HemoCue Hb-801 Provides More Accurate Hemoglobin Assessment in Blood Donors Than OrSense NBM-200.

Hemoglobin levels are commonly assessed to prevent causing or worsening of anemia in prospective blood donors. We compared head-to-head the accuracy of different technologies for measuring hemoglobin suitable for use in mobile donation units. We included 144 persons donating platelets at the Central Institute for Blood Transfusion and Immunology in Innsbruck, Austria. Hemoglobin levels were measured in venous blood using the portable hemoglobinometer HemoCue Hb-801 and noninvasively using OrSense NBM-200, and compared to values obtained with the Sysmex XN-430, an automated hematology analyzer employing the sodium lauryl sulphate method, which is broadly used as reference method in everyday clinical practice. Mean age of participants was 34.2 years (SD 13.0); 34.0% were female. Hemoglobin values measured with HemoCue were more strongly correlated with the Sysmex XN-430 (r = 0.90 [95% CI: 0.87-0.93]) than measured with OrSense (r = 0.49 [0.35-0.60]). On average, HemoCue overestimated hemoglobin by 0.40 g/dL (0.31-0.48) and OrSense by 0.75 g/dL (95% CI: 0.54-0.96). When using OrSense, we found evidence for higher overestimation at higher hemoglobin levels (proportional bias) specifically in females but not in males (Pdifference = .003). Sensitivity and specificity for classifying donors according to the hemoglobin donation thresholds were 99.2% (95% CI: 95.3%-100.0%) and 43.8% (23.1%-66.8%) for HemoCue vs 95.3% (89.9%-98.0%) and 12.5% (2.2%-37.3%) for OrSense. Areas under the receiver operating characteristic curves were higher using HemoCue vs OrSense both in females (0.933 vs 0.547; P = .044) and males (0.948 vs 0.628; P < .001). HemoCue Hb-801 measures hemoglobin more accurately than OrSense NBM-200 in the setting of mobile blood donation units. Our findings are particularly relevant for females, having in mind that anemia is more prevalent in females than in males.

Non-invasive hemoglobin measurement devices require refinement to match diagnostic performance with their high level of usability and acceptability.

Anemia remains an important global health problem. Inexpensive, accurate, and noninvasive solutions are needed to monitor and evaluate anemia in resource-limited settings. We evaluated the performance of multiple point-of-care hemoglobin devices, including a novel noninvasive smartphone application tested on Apple® and Android® cell phones, Masimo Pronto®, and HemoCue® Hb-301 and Hb-801, against a gold-standard hematology analyzer (reference hemoglobin) using venous blood. We examined correlations between hemoglobin devices and reference hemoglobin, device accuracy (average bias, Bland-Altman plots, clinical performance) and classification bias (sensitivity, specificity) among 299 refugees (10mo-65y) in Atlanta, GA. Semi-structured interviews (n = 19) with participants and staff assessed usability and acceptability. Mean reference hemoglobin was 13.7 g/dL (SD:1.8) with 12.5% anemia. Noninvasive hemoglobin devices were not well correlated with reference hemoglobin (Apple® R2 = 0.08, Android® R2 = 0.11, Masimo Pronto® R2 = 0.29), but stronger correlations were reported with HemoCue® Hb-301 (R2 = 0.87) and Hb-801 (R2 = 0.88). Bias (SD) varied across each device: Apple®: -1.6 g/dL (2.0), Android®: -0.7 g/dL (2.0), Masimo Pronto®: -0.4 g/dL (1.6), HemoCue® Hb-301: +0.4 g/dL (0.7) and HemoCue® Hb-801: +0.2 g/dL (0.6). Clinically acceptable performance (within ± 1 g/dL of reference hemoglobin) was higher for the invasive devices (HemoCue® Hb-301: 90.3%; HemoCue® Hb-801: 93.4%) compared to noninvasive devices (Apple®: 31.5%; Android®: 34.6%; Masimo Pronto®: 49.5%). Sensitivity and specificity were 63.9% and 48.2% for Apple®, 36.1% and 67.6% for Android®, 45.7% and 85.3% for Masimo Pronto®, 54.3% and 97.6% for HemoCue® Hb-301, and 66.7% and 97.6% for HemoCue® Hb-801. Noninvasive devices were considered easy to use and were the preferred method by participants. Among the only studies to compare multiple point-of-care approaches to hemoglobin testing, the diagnostic ability of HemoCue® was comparable to reference hemoglobin, while noninvasive devices had high user acceptability but considerable biases. Improvements in noninvasive device performance and further testing in anemic populations are recommended before broader use.

Comparison of four methods to measure haemoglobin concentrations in whole blood donors (COMPARE): A diagnostic accuracy study.

OBJECTIVE: To compare four haemoglobin measurement methods in whole blood donors. BACKGROUND: To safeguard donors, blood services measure haemoglobin concentration in advance of each donation. NHS Blood and Transplant's (NHSBT) customary method have been capillary gravimetry (copper sulphate), followed by venous spectrophotometry (HemoCue) for donors failing gravimetry. However, NHSBT's customary method results in 10% of donors being inappropriately bled (ie, with haemoglobin values below the regulatory threshold). METHODS: We compared the following four methods in 21 840 blood donors (aged ≥18 years) recruited from 10 NHSBT centres in England, with the Sysmex XN-2000 haematology analyser, the reference standard: (1) NHSBT's customary method; (2) "post donation" approach, that is, estimating current haemoglobin concentration from that measured by a haematology analyser at a donor's most recent prior donation; (3) "portable haemoglobinometry" (using capillary HemoCue); (4) non-invasive spectrometry (using MBR Haemospect or Orsense NMB200). We assessed sensitivity; specificity; proportion who would have been inappropriately bled, or rejected from donation ("deferred") incorrectly; and test preference. RESULTS: Compared with the reference standard, the methods ranged in test sensitivity from 17.0% (MBR Haemospect) to 79.0% (portable haemoglobinometry) in men, and from 19.0% (MBR Haemospect) to 82.8% (portable haemoglobinometry) in women. For specificity, the methods ranged from 87.2% (MBR Haemospect) to 99.9% (NHSBT's customary method) in men, and from 74.1% (Orsense NMB200) to 99.8% (NHSBT's customary method) in women. The proportion of donors who would have been inappropriately bled ranged from 2.2% in men for portable haemoglobinometry to 18.9% in women for MBR Haemospect. The proportion of donors who would have been deferred incorrectly with haemoglobin concentration above the minimum threshold ranged from 0.1% in men for NHSBT's customary method to 20.3% in women for OrSense. Most donors preferred non-invasive spectrometry. CONCLUSION: In the largest study reporting head-to-head comparisons of four methods to measure haemoglobin prior to blood donation, our results support replacement of NHSBT's customary method with portable haemoglobinometry.

Hemoglobin point-of-care testing in rural Gambia: Comparing accuracy of HemoCue and Aptus with an automated hematology analyzer.

BACKGROUND: Anemia is one of the most impactful nutrient deficiencies in the world and disproportionately affects children in low-resource settings. Point-of-care devices (PoCDs) measuring blood hemoglobin (Hb) are widely used in such settings to screen for anemia due to their low cost, speed, and convenience. Here we present the first iteration of Aptus, a new PoCD which measures Hb and hematocrit (HCT). AIM: To evaluate the accuracy of Aptus and HemoCue® Hb 301 against an automated hematology analyzer (Medonic®) in Gambian children aged 6-35 months and the Aptus' usage in the field. METHODS: Aptus, HemoCue® and Medonic® were compared using venous blood (n = 180), and Aptus and HemoCue® additionally using capillary blood (n = 506). Agreement was estimated using Bland-Altman analysis and Lin's concordance. Usage was assessed by error occurrence and user experience. RESULTS: Mean Hb values in venous blood did not significantly differ between Aptus and HemoCue® (10.44±1.05 vs 10.56±0.93g/dl, p>0.05), but both measured higher Hb concentrations than Medonic® (9.75±0.99g/dl, p<0.0001). Lin's coefficient between Aptus and Medonic® was rc = 0.548, between HemoCue® and Medonic® rc = 0.636. Mean bias between the PoCDs venous measurements was -0.11g/dl with limits of agreement (LoA) -1.63 and 1.40g/dl. The bias was larger for the comparisons between the Medonic® and both Aptus (0.69g/dl, LoA 0.92 and 2.31g/dl) and HemoCue® (0.81g/dl, LoA 0.17 and 1.78g/dl). ROC curves showed an AUC of 0.933 in HemoCue® and 0.799 in Aptus. Capillary Hb was higher with Aptus than HemoCue® (10.33±1.11g/dl vs 10.01±1.07g/dl, p<0.0001). Mean bias was 0.32g/dl with LoA of -1.91 and 2.54g/dl. Aptus' usage proved intuitive, yet time-to-results and cuvettes could be improved. CONCLUSION: Both PoCDs showed a relatively limited bias but large LoA. Aptus and HemoCue® showed similar accuracy, while both overestimated Hb levels. Aptus showed promise, with its operation unimpaired by field conditions as well as being able to show HCT values.

A Pitfall in HbA1c Testing Caused by Hb Long Island Hemoglobin Variant.

BACKGROUND: Although many factors may interfere with hemoglobin (Hb)A1c measurement, Hb variants are among the most important factors. METHODS: We tested the HbA1c levels of the patient, a 32 year old Manchu Chinese woman, during a routine health check. We used different methods, including high-performance liquid chromatography (HPLC) and capillary electrophoresis, to test specimens from the patient. Next, we tested the specimen further using polymerase chain reaction (PCR) and sequencing. RESULTS: We discovered that our patient, who had an HbA1c value of 0, also has an Hb variant, Hb Long Island, which we found during the HbA1c analysis as part of her routine health check at the Health Management Center in the General Hospital of Tianjin Medical University, Tianjin, China. Also, we discovered that the exon 1 of ß gene contained transversion mutations, with 1 heterozygous and 1 homozygous variant (HBB:c.8A > C, 9T > C). These gene mutations resulted in an amino-acid change (His to Pro) and a decrease in HbA1c value. CONCLUSIONS: When there is no correlation between the clinical signs, glycemic status, and glycated Hb levels of the patient, the chromatogram of HbA1c should be carefully checked to detect possible variants that cause interference in the measurement.

Comparison of Hemoglobin Measurements by 3 Point-of-Care Devices With Standard Laboratory Values and Reliability Regarding Decisions for Blood Transfusion.

BACKGROUND: We compared the accuracy of 3 point-of-care testing (POCT) devices with central laboratory measurements and the extent to which between-method disagreements could influence decisions to transfuse blood. METHODS: Hemoglobin concentrations [Hb] were measured in 58 adult patients undergoing cardiothoracic surgery using 2 Ilex GEM Premier 3500 blood gas analyzers (BG_A and BG_B) and a HemoCue Hb-201 device (HemoCue). Measurements were compared with our central laboratory's Siemens Advia 2120 flow cytometry system (laboratory [Hb] [Lab[Hb]]), regarded as the gold standard. We considered that between-method [Hb] differences exceeding 10% in the [Hb] range 6-10 g/dL would likely erroneously influence erythrocyte transfusion decisions. RESULTS: The 70 Lab[Hb] measurements ranged from 5.8 to 16.7 g/dL, of which 25 (36%) were <10.0 g/dL. Measurements by all 4 devices numbered 57. Mean POCT measurements did not differ significantly (P > .99). Results of the Bland-Altman analyses revealed statistically significant bias, with predominant underestimations by all 3 POCTs predominating. HemoCue upper and lower limits of agreement (LOA) were narrower, and the 95% confidence intervals (95% CIs) of the LOAs did not overlap with those of BG_A and BG_B. Similarly, a narrow mountain plot demonstrated greater precision for the HemoCue. Comparing BG_A with BG_B revealed no bias and narrow LOA. Error grid analysis within the [Hb] range 6-10 g/dL revealed that 5.3% of HemoCue measurements were beyond the permissible 10.0% error zone in contrast to 19.0% and 16.0% of the blood gas measurements. Possible inappropriate transfusion decisions based on POCT values generally erred toward unnecessary transfusions. Calculations of Cohen κ statistic indicated better chance-corrected agreement between HemoCue and Lab[Hb] regarding erythrocyte transfusions than the blood gas analyzers. CONCLUSIONS: All 3 POCT devices underestimated the Lab[Hb] and cannot be used interchangeably with standard laboratory measurements. BG_A and BG_B can be considered to be acceptably interchangeable with each other. Whereas the HemoCue had little bias and good precision, the blood gas analyzers revealed large bias and poor precision. We conclude that the tested HemoCue provides more reliable measurements, especially within the critical 6-10 g/dL range, with reduced potential for transfusion errors. Decisions regarding erythrocyte transfusions should also be considered in the light of clinical findings.

Assessing the Association Between Blood Loss and Postoperative Hemoglobin After Cesarean Delivery: A Prospective Study of 4 Blood Loss Measurement Modalities.

BACKGROUND: Visual estimation and gravimetric methods are commonly used to quantify the volume of blood loss during cesarean delivery (CD). However, the correlation between blood loss and post-CD hemoglobin (Hb) is poorly studied, and it is unclear whether the correlation varies according to how blood loss is measured. METHODS: After obtaining Institutional Review Board approval, we performed a prospective study of 61 women undergoing CD to assess the relations between post-CD Hb and blood loss measured using 4 modalities: gravimetric blood loss measurement (gBL), visual blood loss estimation by a blinded obstetrician (oBL) and anesthesiologist (aBL), and the Triton System (tBL). Hb was measured preoperatively and within 10 minutes after CD. gBL was quantified as blood volume in a suction canister in addition to the weight of blood-soaked sponges. tBL was measured with the Triton System by photographing blood-soaked sponges and suction canister contents. To assess the relation between blood loss and post-CD Hb, we performed correlation analyses and compared the magnitude of the correlations across the 4 measurement modalities using William t test. A Bonferroni correction was set to identify a statistically significant correlation (P < .0125) and statistically significant differences between correlation coefficients (P < .008). RESULTS: The mean (standard deviation) preoperative Hb was 12 (1.1) g/dL and post-CD Hb was 11.3 (1.0) g/dL. Median (interquartile range) values for gBL, oBL, aBL, and tBL were 672 mL (266-970), 700 mL (600-800), 750 mL (600-1000), and 496 mL (374-729), respectively. A statistically significant but weak correlation was observed between tBL and post-CD Hb (r = -0.33; P = .01). No statistically significant correlations were observed among aBL (r = -0.25; P = .06), oBL (r = -0.2; P = .13), and gBL (r = -0.3; P = .03) with post-CD Hb. We did not detect any significant differences between any 2 correlation coefficients across the 4 modalities. CONCLUSIONS: Given that we observed only weak correlations between each modality with post-CD Hb and no significant differences in the magnitude of the correlations across the 4 modalities, there may be limited clinical utility in estimating post-CD Hb from blood loss values measured with any of the 4 modalities.

Replicating measurements of total hemoglobin mass (tHb-mass) within a single day: precision of measurement; feasibility and safety of using oxygen to expedite carbon monoxide clearance.

Hemoglobin concentration ([Hb]) is a function of total hemoglobin mass (tHb-mass) and plasma volume. [Hb] may fall by dilution due to plasma volume expansion and changes in the perioperative period may therefore correlate poorly with blood loss. A simple, reliable, repeatable way to measure plasma volume and tHb-mass would have substantial clinical utility. The "optimized carbon monoxide re-breathing method" (oCOR) meets these criteria. However, it is recommended that a minimum of 12 h (when breathing room air) is left between repeat measurements. Twenty-four subjects underwent 3 days of testing. Two oCOR tests were performed (T1 and T2), 3 h apart, with a different CO clearance method employed between tests aiming to keep the carboxyhemoglobin level below 10%. The primary aim was to ascertain whether tHb-mass testing could be safely repeated within 3 h if carboxyhemoglobin levels were actively reduced by breathing supplemental oxygen (PROCA ). Secondary aims were to compare two other clearance methods; moderate exercise (PROCB ), or a combination of the two (PROCC ). Finally, the reliability of the oCOR method was assessed. Mean (SD) tHb-mass was 807.9 ± (189.7 g) (for T1 on day 1). PROCA lowered the carboxyhemoglobin level from the end of T1 (mean 6.64%) to the start of T2 (mean 2.95%) by a mean absolute value of 3.69%. For PROCB and PROCC the mean absolute decreases in carboxyhemoglobin were 4.00% and 4.31%, respectively. The fall in carboxyhemoglobin between T1 and T2 was greatest in PROCC ; this was statistically significantly lower than that of PROCA (P = 0.0039) and PROCB (P = 0.0289). The test-retest reliability for the measurement of total hemoglobin mass was good with a mean typical error (TE) of 2.0%. The oCOR method is safe and can be repeated within 3 h when carbon monoxide is suitably cleared between tests. Using oxygen therapy alone adequately achieves this.

Determination of hemoglobin mass in humans by measurement of CO uptake during inhalation of a CO-air mixture: a proof of concept study.

Measuring hemoglobin mass (Hbmass) using the carbon monoxide (CO) bolus rebreathing method is frequently used in research but has yet to be widely used in the clinical practice. The estimation of an adequate CO bolus may be difficult in patients with unknown Hbmass. In the present pilot study, a progressive inhalation technique for CO that leads to a linear individual adjusted COHb increase was evaluated. Sixteen healthy test subjects participated in the study (preliminary investigation: six; main study: ten). The reliability and validity of the new method were evaluated using multiple measurements of Hbmass with and without a defined blood donation and compared to a CO bolus method. The participants inhaled a CO-air mixture (CO concentration: 1500 ppm) for a specific breathing duration. The CO uptake and COHb change were determined simultaneously. The typical error (reliability) in the repeated measurements was 2.4% (CI ± 4.7). The mean difference between the new method and the bolus method was 34 g (±41; P = 0.026). The measured hemoglobin loss in 490 mL of blood was 74 g (±35), and the calculated hemoglobin loss was 77 g (±4) (mean difference 3 g ± 34; P = 0.820). The new method was reliable and valid in a proof of concept study with healthy subjects. The total amount of CO and as a result the COHb increase is individually adjustable. Future studies in clinical settings are needed to determine if the method could be used in disease-specific pathologies associated with changes in Hbmass.

The impact of analytical variation of hemoglobin measurement on blood donors' hemoglobin and deferral rates.

BACKGROUND: Donors' hemoglobin (Hb) level must be tested before blood donation. Low Hb is the leading reason for donor deferral. Many donor-related and external factors associated with low Hb are known, but no studies have been conducted concerning the effects of analytical variation on donor Hb measurements and deferrals. STUDY DESIGN AND METHODS: The effects of donors' age, the seasonal and daily distribution of donations, and batch-to-batch variation in HemoCue Hb 201+ cuvettes on donors' capillary Hb (cHb) measurements and deferrals were analyzed for more than 1.7 million donor visits in 2010 to 2016 at a national blood establishment. Furthermore, approximately 3.1 million cHb measurements from the years 2000 to 2009 were included in analyses to correlate measured cHb value and Hb deferral rate. RESULTS: A significant correlation between the mean annual cHb and Hb deferral rate was observed in both women and men. The season of the donation was the strongest explanatory factor for the monthly variation of predonation cHb (explaining 25 and 31% of the variation in women and men, respectively). Batch-to-batch variation in HemoCue cuvettes explained 6.8% of monthly variation in women and 7.4% in men. Monthly changes in donors' age distribution explained 2.5% of monthly variation in women and 2.4% in men. CONCLUSION: Small and, in most clinical settings, negligible analytical variation in Hb measurement methods can have significant consequences when used for Hb screening of blood donors. This should be minimized by using methods in which analytical variation is under control and kept as low as possible.

New approach to accurate interpretation of sickle cell disease newborn screening by applying multiple of median cutoffs and ratios.

BACKGROUND: The main goal of newborn screening (NBS) for sickle cell disease (SCD) is to detect affected neonates so that specific preventive care can be implemented. High-performance liquid chromatography (HPLC) used for NBS has high sensitivity and specificity, but we lack guidelines for quantitative hemoglobin (Hb) fraction interpretation. The purpose of this study was to determine cutoff values to standardize quantitative interpretation in SCD NBS for different clinical situation such as, red blood cell transfusion or beta-thalassemia, which can be real screening pitfalls. METHODS: Retrospective study of 75,026 samples from the neonatal screening program analyzed in our laboratory. Precise HbA and HbS percentages at birth were recorded and median values established for each gestational age, allowing percentage results to be expressed in normal gestation-specific multiples of the median (MoM). Three threshold values of clinical interest were determined. RESULTS: High levels of HbA (>2.5 MoM) allowed identification of newborns who received transfusions. Low levels of HbS (≤0.7 MoM) allowed detection of the association between HbS and other mutations of the beta-globin gene (i.e., HbHope, ß0-thalassemia, etc.). An HbA/HbS ratio <0.5 to distinguish healthy carriers from SCD with S/ß+-thalassemia. The screening accuracy for each threshold was established. The screening accuracy of low-level HbA, which is determinant in identifying the subgroup of patients at risk of ß-thalassemia, will be determined prospectively. CONCLUSIONS: This new approach introduces tools for a quantitative interpretation in SCD NBS by HPLC methods and could allow standardization of interpretation between centers.

Hemoglobin S monitoring on TOSOH G8 in hemoglobin A1c mode in case of urgent red blood cell exchange.

BACKGROUND: Pre- and post-transfusion hemoglobin S (HbS) levels are used to document the efficacy of red blood cell exchange (RCE) in patients with sickle cell disease (SCD). In case of urgent RCE a 24/7 short turn-around time (STAT) analysis, with the ability to identify and quantify HbS, is warranted. The use of TOSOH G8 (Tosoh Europe) is evaluated for this purpose, using the variant HbA1c mode. METHODS: Analytical performance of the HbS analysis on TOSOH G8 in variant HbA1c mode was evaluated, including assessment of imprecision and linearity for HbS. In addition, a comparison study between TOSOH G8 and Minicap Flex Piercing (FP) system CZE (Sebia) using 32 HbS samples (HbS range: 9%-93%) was carried out to evaluate analytical and clinical concordance. RESULTS: Total HbS imprecision was 1.77% and 0.31% for a sickle cell trait and a sickle cell anemia sample, respectively. An acceptable linearity (HbS range: 6%-88%) was observed (R2  > .99). Passing-Bablok regression analysis showed a significant proportional bias; however, a good analytical concordance (r > .95) was found. Our results suggested that TOSOH G8 underestimated HbS results compared with those of Minicap FP system (mean difference: -3.54%), especially in samples with a high HbS concentration. CONCLUSION: Hemoglobin S results obtained with TOSOH G8 in variant HbA1c mode are clinically acceptable to monitor urgent RCE. The observed underestimation will not alter clinical decision-making.

Guidance for faecal occult blood testing: quantitative immunochemical method (FIT-HB) in colorectal cancer screening programmes. / Guida per la determinazione del sangue occulto fecale: metodo immunochimico quantitativo (FIT-HB) nei programmi di screening per il carcinoma colorettale

BACKGROUND: in Italy, colorectal cancer screening is included as part of the Italian National Health Service - SSN (Servizio Sanitario Nazionale) Essential Levels of Care - LEA (Livelli Essenziali Assistenziali) and the European Guidelines, which specify quantitative FIT-Hb testing as the best strategy for organised screening programmes. To ensure consistent operating standards in Member States, European regulations require the implementation of certification and accreditation requirements for diagnostic and care-related processes. The requirement, based on ISO 17021 accreditation standards, includes ISO 9001 certification for systems and ISO 15189:2012 accreditation for laboratories. METHODOLOGY: various phases of the analytical process (pre-test, test, post-test) were evaluated in detail and provided operational guidelines for adjusting analytical and managerial procedures using: (a) feedback from members of GISCoR screening labs; (b) performance data obtained via a systematic review of the literature and the Osservatorio Nazionale Screening (ONS) Survey; (c) recommendations for laboratory practice issued by the World Endoscopy Organization "FIT for Screening" Working Group; (d) selected guidelines from the National Guidelines Clearinghouse database; and (e) Canadian, Australian and European screening programme websites. With respect to ISO 15189:2012 standards for accreditation of medical laboratories, GISCoR's guidance has been re-evaluated and revised by auditors from the Italian certification body (ACCREDIA) to assess its compliance and completeness with the aim of finalising operating procedures. CONCLUSIONS: the implementation and maintenance of operational standards required by complex systems (e.g. screening programmes) involving constant interaction between facilities and the supporting organisational structure are not easy to achieve. The guide aims to provide laboratories with the necessary guidance for proper process management.

Variation in haemoglobin measurement across different HemoCue devices and device operators in rural Cambodia.

: Point-of-use haemoglobinometers, such as the HemoCue, are a common method to measure haemoglobin (Hb) concentration in field settings as the device is portable, requires only a small finger-prick capillary blood sample and computes an immediate Hb reading. The aim of this study was to compare Hb measurements across different HemoCue devices and across device operators using capillary blood samples collected from women during a trial in rural Cambodia. We compared mean±SD capillary Hb concentration (g/L) across n=12 different HemoCue Hb 301 devices and across n=9 device operators among 2846 Cambodian women. Significant variability in mean Hb concentration was observed across HemoCue devices (means ranged from 117 to 124 g/L) and across device operators (means ranged from 118 to 124 g/L). This variability is of particular concern when a single HemoCue device or device operator is used at different time points in surveys or research trials. TRIAL REGISTRATION NUMBER: NCT02481375.

Validation of Masimo Pronto 7 and HemoCue 201 for hemoglobin determination in children from 1 to 5 years of age.

OBJECTIVE: To evaluate the accuracy and precision of HemoCue 201 (HemoCue) and Masimo Pronto 7 (Masimo) devices for measuring hemoglobin (Hb) in epidemiological studies, having venous blood samples as a gold standard. MATERIAL AND METHODS: We measured Hb concentrations in a field sample of 148 children from one to five years of age. Masimo and HemoCue were used for capillary blood samples and an automatic analyzer for venous blood samples. Regression models with no intercept were constructed to measure precision and predictability, concordance correlations to measure accuracy and precision, and Bland-Altman limits of agreement as well as hierarchical linear models to estimate variance. RESULTS: Both HemoCue and Masimo underestimated Hb concentrations compared to the gold standard. They respectively yielded the following results: regression coefficients of 0.887 and 0.876 with 98.7% and 98.6% predictability; concordance correlation coefficients of 0.183 (p<0.001) and 0.166 (p<0.001); and Bland-Altman variances of -1.51 and -1.62. With regard to Masimo specifically, the three-level Hierarchical Linear Model showed that 57.9% of total variance stemmed from random errors in repeated measures from the same subject. CONCLUSIONS: HemoCue and Masimo measure lower Hb concentrations than the gold standard. Their accuracy and precision levels are comparable. It is essential to ensure proper use of devices through enhanced training of field workers.

Analysis of HbA1c on an automated multicapillary zone electrophoresis system.

Hemoglobin A1c (HbA1c) is a frequently requested laboratory test and there is thus a need for high throughput instruments for this assay. We evaluated a new automated multicapillary zone electrophoresis instrument (Capillarys 3 Tera, Sebia, Lisses, France) for analysis of HbA1c in venous samples. Routine requested HbA1c samples were analyzed immunologically on a Roche c6000 instrument (n = 142) and then with the Capillarys 3 Tera instrument. The Capillarys 3 Tera instrument performed approximately 70 HbA1c tests/hour. There was a strong linear correlation between Capillarys 3 Tera and Roche Tina-Quant HbA1c Gen 3 assay (y = 1.003x - 0.3246 R2 = .996). The total CV for the 12 capillaries varied between 0.8 and 2.2% and there was a good agreement between duplicate samples (R2 = .997). In conclusion, the Capillarys 3 Tera instrument has a high assay capacity for HbA1c. It has a good precision and agreement with the Roche Tina-Quant HbA1c method and is well suited for high volume testing of HbA1c.

Can the Afinion HbA1c Point-of-Care instrument be an alternative method for the Tosoh G8 in the case of Hb-Tacoma?

BACKGROUND: Hb-variant interference when reporting HbA1c has been an ongoing challenge since HbA1c was introduced to monitor patients with diabetes mellitus. Most Hb-variants show an abnormal chromatogram when cation-exchange HPLC is used for the determination of HbA1c. Unfortunately, the Tosoh G8 generates what appears to be normal chromatogram in the presence of Hb-Tacoma, yielding a falsely high HbA1c value. The primary aim of the study was to investigate if the Afinion HbA1c point-of-care (POC) instrument could be used as an alternative method for the Tosoh G8 when testing for HbA1c in the presence of Hb-Tacoma. METHODS: Whole blood samples were collected in K2EDTA tubes from individuals homozygous for HbA (n = 40) and heterozygous for Hb-Tacoma (n = 20). Samples were then immediately analyzed with the Afinion POC instrument. After analysis, aliquots of each sample were frozen at -80 °C. The frozen samples were shipped on dry ice to the European Reference Laboratory for Glycohemoglobin (ERL) and analyzed with three International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and National Glycohemoglobin Standardization Program (NGSP) Secondary Reference Measurement Procedures (SRMPs). The Premier Hb9210 was used as the reference method. RESULTS: When compared to the reference method, samples with Hb-Tacoma yielded mean relative differences of 31.8% on the Tosoh G8, 21.5% on the Roche Tina-quant Gen. 2 and 16.8% on the Afinion. CONCLUSIONS: The Afinion cannot be used as an alternative method for the Tosoh G8 when testing for HbA1c in the presence of Hb-Tacoma.

Hemorragia posparto tardía y utilidad de la determinación no invasiva de hemoglobina: comunicación de un caso / Secondary postpartum hemorrhage and usefulness of non-invasive hemoglobin determination: a case report

Una de las principales causas de morbimortalidad en la mujer gestante es el sangrado que se produce tras el parto. La hemorragia posparto tardía (HPT) es aquel sangrado excesivo que se produce entre las 24 h posteriores al parto y las 12 semanas. Sus causas son multifactoriales y, aunque con frecuencia no compromete la vida de la paciente, puede llegar a hacerlo. Una vez diagnosticada, es necesario un tratamiento rápido y multidisciplinar, restaurando el volumen y monitorizando la respuesta al tratamiento. Presentamos el caso de una paciente que sufrió una HPT en la que se objetivó, tras ser transfundida, la persistencia de anemia mediante determinación de hemoglobina total continua utilizando un cooxímetro de pulso, iniciando la reposición de volumen y hemoderivados ayudados por dicha tecnología. El cuadro se resuelve tras suturar en quirófano un seudoaneurisma de la arteria uterina izquierda responsable de la hemorragia, evolucionando la paciente satisfactoriamente (AU)

One of the major causes of morbidity and mortality in pregnant women is bleeding after childbirth. Secondary postpartum hemorrhage consists of excessive bleeding occurring between 24 hours and 12 weeks after delivery. Its causes are multifactorial and, although it is rarely life threatening, serious risks may arise. When diagnosed, rapid multidisciplinary treatment is necessary to restore blood volume and monitor treatment response. We report the case of a patient who developed secondary postpartum hemorrhage. After transfusion, determination of continuous total haemoglobin by pulse co-oximetry revealed persistent anemia. Consequently, blood volume replacement was initiated. The case was resolved after surgical suturing of a pseudoaneurysm of the left uterine artery, which had caused the bleeding. The patient subsequently made a good recovery (AU)

Complete blood count at the ED: preanalytic variables for hemoglobin and leukocytes.

OBJECTIVE: The objective of this study is to determine the ways in which preanalytic factors related to physiologic status can affect the complete blood cell count (CBC) in patients referring to an emergency department (ED). METHODS: Over a 1-year period, the results of hemoglobin (Hb) level and white blood cell (WBC) counts of the first CBC tests undertaken in consecutive patients (n = 11487) referring to the ED were compared with those obtained in the same patients at a second test undertaken within 24 hours of admission. A prospective evaluation of the same differences was made in another group (group 2) of 1025 consecutive ED patients, several clinical characteristics being taken into consideration. RESULTS: Mean Hb concentrations were higher in the first (range, 8.0-15.9 g/dL) than in the second test results (median overestimation, 0.4-0.8 g/dL; P < .0001). At multivariate analysis of results in group 2 patients, fluid administration (>0.5 L) and the presence of edema played a significant role in the initial overestimation of Hb level (P = .001 and P = .045, respectively). The comparison between leukocyte counts (WBC) showed that values from the first were higher than those in the second test (median overestimation ranging from 0.42 to 3.63 × 10(9)/L cells, in the range counts from 4.0 to 30.0 × 10(9)/L). None of the clinical factors studied appeared to have affected this overestimation. CONCLUSIONS: On interpreting CBC results in patients admitted to the ED, physicians must consider the effect of physiologic variables on Hb level (mainly hydration status) and WBC count (mental and physical stress).

Impact of preanalytical factors on fecal immunochemical tests: need for new strategies in comparison of methods.

BACKGROUND: Harmonization of fecal immunochemical tests for hemoglobin (FIT-Hb) is crucial to compare clinical outcomes in screening programs. The lack of reference materials and standard procedures does not allow the use of usual protocols to compare methods. We propose 2 protocols, based on artificial biological samples (ABS), to discriminate preanalytical and analytical variation and investigate clinical performances. The protocols were used to compare 2 FIT systems available on European markets: the OC-Sensor Diana (Eiken, Tokyo, Japan) and HM-JACKarc (Kyowa-Medex, Tokyo, Japan). METHODS: ABS were obtained adding Hb to Hb-free feces. In the first procedure, 35 ABS were collected for each collection device and analyzed on both systems. In the second, 188 ABS (106 positive and 82 negative) were -collected and tested on the specific systems. Passing-Bablock (PB), Pearson's correlation coefficients (R) and Bland-Altman difference analysis were used to compare data. RESULTS: PB, R and mean standard errors for Bland-Altman analysis (Diana vs. Arc) results were 0.93x-0.56: R = 0.97 and 19%; and 1.09x + 5.60: R = 0.96 and -18%; for Diana and Arc devices, respectively. No correlations and no difference in positive/negative assessment were observed with the second protocol. CONCLUSIONS: A good correlation was observed in comparing data generated using collection devices on the 2 systems. Manufacturers have developed different sample collection procedures for feces: therefore, data from different systems cannot easily be compared. Adoption of protocols to discriminate preanalytical and analytical variation would be a significant contribution to harmonization of FIT, facilitating data comparison and information acquisition for sample collection strategy and effect of buffers on systems.