(% NGSP)		 95% Confidence interval
EP-9 parameters
Slope 1.048 (1.048)a 1.041 to 1.055 (1.041–1.056)
Intercept −2.47 (−0.332)a −2.91 to −2.03 (−0.388 to −0.275)
Difference between measured and assigned values
Low −1.0 (−0.10)a −1.7 to −0.4 (−0.19 to 0.00)
Medium −0.1 (−0.01) −0.9 to 0.7 (−0.11 to 0.10)
High +0.9 (+0.08) 0.0 to 1.8 (−0.04 to 0.21)

  1. Parameters of Deming regression analysis are shown.

    aStatistically significant, 1.000 (slope) or 0 (intercept/bias) are not within confidence interval limits.

Figure 1: Summary of results. Absolute bias (mmol/mol; % National Glycohemoglobin Standardization Program [NGSP]) and imprecision (CV %) and thereby TEa are presented for EP-5/EP-9 results (EP), the two mimicked External Quality Assessment (EQA) programmes: IFCC Certification programme 2019 for manufacturers (IF, 24 frozen whole blood samples) and ERL EQA programme (ER, 12 lyophilized hemolysates in duplicate).
Figure 1:

Summary of results.

Absolute bias (mmol/mol; % National Glycohemoglobin Standardization Program [NGSP]) and imprecision (CV %) and thereby TEa are presented for EP-5/EP-9 results (EP), the two mimicked External Quality Assessment (EQA) programmes: IFCC Certification programme 2019 for manufacturers (IF, 24 frozen whole blood samples) and ERL EQA programme (ER, 12 lyophilized hemolysates in duplicate).

Linearity, carry-over and drift

The CLSI EP-10 protocol was used to evaluate linearity, carry-over and drift: three samples (low, medium, high; medium is 1:1 mix low and high corrected for Hb concentration, hence 100:102.4) were analyzed. The results are summarized in Table 3. The critical t-value of 4.6 is not exceeded, indicating no statistically significant nonlinearity, carry-over and/or drift.

Table 3:

Carry-over, linearity, drift ARKRAY HA-8190V according to the CLSI EP-10 protocol using the ARKRAY control low and high.

EP-10 parameters Result mmol/mol (% NGSP) t-Value
Intercept −0.25 (−0.02) −3.8 (−3.7)
Slope 1.002 (1.002) 0.8 (0.7)
% Carry-over −0.04 (−0.01) −0.2 (0.0)
Nonlinearity 0.00038 (0.00418) 3.0 (3.0)
Drift 0.03 (0.00) 1.3 (1.3)

  1. A t-value >4.6 means statistically significance, p<0.01.

External quality assessment

To predict performance of the AKRAY HA-8190V in EQA schemes, participation in two schemes was mimicked: the 2019 IFCC certification programme for manufacturers (24 frozen whole blood samples) and the 2019 ERL EQA programme (12 lyophilized hemolysates in duplicate). Results are presented in Table 4 and summarized in Figure 1 (IF and ER respectively). Overall grade in the IFCC certification programme is “silver” (TEa <4.4%) and for the ERL EQA programme “excellent” (bias <2 mmol/mol; CV <2%; R>0.9970). TEa is also <4.4% for the latter and would also classify as silver/very good according to the IFCC certification criteria.

Table 4:

Performance in EQAS: the IFCC certification programme 2019 (24 frozen whole blood samples) and the ERL EQA programme 2019 (12 lyophilized hemolysates in duplicate). For the IFCC programme low, medium, high is 30, 50, 70 mmol/mol (4.9, 6.7, 8.6% NGSP) respectively; for the ERL programme 30, 60, 90 mmol/mol (4.9, 7.6, 10.4% NGSP).

EQA parameters IFCC certification for manufacturers ERL EQA programme
Slope 1.030 (1.030) 1.022 (1.022)
Intercept −1.63 (−0.214) −0.03 (−0.050)
Deviation from target
Low −0.7 (−0.07) +0.6 (+0.06)
Medium −0.1 (−0.01) +1.3 (+0.12)
High +0.5 (+0.04) +1.9 (+0.18)
CV, % 1.1 (0.81) 0.2 (0.16)
Total Errora 1.2 (0.11) 1.5 (0.13)
R 0.9995 0.9999
Grade Silver Excellent

  1. aTotal Error in mmol/mol for medium concentration of HbA1c.

Comparison to the HA-8180V

Performance of the HA-8190V vs. its predecessor HA-8180V (IFCC calibrated) in a clinical setting was evaluated by measuring 40 non-diabetic persons and 180 diabetic patients, resulting in HbA1c concentrations ranging from 30 mmol/mol (4.9% NGSP) to 114 mmol/mol (12.6% NGSP). Linear regression analysis reveals a correlation coefficient (R2) of >0.998. While Deming regression analysis (Figure 2A) demonstrates a statistically significant slope (1.084, 95% CI 1.078–1.090) and intercept (−3.5 mmol/mol, 95% CI −3.9 to −3.2; −0.50% NGSP, 95% CI −0.55 to −0.46)), resulting in a bias of +0.7 mmol/mol (0.06 %NGSP) at the 50 mmol/mol (6.7% NGSP) level. The Bland–Altman plot (Figure 2B) demonstrates an average bias of 1.4 mmol/mol (95% limits of agreement −1.8 to 4.5), with a negative bias at low and a positive bias at high HbA1c concentrations when compared to the HA-8180V.

Figure 2: Comparison between ARKRAY HA-8190V and HA-8180V. (A) Deming regression plot for HbA1c (mmol/mol). Best-fit slope 1.084, 95% CI 1.078–1.090; intercept −3.536, 95% CI −3.900 to −3.172. (B) Bland–Altman difference plot (HA-8190V–HA-8180V), bias 1.4 mmol/mol, 95% limits of agreement −1.8 to 4.5 mmol/mol.
Figure 2:

Comparison between ARKRAY HA-8190V and HA-8180V.

(A) Deming regression plot for HbA1c (mmol/mol). Best-fit slope 1.084, 95% CI 1.078–1.090; intercept −3.536, 95% CI −3.900 to −3.172. (B) Bland–Altman difference plot (HA-8190V–HA-8180V), bias 1.4 mmol/mol, 95% limits of agreement −1.8 to 4.5 mmol/mol.

Interferences

The potential interference of high labile-HbA1c (Schiff base, 20 mg/mL glucose incubation resulted in 4.3% labile HbA1c), high bilirubin concentrations and low/high hematocrit was evaluated and found to be <1 mmol/mol (0.1% NGSP) (Table 5, Supplementary Figure 1A, B). For samples with high carbamylated Hb, a significant interference >5 mmol/mol was observed in the presence of 3.4% carbamylated Hb (Supplementary Figure 1C, D). Furthermore, potential interference of Hb variants was investigated. For HbAS, HbAC, HbAE and HbAD, 20 different patient samples were measured and compared to results derived from affinity chromatography (Trinity Biotech Premier Hb9210). The results are summarized in Table 6 and Supplementary Figure 2. Correlation (R2) is >0.980 for all four variants, and no significant bias was observed (within 10% limits of HbA regression line). Mean bias is less than 3 mmol/mol (0.3% NGSP). Also effects of elevated HbF (20 samples, 2.7–36% HbF) and HbA2 (15 samples, 4.4–9.2 % HbA2; five samples are also part of the elevated HbF sample set and could therefore not be compared to Trinity Premier Hb9120 target values) were evaluated against the HA-8180V and Trinity Premier Hb9120 respectively (Supplementary Figure 3). No concentration dependent effect on HbA1c concentration vs. reference value (bias in mmol/mol; % NGSP) was observed (slope 0 within 95% CI). For the tested homozygous variants (HbSS, HbSC, HbEE, HbDD, n=1 for all) an adequate warning was given that no HbA1c could be detected (Supplementary Figure 4). In addition some uncommon heterozygous variants were tested (HbAJ, HbAO-Arab, HbAQ-Iran, n=1 for all), abnormal patterns were observed and HbA1c was not adequately quantified. For HbAO-Arab and HbAQ-Iran, no warnings were given.

Table 5:

Potential interferences influence on HbA1c result.

Potential interferent Effect on HbA1c, mmol/mol (% NGSP)
Labile HbA1c (4.3%) <1 (<0.1)
Carbamylated Hb (3.4%) >5 (>0.5)
Hematocrit (Hb 4–14 mmol/L) <1 (<0.1)
Bilirubin (258 μmol/L) <1 (<0.1)
Table 6:

Hb variants influence on HbA1c result.

Hb variant Abnormal chromatogram Variant peak identified Variant peak quantitated Linear correlation reference value Effect on HbA1c mmol/mola (% NGSP)
HbAS Yes Yes Yes R2 > 0.998 −1.4 (−0.13)
HbAC Yes Yes Yes R2 > 0.998 −2.6 (−0.24)
HbAE Yes Yes No R2 > 0.988 1.2 (0.10)
HbAD Yes Yes No R2 > 0.983 1.8 (0.16)
HbF Yes Yes Yes R2 > 0.996 0.8 (0.07)
HbA2 No No No R2 > 0.999 0.9 (0.09)
Other Yesb No No n.a. >5 (>0.5)

  1. aAt 50 mmol/mol concentration level from Deming regression analysis vs. assigned value with Trinity Premier Hb9210.

    bTwo of seven no warning is given (HbO-Arab, HbQ-Iran).

    cFor three of seven, four are not quantified due to absence of HbA0 and hence HbA1c (homozygous variants).

Discussion

In this study, we evaluated the performance of the new ARKAY HA-8190V for quantitative measurements of HbA1c concentrations. Key results are: Precision is excellent; Trueness is excellent at the 50 mmol/mol level but could be improved for the lower and higher concentration levels as a significant slope is present. These results were confirmed by mimicking participation in the 2019 IFCC certification programme (frozen whole blood) and 2019 ERL EQA programme (lyophilized hemolysates). In the programme with lyophilized samples, bias was higher and imprecision (CV) lower, however, resulting in a similar Total Error. In accordance to an earlier study by Moriguchi et al., influence of interferences is overall very low [12]. However, we do see some points of attention. Finally, correlation with the former HA-8180V (calibrated using IFCC calibrators) in patient samples is excellent, but a significant bias is present. All components in this study, EP-9, the two EQA programmes and comparison to the HA-8180V, point toward a significant slope that results in acceptable biases at the clinically relevant 50 mmol/mol (6.7% NGSP) level, but significant positive biases at higher concentration levels from 0.5 in the IFCC programme to 2.3 mmol/mol (0.04 and 0.22% NGSP) in comparison with the HA-8180V. Negative biases at 30 mmol/mol level range from −1.0 for the EP-9 protocol and HA-8180V results to −0.7 mmol/mol (−0.09 and −0.07% NGSP) in the IFCC programme. Although, the slope is similar, ERL programme shows a different trend regarding bias, with a positive bias at all three concentrations, probably due to an overall positive bias on top of the observed slope due to the use of lyophilized samples.

In the EQA mimicking programme, slightly higher biases were observed for lyophilized samples as compared to whole blood samples. A generally known artifact [13], that has also been regularly observed in the yearly EurA1c trial for other instruments (while for some instruments use of lyophilized samples is not possible at all) including the predecessor HA-8180V [14]. When bias of HA-8190V vs. HA-8180V in fresh whole blood and lyophilized samples is examined (n=5) no clear differences where observed (data not shown), indicating that the HA-8190V probably behaves similar to the known HA-8180V with respect to lyophilized samples.

Precision of the HA-8190V of 0.8% is gold/excellent when judged according to the IFCC quality targets (<1.1%) and well within the 2% of the international desirable performance standards [15]. Although within-run CV seems to have deteriorated a bit as compared to the HA-8180V overall CV appears to have been slightly improved [16]. Trueness (−0.1 mmol/mol; −0.01% NGSP) at the clinically relevant 50 mmol/mol concentration range is gold/excellent (<1.1%) according to the IFCC quality targets as well. However due to a significant slope, accuracy at the lower and higher concentration levels could be improved. This bias was also observed in the clinical study where performance of the HA-8190V was compared to its predecessor the HA-8180V (the latter being IFCC calibrated, not with ARKRAY’s regular calibrators). Hopefully this might be improved with the release of new calibrator lots and should be carefully monitored.

Influence of commonly present Hb variants is absent and therefore performance in this regard is excellent. Results are comparable to that of the HA-8180V with regard to correlation coefficient and mean bias [17]. Ofcourse caution has always to be taken with respect to the analysis of HbA1c in the presence of Hb variants, as for example erythrocyte lifespan might be affected. Whereas for the HA-8180V no interference of carbamylated Hb was reported [16]. In this study, measurements with the HA-8180V were performed as well and demonstrated only a minor positive bias (<2 mmol/mol; 2.4% NGSP), while for the HA-8190V a significant bias was observed in the presence of 3.4% carbamylated Hb. Carbamylated Hb is formed as a result of the reaction of Hb with urea-derived isocyanate in patients with high levels of urea [18]. Studies demonstrated that carbamylated Hb increases with about 0.063% for every 1 mmol/L urea [11], thus corresponding to 55 mmol/L urea in this case. Although quite high, these levels might be clinically relevant in patients with for example end stage renal disease. Earlier studies demonstrated an average +1.6% for different HPLC ion-exchange chromatography instruments in a sample with a 27.9 mmol/L urea level [19], where more recent studies suggest that due to improved separation of the HbA1c fraction interference of carbamylation is not significant anymore [20]. However, other studies for the Bio-Rad Variant II instrument demonstrate biases up to −13.7% in patient samples (urea 27.8 mmol/L), while for ion-exchange usually positive biases due to carbamylation interferences where observed [21], pointing to the importance of including potential interference in evaluation studies. It must be noted that the samples in this study were artificially prepared and commutability is not proven, hence further studies in clinical practice are recommended also to assess as to what the influence of intermediate urea levels would be. In contrast to the commonly present Hb variants for which correlation of the HA-8190V with affinity chromatography is excellent, for uncommon variants alertness is required, as the chromatogram is clearly different from normal, not always is warning given, whereas HbA1c results deviate significantly. Overall, the ARKRAY HA-8190V is an excellent successor of the HA-8180V, some points of attention are improvement of calibration and alertness regarding samples with high urea or uncommon Hb variants.

Corresponding author: Eline A.E. van der Hagen, European Reference Laboratory for Glycohemoglobin, Queen Beatrix Hospital, Winterswijk, The Netherlands; and Department of Clinical Chemistry, Queen Beatrix Hospital, Beatrixpark 1, 7101 BN, Winterswijk, The Netherlands, Phone: +31 543544774, E-mail:

Funding source: ARKRAY Inc

  1. Research funding: ARKRAY Inc, financially supported the study.

  2. Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  3. Competing interests: Authors state no conflict of interest.

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Supplementary Material

The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2020-1300).

Received: 2020-08-25
Accepted: 2020-12-11
Published Online: 2020-12-24
Published in Print: 2021-04-27

© 2020 Eline A.E. van der Hagen et al., published by De Gruyter, Berlin/Boston

This work is licensed under the Creative Commons Attribution 4.0 International License.

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Home pregnancy tests: quality first
  4. Review
  5. Non-invasive determination of uric acid in human saliva in the diagnosis of serious disorders
  6. Opinion Papers
  7. Basophil counting in hematology analyzers: time to discontinue?
  8. The role of laboratory hematology between technology and professionalism: the paradigm of basophil counting
  9. Recommendations for validation testing of home pregnancy tests (HPTs) in Europe
  10. General Clinical Chemistry and Laboratory Medicine
  11. The use of preanalytical quality indicators: a Turkish preliminary survey study
  12. The Italian External Quality Assessment (EQA) program on urinary sediment by microscopy examination: a 20 years journey
  13. Non-HDL-C/TG ratio indicates significant underestimation of calculated low-density lipoprotein cholesterol (LDL-C) better than TG level: a study on the reliability of mathematical formulas used for LDL-C estimation
  14. Evaluation of the protein gap for detection of abnormal serum gammaglobulin level: an imperfect predictor
  15. Impact of routine S100B protein assay on CT scan use in children with mild traumatic brain injury
  16. Using machine learning to develop an autoverification system in a clinical biochemistry laboratory
  17. Effect of collection matrix, platelet depletion, and storage conditions on plasma extracellular vesicles and extracellular vesicle-associated miRNAs measurements
  18. Pneumatic tube transportation of urine samples
  19. Evaluation of the first immunosuppressive drug assay available on a fully automated LC-MS/MS-based clinical analyzer suggests a new era in laboratory medicine
  20. A validated LC-MS/MS method for the simultaneous quantification of the novel combination antibiotic, ceftolozane–tazobactam, in plasma (total and unbound), CSF, urine and renal replacement therapy effluent: application to pilot pharmacokinetic studies
  21. Immunosuppressant quantification in intravenous microdialysate – towards novel quasi-continuous therapeutic drug monitoring in transplanted patients
  22. Reference Values and Biological Variations
  23. Reference intervals for venous blood gas measurement in adults
  24. Cardiovascular Diseases
  25. Detection and functional characterization of a novel MEF2A variation responsible for familial dilated cardiomyopathy
  26. Diabetes
  27. Evaluation of the ARKRAY HA-8190V instrument for HbA1c
  28. Infectious Diseases
  29. An original multiplex method to assess five different SARS-CoV-2 antibodies
  30. Evaluation of dried blood spots as alternative sampling material for serological detection of anti-SARS-CoV-2 antibodies using established ELISAs
  31. Variability of cycle threshold values in an external quality assessment scheme for detection of the SARS-CoV-2 virus genome by RT-PCR
  32. The vasoactive peptide MR-pro-adrenomedullin in COVID-19 patients: an observational study
  33. Corrigenda
  34. Corrigendum to: Understanding and managing interferences in clinical laboratory assays: the role of laboratory professionals
  35. Corrigendum to: Age appropriate reference intervals for eight kidney function and injury markers in infants, children and adolescents
  36. Letters to the Editor
  37. A panhaemocytometric approach to COVID-19: a retrospective study on the importance of monocyte and neutrophil population data on Sysmex XN-series analysers
  38. Letter in reply to the letter to the editor of Harte JV and Mykytiv V with the title “A panhaemocytometric approach to COVID-19: a retrospective study on the importance of monocyte and neutrophil population data”
  39. SARS-CoV-2 serologic tests: do not forget the good laboratory practice
  40. Long-term kinetics of anti-SARS-CoV-2 antibodies in a cohort of 197 hospitalized and non-hospitalized COVID-19 patients
  41. Self-sampling at home using volumetric absorptive microsampling: coupling analytical evaluation to volunteers’ perception in the context of a large scale study
  42. Vortex mixing to alleviate pseudothrombocytopenia in a blood specimen with platelet satellitism and platelet clumps
  43. Comparative evaluation of the fully automated HemosIL® AcuStar ADAMTS13 activity assay vs. ELISA: possible interference by autoantibodies different from anti ADAMTS-13
  44. Significant interference on specific point-of-care glucose measurements due to high dose of intravenous vitamin C therapy in critically ill patients
  45. As time goes by, on that you can rely … preservation of urine samples for morphological analysis of erythrocytes and casts
  46. Stability of control materials for α-thalassemia immunochromatographic strip test
  47. Reformulated Architect® cyclosporine CMIA assay: improved imprecision, worse comparability between methods
  48. Urine-to-plasma contamination mimicking acute kidney injury: small drops with major consequences
  49. Automated Mindray CL-1200i chemiluminescent assays of renin and aldosterone for the diagnosis of primary aldosteronism
  50. Use of common reference intervals does not necessarily allow inter-method numerical result trending
  51. Reply to Dr Hawkins regarding comparability of results for monitoring
https://doi.org/10.1515/cclm-2020-1300
Keywords for this article
ARKRAY HA-8190V; diabetes; HbA1c; Hb variants; performance specifications
Creative Commons
BY 4.0

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Home pregnancy tests: quality first
  4. Review
  5. Non-invasive determination of uric acid in human saliva in the diagnosis of serious disorders
  6. Opinion Papers
  7. Basophil counting in hematology analyzers: time to discontinue?
  8. The role of laboratory hematology between technology and professionalism: the paradigm of basophil counting
  9. Recommendations for validation testing of home pregnancy tests (HPTs) in Europe
  10. General Clinical Chemistry and Laboratory Medicine
  11. The use of preanalytical quality indicators: a Turkish preliminary survey study
  12. The Italian External Quality Assessment (EQA) program on urinary sediment by microscopy examination: a 20 years journey
  13. Non-HDL-C/TG ratio indicates significant underestimation of calculated low-density lipoprotein cholesterol (LDL-C) better than TG level: a study on the reliability of mathematical formulas used for LDL-C estimation
  14. Evaluation of the protein gap for detection of abnormal serum gammaglobulin level: an imperfect predictor
  15. Impact of routine S100B protein assay on CT scan use in children with mild traumatic brain injury
  16. Using machine learning to develop an autoverification system in a clinical biochemistry laboratory
  17. Effect of collection matrix, platelet depletion, and storage conditions on plasma extracellular vesicles and extracellular vesicle-associated miRNAs measurements
  18. Pneumatic tube transportation of urine samples
  19. Evaluation of the first immunosuppressive drug assay available on a fully automated LC-MS/MS-based clinical analyzer suggests a new era in laboratory medicine
  20. A validated LC-MS/MS method for the simultaneous quantification of the novel combination antibiotic, ceftolozane–tazobactam, in plasma (total and unbound), CSF, urine and renal replacement therapy effluent: application to pilot pharmacokinetic studies
  21. Immunosuppressant quantification in intravenous microdialysate – towards novel quasi-continuous therapeutic drug monitoring in transplanted patients
  22. Reference Values and Biological Variations
  23. Reference intervals for venous blood gas measurement in adults
  24. Cardiovascular Diseases
  25. Detection and functional characterization of a novel MEF2A variation responsible for familial dilated cardiomyopathy
  26. Diabetes
  27. Evaluation of the ARKRAY HA-8190V instrument for HbA1c
  28. Infectious Diseases
  29. An original multiplex method to assess five different SARS-CoV-2 antibodies
  30. Evaluation of dried blood spots as alternative sampling material for serological detection of anti-SARS-CoV-2 antibodies using established ELISAs
  31. Variability of cycle threshold values in an external quality assessment scheme for detection of the SARS-CoV-2 virus genome by RT-PCR
  32. The vasoactive peptide MR-pro-adrenomedullin in COVID-19 patients: an observational study
  33. Corrigenda
  34. Corrigendum to: Understanding and managing interferences in clinical laboratory assays: the role of laboratory professionals
  35. Corrigendum to: Age appropriate reference intervals for eight kidney function and injury markers in infants, children and adolescents
  36. Letters to the Editor
  37. A panhaemocytometric approach to COVID-19: a retrospective study on the importance of monocyte and neutrophil population data on Sysmex XN-series analysers
  38. Letter in reply to the letter to the editor of Harte JV and Mykytiv V with the title “A panhaemocytometric approach to COVID-19: a retrospective study on the importance of monocyte and neutrophil population data”
  39. SARS-CoV-2 serologic tests: do not forget the good laboratory practice
  40. Long-term kinetics of anti-SARS-CoV-2 antibodies in a cohort of 197 hospitalized and non-hospitalized COVID-19 patients
  41. Self-sampling at home using volumetric absorptive microsampling: coupling analytical evaluation to volunteers’ perception in the context of a large scale study
  42. Vortex mixing to alleviate pseudothrombocytopenia in a blood specimen with platelet satellitism and platelet clumps
  43. Comparative evaluation of the fully automated HemosIL® AcuStar ADAMTS13 activity assay vs. ELISA: possible interference by autoantibodies different from anti ADAMTS-13
  44. Significant interference on specific point-of-care glucose measurements due to high dose of intravenous vitamin C therapy in critically ill patients
  45. As time goes by, on that you can rely … preservation of urine samples for morphological analysis of erythrocytes and casts
  46. Stability of control materials for α-thalassemia immunochromatographic strip test
  47. Reformulated Architect® cyclosporine CMIA assay: improved imprecision, worse comparability between methods
  48. Urine-to-plasma contamination mimicking acute kidney injury: small drops with major consequences
  49. Automated Mindray CL-1200i chemiluminescent assays of renin and aldosterone for the diagnosis of primary aldosteronism
  50. Use of common reference intervals does not necessarily allow inter-method numerical result trending
  51. Reply to Dr Hawkins regarding comparability of results for monitoring
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