Assessing Accuracy and Precision of Hemoglobin Determination in Venous, Capillary Pool, and Single-Drop Capillary Blood Specimens Using three Different HemoCue® Hb Models: The Multicountry Hemoglobin Measurement (HEME) Study.

BACKGROUND: Anemia prevalence estimates reported in population surveys can vary based on the blood specimen source (capillary or venous) and analytic device (hematology autoanalyzers or portable hemoglobinometers) used for hemoglobin (Hb) determination. OBJECTIVES: This study aimed to compare accuracy and precision of Hb measurement in three blood specimen types on three models of hemoglobinometers against the results from venous blood from the same individuals measured on automated analyzers (AAs). METHODS: This multisite (Cambodia, Ethiopia, Guatemala, Lebanon, Nigeria, and Tanzania) study assessed Hb measurements in paired venous and capillary blood specimens from apparently healthy women (aged 15-49 y) and children (aged 12-59 mo) using three HemoCue® Hb models (201+, 301, and 801). Measurements were compared against reference values: venous blood in hematology AA and adjusted via regression calibration or mean difference in HemoCue® Hb. Venous, capillary pool, and single-drop capillary blood specimens were assessed for accuracy and precision. RESULTS: Venous blood measured using HemoCue® Hb 301 exhibited a positive mean error, whereas responses in HemoCue® Hb 201+ and 801 were nondirectional compared with the reference. Adjustment with the reference harmonized mean errors for all devices across study sites to <1.0 g/L using venous blood. Precision was highest for venous blood (±5-16 g/L) in all sites, lowest for single-drop capillary (±9-37 g/L), and intermediate (±9-28 g/L) for capillary pool blood specimen. Imprecision differed across sites, especially with both capillary blood specimens, suggesting different levels of personnel skills. CONCLUSIONS: Findings suggest that venous blood is needed for accurate and precise Hb determination. Single-drop capillary blood use should be discouraged owing to high measurement variability. Further research should evaluate the viability and reliability of capillary pool blood for this purpose. Accuracy of HemoCue® Hb devices can be improved via standardization against results from venous blood assessed using AA.

Baseline haemoglobin variability by measurement technique in pregnant people on the day of childbirth.

Point-of-care haemoglobin measurement devices may play an important role in the antenatal detection of anaemia in pregnant people and may be useful in guiding blood transfusion during resuscitation in obstetric haemorrhage. We compared baseline haemoglobin variability of venous and capillary HemoCue® haemoglobin, and Masimo® Rad-67 Pulse CO-Oximeter haemoglobin with laboratory haemoglobin in people on the day of their planned vaginal birth. A total of 180 people undergoing planned vaginal birth were enrolled in this prospective observational study. Laboratory haemoglobin was compared with HemoCue and Masimo Rad-67 Pulse CO-Oximeter measurements using Bland-Altman analysis, calculating mean difference (bias) and limits of agreement. Five (2.8%) people had anaemia (haemoglobin < 110 g.l-1 ). Laboratory haemoglobin and HemoCue venous haemoglobin comparison showed an acceptable bias (SD) 0.7 (7.54) g.l-1 (95%CI -0.43-1.79), with limits of agreement -14.10-15.46 g.l-1 and acceptable agreement range of 29.6 g.l-1 . Laboratory and HemoCue capillary haemoglobin comparison showed an unacceptable bias (SD) 13.3 (14.12) g.l-1 (95%CI 11.17-15.34), with limits of agreement - 14.42-40.93 g.l-1 and unacceptable agreement range of 55.3 g.l-1 . Laboratory and Masimo haemoglobin comparison showed an unacceptable bias (SD) -14.0 (11.15) g.l-1 (95%CI -15.63 to -12.34), with limits of agreement to -35.85 to 7.87 g.l-1 and acceptable agreement range of 43.7 g.l-1 . Venous HemoCue, with its acceptable bias and limits of agreement, should be applied more widely in the antenatal setting to detect, manage and risk stratify pregnant people with anaemia. HemoCue capillary measurement under-estimated haemoglobin and Masimo haemoglobin measurement over-estimated, limiting their clinical use. Serial studies are needed to determine if the accuracy of venous HemoCue haemoglobin measurement is sustained in other obstetric settings.

Evaluation of the use of non-invasive hemoglobin measurement in early childhood.

BACKGROUND: Iron deficiency anemia in children affects psychomotor development. We compared the accuracy and trend of a non-invasive transcutaneous spectrophotometric estimation of arterial hemoglobin (Hb) concentration (SpHb) by rainbow pulse CO-oximetry technology to the invasive blood Hb concentration measured by an automated clinical analyzer (Hb-Lab). METHODS: We measured the SpHb and Hb-Lab in 109 patients aged 1-5 years. Regression analysis was used to evaluate differences between the two methods. The bias, accuracy, precision, and limits of agreement of SpHb compared with Hb-Lab were calculated using the Bland-Altman method. RESULTS: Of the 109 enrolled subjects, 102 pairs of the SpHb and Hb-Lab datasets were collected. The average value of measured Hb was 12.9 ± 1.03 (standard deviation [SD]) g/dL for Hb-Lab. A significant correlation was observed between SpHb and Hb-Lab measurements (SpHb = 7.002 + 0.4722 Hb-Lab, correlation coefficient r = 0.548, 95% confidence interval = 0.329-0.615). Bland-Altman analysis showed good visual agreement, with a mean bias between SpHb and Hb-Lab of 0.188 ± 0.919 g/dL (mean ± SD). CONCLUSIONS: We concluded that non-invasive Hb measurement is useful for Hb estimation in children and provides new insights as a screening tool for anemia. IMPACT: Our results indicated a good correlation between non-invasive transcutaneous spectrophotometric estimation of arterial hemoglobin (Hb) concentration using a finger probe sensor by rainbow pulse CO-oximetry technology and invasive blood Hb concentration. Although previous studies have indicated that in patients with a worse condition, the bias between the two methods was large, this study, which was conducted on children with stable disease, showed a relatively small bias. Further studies using this non-invasive device might help to understand the current status of anemia in Japan and promote iron intake and nutritional management in children.

Comparison between a laser lancing device and lancet for capillary blood sampling, capillary blood hemoglobin measurement, and blood typing.

BACKGROUND: Blood donor screening includes tests using capillary blood, which is usually obtained by finger pricking using a lancet; however, the lancet has some shortcomings, such as skin puncture pain and needle stick injury. Recently, laser lancing devices for finger-prick sampling have been developed. We compared capillary blood Hb (cHb) levels and blood typing results obtained using a laser lancing device with those obtained using a lancet. STUDY DESIGN AND METHODS: cHb levels, blood typing results, and skin puncture pain scores were assessed in 191 participants. Finger-prick sampling was performed using LMT-1000 (LaMeditech, Seoul, Korea) and a lancet on the same finger on different hands. Paired venous Hb (vHb) levels were assessed in 103 participants using an automated hematology analyzer and compared with the cHb levels obtained using both lancing devices. RESULTS: The paired cHb results obtained with the laser lancing device and lancet showed a strong correlation (r = 0.927, p < .001) without any significant difference (p = .113) and a substantial agreement (κ = 0.654) for the identification of participants with a low Hb level (<12.5 g/dl). cHb levels were significantly higher than vHb levels with both lancing devices (mean differences: 0.27-0.43 g/dl). The results of blood typing using the laser lancing device showed 100% accuracy. Use of the laser lancing device showed significantly lower skin puncture pain scores (p < .001). CONCLUSION: Use of a laser lancing device for capillary Hb measurement and blood typing showed accurate results, with significantly reduced skin puncture pain. Laser lancing devices could be feasible for donor screening tests.

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.

The usefulness of non-invasive co-oximetry haemoglobin measurement for screening pre-operative anaemia.

Pre-operative anaemia (haemoglobin < 13.0 g.dl-1 ) is a modifiable peri-operative risk-factor. This is screened for using formal laboratory testing. A non-invasive finger-probe sensor that can accurately measure haemoglobin is a possible alternative. This study considers the accuracy of non-invasive haemoglobin measurement using the Rad-67™ Rainbow (Masimo Corp., Irvine, CA, USA) compared with formal laboratory testing and its usefulness in detecting pre-operative anaemia. A total of 392 patients had measurements taken for non-invasive haemoglobin and perfusion index values using the Rad-67 Rainbow, alongside further peri-operative parameters and a formal laboratory haemoglobin test. Bland-Altman and sensitivity analysis showed that the limits of agreement between non-invasive and formal laboratory haemoglobin testing were between -1.95 g.dl-1 and 2.23 g.dl-1 (p < 0.001). The overall performance of non-invasive haemoglobin measurement was better in men than women (ROC 91.1% vs. 78.2%) and less biased in men, mean -0.08 (SD 1.09, 95%Cl -0.23-0.07) compared with women (mean 0.38 (SD 0.99, 95%CI 0.24-0.52)). Pre-operative anaemia was more prevalent in women than men (50.3% vs. 14.4%). The sensitivity of non-invasive anaemia detection (haemoglobin < 13 g.dl-1 ) was 66% for women and 52% for men. A non-invasive haemoglobin value of 14.0 g.dl-1 had an overall 91% sensitivity for detecting pre-operative anaemia (82% in men and 93% in women). The Rad-67 Rainbow is inadequate for the estimation of formal laboratory haemoglobin and lacks sensitivity for detecting pre-operative anaemia, especially in women. Further advancement in technology and accuracy is needed before it can be recommended as a routine pre-operative screening test.

Clinical implications of using non-invasive haemoglobin monitoring for red blood cell transfusion decision in hip arthroplasty.

INTRODUCTION: The decision to transfuse red blood cells requires accurate haemoglobin concentration values. In this study, we evaluated if continuous non-invasive haemoglobin (SpHb) measurement could substitute laboratory determined haemoglobin (LabHb) in patients undergoing elective hip replacement. As secondary objective, we analyzed the trend of the difference between techniques. MATERIALS/METHODS: LabHb measurements were done using an automated analyser and SpHb measurements were acquired using Radical-7®. In randomly selected patients undergoing hip replacement, whenever blood was collected for LabHb, concomitant SpHb was recorded. Correlation, bias and accuracy of SpHb were calculated in comparison with LabHb. RESULTS: 108 paired measurements were obtained from 43 patients. The Pearson R of the correlation between SpHb and LabHb was 0.7 (p < 0.001). Bland-Altman test revealed a bias of 1 ± 1.4 g dL-1, meaning Lab Hb was recurrently higher than SpHb. Limits of agreement were [-1.7; 3.8]. Considering RBC transfusion threshold of 8 g dL-1, we found that in two situations transfusion decision would differ based on the measurement considered. Trending ability of SpHb study showed a significant difference between preoperative and postoperative LabHb-SpHb. DISCUSSION: There was a good correlation between SpHb and LabHb, while bias and limits of agreement were higher than those in literature. There was a limited trending ability of SpHb during the perioperative period. Despite this, using SpHb instead of LabHb for decision making regarding transfusion would only change the decision in 1.9 % of our cases. Our findings suggest that this device could be used as a reference but cannot replace venous puncture as gold standard.

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.

Accuracy and trending ability of hemoglobin measurement by the Pulse CO-Oximeter during vascular surgery.

Real time information of Hb concentration can guide a tailored patient blood management. The study investigates the accuracy, precision and trending ability of the Pulse CO-Oximeter (SpHb) and blood gas analyzer in measuring the Hb concentration, compared to hematological analysis, in surgery at high risk of hemorrhage. We performed an observational study, involving 48 patients undergoing abdominal aortic open surgery. The primary endpoints of the study were to compare the accuracy in measuring the Hb concentration using non-invasive method (Masimo rainbow SET® Radical 7 Pulse CO-Oximetry™) compared to the values provided by invasive conventional blood gas analyzer and hematological analysis. The secondary endpoint was to compare the differences between the baseline and the final value of the Hb after surgery (Δ-values), as well as the trending ability. Bias (precision) for the SpHb was 1.63 g/dL (± 0.05) with 95% limits of agreement between 0.85 and + 2.4 g/dL, while for the blood gas analyzer was 0.69 g/dL (± 0.04) with 95% limits of agreement between 0.07 and 1.3 g/dL. Δ-values values were not statistically different from the reference values of ΔHb obtained with the hematological analysis. Trending ability was good for both Pulse CO-Oximeter and blood gas analysis. Our results have shown that the SpHb is not precise enough to replace an invasive approach, but the trending ability of SpHb is accurate and may provide important information on the changes in hemoglobin concentration to guide blood management.

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.

Assessment of haemoglobin measurement by several methods - blood gas analyser, capillary and venous HemoCue® , non-invasive spectrophotometry and laboratory assay - in term and preterm infants.

A laboratory haematology analyser is the gold standard for measuring haemoglobin concentration but has disadvantages, especially in neonates. This study compared alternative blood-sparing and non-invasive methods of haemoglobin concentration measurement with the gold standard. Haemoglobin concentrations were measured using a laboratory haematology analyser (reference method), blood gas analyser, HemoCue® using venous and capillary blood samples and a newly developed non-invasive sensor for neonates < 3 kg. A total of 63 measurements were performed. Body weight (2190 (1820-2520 [967-4450]) g) and haemoglobin concentration (12.3 (10.6-15.2 [8.2-20.5]) g.dl-1 ) varied widely. Bias/limits of agreement between the alternative methods and reference method were -0.1/-1.2 to 1.0 g.dl-1 (blood gas analyser), -0.4/-1.8 to 1.1 g.dl-1 (HemoCue, venous blood), 0.7/-1.9 to 3.2 g.dl-1 (HemoCue, capillary blood) and -1.2/-4.3 to 2 g.dl-1 (non-invasive haemoglobin measurement). Perfusion index, body weight and fetal haemoglobin concentration did not affect the accuracy of the alternative measurement methods, and these were successfully applied in term and preterm infants. However, the accuracies of non-invasive haemoglobin measurement and HemoCue of capillary blood especially lacked sufficient agreement with that of the reference method to recommend these methods for clinical decision making.

Noninvasive Continuous Hemoglobin Monitoring: Role in Cardiovascular Surgery.

Blood transfusions in the operating room are associated with increased morbidity and mortality as well as increased cost. The technology exists for continuous noninvasive hemoglobin monitoring (SpHb), which could allow for the rapid diagnosis and treatment of acute blood loss anemia secondary to surgical bleeding. However, the accuracy of this technology has been called into question. SpHb in the operating room could reduce cost by decreasing lab draws, unnecessary transfusions, and the morbidity associated with blood transfusions. This review examines the accuracy of noninvasive hemoglobin monitoring as well as the role it may play in the operating room.

Detailed view on slow sinusoidal, hemodynamic oscillations on the human brain cortex by Fourier transforming oxy/deoxy hyperspectral images.

Slow sinusoidal, hemodynamic oscillations (SSHOs) around 0.1 Hz are frequently seen in mammalian and human brains. In four patients undergoing epilepsy surgery, subtle but robust fluctuations in oxy- and deoxyhemoglobin were detected using hyperspectral imaging of the cortex. These SSHOs were stationary during the entire 4 to 10 min acquisition time. By Fourier filtering the oxy- and deoxyhemoglobin time signals with a small bandwidth, SSHOs became visible within localized regions of the brain, with distinctive frequencies and a continuous phase variation within that region. SSHOs of deoxyhemoglobin appeared to have an opposite phase and 11% smaller amplitude with respect to the oxyhemoglobin SSHOs. Although the origin of SSHOs remains unclear, we find indications that the observed SSHOs may embody a local propagating hemodynamic wave with velocities in line with capillary blood velocities, and conceivably related to vasomotion and maintenance of adequate tissue perfusion. Hyperspectral imaging of the human cortex during surgery allow in-depth characterization of SSHOs, and may give further insight in the nature and potential (clinical) use of SSHOs.

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.

The Clinical Utility of Noninvasive Pulse Co-oximetry Hemoglobin Measurements in Dark-Skinned Critically Ill Patients.

BACKGROUND: The primary objective of this study was to assess the clinical usefulness of a point-of-care device which measures hemoglobin noninvasively (SpHb) in a group of critically ill participants with dark skin pigmentation. METHODS: One hundred forty-six adult and pediatric participants from a multidisciplinary intensive care unit had intermittent readings of noninvasive hemoglobin measurements performed at a minimum of 4 hourly intervals. A total of 371 readings were analyzed. Concurrent blood samples were taken to assess hemoglobin levels using point-of-care blood gas analyzer, as well as sent to a central laboratory where hemoglobin was measured using the sodium lauryl sulfate method. Bland-Altman plots were constructed to assess the agreement between results from the 2 point-of-care devices with the reference standard (laboratory hemoglobin). RESULTS: SpHb exhibited significant bias when compared to laboratory hemoglobin, while blood gas hemoglobin did not. Mean bias for SpHb was +1.64 with limits of agreement of -1.03 to 4.31 compared to blood gas hemoglobin which showed a bias of 0.26 and limits of agreement of -0.84 to 1.37. The magnitude of the bias for SpHb increased with increasing mean hemoglobin levels. Of all the additional study variables assessed for effect on the bias, only Acute Physiology and Chronic Health Evaluation II score in adult patients (P < .0001) and mean arterial blood pressure (P = .001) had an effect. Skin pigmentation did not have any effect on the magnitude of bias. CONCLUSIONS: Noninvasive Hemoglobin measurement is a promising tool in dark-skinned critically ill patients with low hemoglobin levels, but requires further refinements for it to have clinical usefulness.

In Vitro Evaluation of a Novel Image Processing Device to Estimate Surgical Blood Loss in Suction Canisters.

BACKGROUND: Clinicians are tasked with monitoring surgical blood loss. Unfortunately, there is no reliable method available to assure an accurate result. Most blood lost during surgery ends up on surgical sponges and within suction canisters. A novel Food and Drug Administration-cleared device (Triton system; Gauss Surgical, Inc, Los Altos, CA) to measure the amount of blood present on sponges using computer image analysis has been previously described. This study reports on performance of a complementary Food and Drug Administration-cleared device (Triton Canister System; Gauss Surgical, Inc, Los Altos, CA) that uses similar image analysis to measure the amount of blood in suction canisters. METHODS: Known quantities of expired donated whole blood, packed red blood cells, and plasma, in conjunction with various amounts of normal saline, were used to create 207 samples representing a wide range of blood dilutions commonly seen in suction canisters. Each sample was measured by the Triton device under 3 operating room lighting conditions (bright, medium, and dark) meant to represent a reasonable range, resulting in a total of 621 measurements. Using the Bland-Altman method, the measured hemoglobin (Hb) mass in each sample was compared to the results obtained using a standard laboratory assay as a reference value. The analysis was performed separately for samples measured under each lighting condition. It was expected that under each separate lighting condition, the device would measure the various samples within a prespecified clinically significant Hb mass range (±30 g per canister). RESULTS: The limits of agreement (LOA) between the device and the reference method for dark (bias: 4.7 g [95% confidence interval {CI}, 3.8-5.6 g]; LOA: -8.1 g [95% CI, -9.7 to -6.6 g] to 17.6 g [95% CI, 16.0-19.1 g]), medium (bias: 3.4 g [95% CI, 2.6-4.1 g]; LOA: -7.4 g [95% CI, -8.7 to -6.1 g] to 14.2 g [95% CI, 12.9-15.5 g]), and bright lighting conditions (bias: 4.1 g [95% CI, 3.2-4.9 g]; LOA: -7.6 g [95% CI, -9.0 to -6.2 g] to 15.7 g [95% CI, 14.3-17.1 g]) fell well within the predetermined clinically significant limits of ±30 g. Repeated measurements of the samples under the various lighting conditions were highly correlated with intraclass correlation coefficient of 0.995 (95% CI, 0.993-0.996; P < .001), showing that lighting conditions did not have a significant impact on measurements. Hb mass bias was significantly associated with hemolysis level (Spearman ρ correlation coefficient, -0.137; P = .001) and total canister volume (Spearman ρ correlation coefficient, 0.135; P = .001), but not ambient illuminance. CONCLUSIONS: The Triton Canister System was able to measure the Hb mass reliably with clinically acceptable accuracy in reconstituted blood samples representing a wide range of Hb concentrations, dilutions, hemolysis, and ambient lighting settings.

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.

Accuracy and trending of non-invasive hemoglobin measurement during different volume and perfusion statuses.

The evolution of non-invasive hemoglobin measuring technology would save time and improve transfusion practice. The validity of pulse co-oximetry hemoglobin (SpHb) measurement in the perioperative setting was previously evaluated; however, the accuracy of SpHb in different volume statuses as well as in different perfusion states was not well investigated. The aim of this work is to evaluate the accuracy and trending of SpHb in comparison to laboratory hemoglobin (Lab-Hb) during acute bleeding and after resuscitation. Seventy patients scheduled for major orthopedic procedures with anticipated major blood loss were included. Radical-7 device was used for continuous assessment of SpHb, volume status [via pleth variability index (PVI)] and perfusion status [via perfusion index (PI)]. Lab-Hb and SpHb were measured at three time-points, a baseline reading, after major bleeding, and after resuscitation. Samples were divided into fluid-responsive and fluid non-responsive samples, and were also divided into high-PI and low-PI samples. Accuracy of SpHb was determined using Bland-Altman analysis. Trending of SpHb was evaluated using polar plot analysis. We obtained 210 time-matched readings. Fluid non-responsive samples were 106 (50.5%) whereas fluid responsive samples were 104 (49.5%). Excellent correlation was reported between Lab-Hb and SpHb (r = 0.938). Excellent accuracy with moderate levels of agreement was also reported between both measures among all samples, fluid non-responsive samples, fluid-responsive samples, high-PI samples, and low-PI samples [Mean bias (limits of agreement): 0.01 (- 1.33 and 1.34) g/dL, - 0.08 (- 1.27 and 1.11) g/dL, 0.09 (- 1.36 and 1.54) g/dL, 0.01 (- 1.34 to 1.31) g/dL, and 0.04 (- 1.31 to 1.39) g/dL respectively]. Polar plot analysis showed good trending ability for SpHb as a follow up monitor. In conclusion, SpHb showed excellent correlation with Lab-Hb in fluid responders, fluid non-responders, low-PI, and high PI states. Despite a favorable mean bias of 0.01 g/dL for SpHb, the relatively wide levels of agreement (- 1.3 to 1.3 g/dL) might limit its accuracy. SpHb showed good performance as a trend monitor.

Comparison of the accuracy of noninvasive hemoglobin monitoring for preoperative evaluation between adult and pediatric patients: a retrospective study.

We measured noninvasive hemoglobin (SpHb) levels during the pre-anesthesia visit in patients planning elective surgery. Differences between SpHb and laboratory-measured hemoglobin (Hblab) were compared between adult and pediatric patients. In the pre-anesthesia visiting office, we routinely monitor noninvasive Hb levels with oxygen saturation and heart rate using Masimo Radical-7® Pulse CO-Oximetry (Masimo Corp., Irvine, CA, USA). We attached the R1 20 (body weight, 10-50 kg) or R1 25 (body weight > 30 kg) probe on the index finger. After signal stabilization, SpHb and perfusion index (PI) were recorded. We retrospectively reviewed the recorded data and included patients who visited the anesthesiologist within 24 h after venous sampling. Bias was calculated by subtracting Hblab from SpHb. We compared the biases of adult and pediatric patients (< 18 years) and evaluated correlation coefficients between the bias and Hblab. Records of 105 patients were reviewed and 100 data points of 50 patients in each group were analyzed. The median ± interquartile range bias was - 2.6 ± 2.2 and - 1.2 ± 1.5 g/dL in adult and pediatric patients, respectively (P < 0.001); the corresponding mean ± standard deviation PIs were 4.4 ± 3.1 and 5.9 ± 2.7, respectively (P = 0.19). Bias was inversely proportional to Hblab irrespective of age. The correlation coefficient between the bias and Hblab was - 0.81 in adults and - 0.54 in pediatric patients (P < 0.001). SpHb and Hblab measured during pre-anesthesia visits showed a smaller difference in pediatric than in adult patients. Lower Hblab corresponded to higher accuracy.

Accuracy of non-invasive continuous total hemoglobin measurement by Pulse CO-Oximetry in severe traumatized and surgical bleeding patients.

The Masimo Radical-7 Pulse CO-Oximeter (Masimo Corp., USA) non-invasively computes hemoglobin concentration (SpHb). SpHb was compared to Co-Oximeter readings (CoOxHb) of arterial samples in surgery patients of the emergency department. Forty-six patients were enrolled. The Masimo R1 25L (revision F and G) adult adhesive sensor was attached to the ring finger of the arterially cannulated hand. Before start, every 30 min during surgery and in the case of severe bleeding SpHb and CoOxHb values were documented. SpHb and post hoc adjusted SpHb (AdSpHb) values were analyzed. Linear regression analysis and Bland-Altman plot for agreement were performed. The detection failure rate of SpHb was 24.5 %. CoOxHb and SpHb showed a strong correlation (r = +0.81), but agreement was moderate [bias (LOA) of -0.6 (-3.0; +1.9)] g/dl. Positive and negative predicted value was 0.49 and 0.69. Exclusion of changes of CoOxHb values ≤1 g/dl resulted in a positive and negative predictive value of 0.66 and 1.00. Post hoc adjustment of the SpHb (AdSpHb) improved linear correlation of CoOxHb and AdSpHb [r = +0.90 (p < 0.001)] but less the agreement [bias (LOA) of CoOxHb and AdSpHb = -0.1 (-2.1/+1.9) g/dl]. SpHb agreed only moderately with CoOxHb values and predicted decreases of CoOxHb only if changes of SpHb ≤ 1.0 g/dl were excluded. The detection failure rate of SpHb was high. At present, additional refinements of the current technology are necessary to further improve performance of non-invasive hemoglobin measurement in the clinical setting.