Noninvasive Hemoglobin Monitoring for Postoperative Pediatric Orthopaedic Patients: A Preliminary Study.

BACKGROUND: Hemoglobin (Hgb) levels are frequently checked through venipuncture [invasive hemoglobin (iHgb)] in pediatric orthopaedic patients after high blood loss procedures. This needlestick may causes further anxiety and fear in hospitalized children. Noninvasive hemoglobin (nHgb) monitoring has been effectively utilized in the adult intensive care and postoperative total joint arthroplasty setting. nHgb monitoring has not yet been validated in children for routine postoperative Hgb assessment in pediatric orthopaedics. METHODS: In this prospective study, 46 pediatric orthopaedic patients were enrolled who were undergoing surgery and postoperative standard of care iHgb testing. On postoperative day 1, Hgb levels were obtained through venipuncture and nHgb monitor (Pronto-7; Masimo) within a 2-hour period. Patient preferences, iHgb and nHgb values, time to result, and provider preferences were recorded. Cost data were estimated based on the standard Medicare payment rates for lab services versus the cost of nHgb probe. RESULTS: nHgb results were obtained after 1 attempt in 38 patients (83%), after multiple attempts in 7 patients (15%), and could not be obtained in 1 patient. The mean time to obtain nHgb value was significantly shorter than that to obtain iHgb results (1.3±1.5 vs. 40±18.1 min; P <0.0001). The mean nHgb value was significantly higher than the mean iHgb value (11.7±1.5 vs. 10.6±1.1 g/dL, P <0.0001). nHgb exceeded iHgb by 2 g/dL or more in 12 (26%) patients (2.64±0.9 vs. 0.54±0.84 g/dL; P <0.0001). The concordance correlation coefficient between the 2 Hgb methods was 0.59, indicating moderate agreement. Forty-three (93%) of our patients and 34 (74%) of the care providers preferred nHgb over iHgb if results were equivalent. At our institution, the cost per iHgb monitoring is approximately $28 per blood draw as compared with $5 for nHgb monitoring. Interestingly, no patients required postoperative transfusion during the study period, as asymptomatic patients with no cardiac disease are typically observed unless the Hgb is <6. CONCLUSIONS: nHgb monitoring in postoperative pediatric patients overestimated Hgb levels compared with the standard of care methods; however, nHgb had high patient and provider satisfaction and had moderate agreement with iHgb. As no patients required transfusion, postoperative Hgb checks could likely be discontinued in some portion of our population. LEVEL OF EVIDENCE: Level Ib-Diagnostic study.

The Use of Atomic Force Microscopy in Comprehensive Assessment of the "Mother-Placenta-Fetus" System in Obstetric and Endocrine Pathology during Pregnancy.

Atomic force microscopy is not very popular in practical health care, therefore, its potential is not studied enough, for example, in obstetrics when studying the "mother-placenta-fetus" system. Our study summarizes the possibilities of using atomic force microscopy for detection of various circulatory disorders and vascular changes at the microscopic level in the uterus (endometrium and myometrium), placenta, and umbilical cord in the main variants of obstetric and endocrine pathology. For instance, in the case of endocrine pathologies, changes in the form of stasis, sludge, diapedesis, ischemia, destruction and separation of endotheliocytes in villous blood vessels were found in the mother. The oxygen content in erythrocytes also naturally decreased in pathologies; poikilo- and anisocytosis were observed.

HCV core antigen plays an important role in the fight against HCV as an alternative to HCV-RNA detection.

OBJECTIVE: To discuss the clinical significance of HCV-cAg testing in the diagnosis, activity determination, and monitoring of therapeutic effectiveness of HCV infection and its advantages compared with HCV-RNA and anti-HCV antibodies detection. METHODS: By summarizing the published literature, the advantages and significance of HCV core antigen detection were sought. RESULTS: The expression of HCV-cAg is highly consistent with that of HCV-RNA, but compared with HCV-RNA, detection of HCV-cAg is easy to operate, time saving, and low cost. HCV-cAg can be detected within 12~15 days after infection, and the window period can be shortened by5~7 weeks. HCV-cAg is a serological indicator of virus replication, which can distinguish previous infection of HCV or current infection. HCV-cAg detection is more suitable for immunocompromised, hemodialysis, organ transplant patients. HCV-cAg also can be used to monitor antiviral efficacy and predict sustained virological response (SVR). CONCLUSION: HCV core antigen has similar clinical sensitivity to NAT and can be used as a substitute for HCV-RNA in the diagnosis of virus infection. Combined detection of HCV-cAg and antibody serology can help doctors detect HCV infection earlier, accurately diagnose different stages of HCV infection, and evaluate the therapeutic effect of antiviral drugs, which are beneficial in the prevention and treatment of hepatitis C.

A comparison of the analysis of 3 types of body fluids using the XN-350 hematology analyzer versus light microscopy assessment.

ABSTRACT: We evaluated the capacity of the XN-350 instrument to analyze 3 different types of body fluid samples under "body fluid mode."The performance of XN-350 was evaluated in terms of precision, carryover, limit of blank, limit of detection, limit of quantification, and linearity. Cell enumeration and differential data produced by the XN-350 were compared to manual chamber counting results in 63 cerebrospinal fluid (CSF), 51 ascitic fluid, and 51 pleural fluid (PF) samples. Comparisons between XN-350 versus Cytospin data were also performed in PF samples.The precision, carry-over, limit of blank, and linearity of the XN-350 were acceptable. The limits of detection for white blood cells (WBCs) and red blood cells were 1.0/µL, and 1,000.0/µL, respectively; the corresponding limits of quantitation (LOQs) were 5.0/µL and 2,000.0/µL, respectively. The XN-350's cell enumeration and differential counting correlated well with those of manual chamber counting for all 3 sample types (except for differential counting in CSF samples), particularly parameters involving monocytes (r = 0.33) and mononuclear cells (MO- body fluid [BF]; r = 0.26), as well as total cell (TC-BF) enumeration (r = 0.50) and WBC-BF (r = 0.50) in PF samples. The MO-BF in CSF samples differed significantly from manual chamber counting results, but neither TC-BF nor WBC-BF in PF samples did. The XN-350 also showed good correlations with Cytospin analyses for differential counting of neutrophils, lymphocytes, and monocytes in PF samples. The differential counting of eosinophils via the XN-350 and Cytospin were not significantly correlated, but the difference between them was not significant.The XN-350 is an acceptable alternative to manual fluid analysis. Samples with low cellularity around the LOQ should be checked manually. Moreover, manual differential counting should be performed on CSF samples, particularity those with low cell numbers.

Magnitude of Anemia and Associated Factors Among Human Immunodeficiency Virus Infected Children on Highly Active Antiretroviral Therapy at University of Gondar Comprehensive and Specialized Referral Hospital Northwest Ethiopia.

BACKGROUND: Anemia is one of the most common hematological problems in HIV infected patients in the world. The main aim of this study was to determine the magnitude of anemia and associated factors among HIV infected children on highly active antiretroviral therapy attending University of Gondar Comprehensive and Specialized Referral Hospital. METHODS: A retrospective study was conducted from 2013 to 2018 by reviewing medical records at University of Gondar Comprehensive and Specialized Referral Hospital ART clinic. Records of 238 HIV infected children on HAART were selected using a convenient sampling technique. Socio-demographic characteristics, clinical information, and hematological and immunological profiles of the study participants were collected from the patients record books. WHO cutoff value of hemoglobin was taken and adjusted to define anemia in higher altitude. Data was analyzed by using the SPSS version 20 statistical software, and odds ratios with 95% confidence intervals were used to quantify the strength of association between anemia and its potential predictors. RESULTS: The overall prevalence of anemia among HIV infected children in this study was 38.7%. Of anemic children, 48.9% had mild, 39.1% moderate, and 11.9% severe anemia. This study showed that HIV infected children on Highly Active Antiretroviral Therapy who live in rural residence had a two-fold risk of being anemia than urban dwellers (AOR = 2.151, 95% CI, 1.123 - 4.122). There was no significant association with gender, WHO clinical stage, opportunistic infections, cotrimoxazole treatment, and CD4 count percentage. CONCLUSIONS: Anemia is a common problem among the children taking highly active antiretroviral therapy. Therefore, health care workers need to routinely investigate and treat anemia, especially in rural dwellers. Furthermore, large scale and longitudinal studies are recommended to strengthen and explore the problem in depth.

Are Routine Laboratory Investigations Necessary Following Percutaneous Nephrolithotomy?

OBJECTIVE: To determine how effective routine postoperative blood work is in identifying complications after percutaneous nephrolithotomy (PCNL), the gold standard treatment for large volume stone disease. Although major complication rates are low, hemorrhagic and sepsis-related complications are serious and can occur. Routine post-PCNL complete blood count is routinely performed by most endourologists but may be a low-value practice. METHODS: A retrospective review was performed of all PCNL procedures at our center over a 3-year period. Patient demographic, stone characteristics and postoperative data were collected and analyzed. RESULTS: Three hundred and eighty-five patients (196 female and 189 males) underwent PCNL for the treatment of urolithiasis. Mean age was 55.8 years and mean length of stay in hospital was 1.74 days. Most patients (82.9%) had neither ureteric stent nor percutaneous tube prior to PCNL. Postoperatively, 4 patients (1.0%) required a blood transfusion and 14 patients (3.6%) developed urosepsis. Patients who required either a transfusion or developed urosepsis demonstrated abnormal vital signs (tachycardia, hypotension, or fever) postoperatively. Sixteen patients (4.2%) had normal vital signs but had an extended hospital stay only to monitor abnormal blood work results. None these patients required a transfusion nor developed urosepsis but had a length of stay that was a mean of 1.5 days longer patients with normal postoperative vital signs and blood work. CONCLUSION: Abnormal vital signs alone identified all patients that required transfusion or treatment for urosepsis after PCNL. Routine complete blood count testing postoperatively may not improve detection of infectious or bleeding complications and may prolong hospital admission unnecessarily.

A validated composite organ and hematologic response model for early assessment of treatment outcomes in light chain amyloidosis.

Newly diagnosed AL amyloidosis patients were evaluated to develop a model for early assessment of treatment benefit at 6 months, integrating both hematologic (HR) and organ response (OR) assessment (testing cohort, Mayo: n = 473; validation cohort, Pavia: n = 575). Multiple OR were assessed as follows: All OR (AOR): response in all organs, mixed OR (MOR): response in some organs, no OR (NOR)]. AOR rates at 6 months improved with deepening HR; complete response (CR; 38%, 35%), very good partial response (VGPR; 30%, 26%), and partial response (PR; 16%, 21%), respectively. A composite HR/OR (CHOR) model was developed using incremental scoring based on hazard ratios with scores of 0-3 for HR (0-CR, 1-VGPR, 2-PR, 3-no response) and 0-2 for OR (0-AOR, 1-MOR, 2-NOR). Patients could be divided into two distinct CHOR groups (scores 0-3 and 4-5), with median OS in group 1 and group 2: Not reached vs. 34 months, p < 0.001 [Mayo] and 87 vs. 23 months, p < 0.001 [Pavia]. In conclusion, we developed a model that can assess multiple organs concurrently, and integrate both HR and OR assessments to determine early clinical benefit with treatment, which may be used as a surrogate end-point in trials and to compare outcomes with different therapies.

ATBdiscrimination: An in Silico Tool for Identification of Active Tuberculosis Disease Based on Routine Blood Test and T-SPOT.TB Detection Results.

Tuberculosis remains one of the deadliest infectious diseases worldwide. Only 5-15% of people infected with Mycobacterium tuberculosis develop active TB disease (ATB), while others remain latently infected (LTBI) during their lifetime, which has a completely different clinical treatment schedule. However, most current clinical diagnostic methods are based on the immune response of M. tuberculosis infections and cannot distinguish ATB from LTBIs. Thus, the rapid diagnosis of active or latent tuberculosis infections remains a serious challenge for clinicians. In this work, based on the test data of a total of 478 patients, 36 blood biochemical data were specially included with T-SPOT.TB detection results which are all from routine clinical practice as commercially available. Then a discrimination method to detect ATB infections was successfully developed based on these data by the random forest algorithm. This method presents a robust classification performance with AUC as 0.9256 and 0.8731 for the cross-validation set and the external validation set, respectively. This work suggests an innovative strategy for identification of ATB disease from a single drop of blood with advantages of being timely, efficient, and economical. It also provides valuable information for the comprehensive understanding of TB with deep associations between TB infection and routine blood test data. The web server of this identification method, called ATBdiscrimination, is now available online at http://lishuyan.lzu.edu.cn/ATB/ATBdiscrimination.html .

The Utility and Cost Effectiveness of Immediate Postoperative Laboratory Studies in Hip and Knee Arthroplasty.

BACKGROUND: Routine immediate postoperative laboratory studies, including metabolic panels and hematologic profiles, are commonly ordered after arthroplasty procedures. However, their values only occasionally influence management. This study investigated the clinical utility and value of these tests. METHODS: A large retrospective cohort study of 18,935 patients spanning a 6-year period from 2008 to 2013 from a single high-volume institution was evaluated. Only immediate postoperative labs drawn on postoperative day 0 in the recovery room were included in the study. Complete blood counts (CBC) and basic metabolic panels (BMP) were reviewed, and ranges of abnormal were set for each lab test based on values significant enough to impact patient management. Cost effectiveness calculations were made based on current cost of the laboratory tests. RESULTS: Actionably low hemoglobin values ( < 8 g/dL) were found in 1.44% of the overall cohort. Unilateral primary total knee arthroplasty was associated with the fewest hemoglobin abnormalities at 0.59%. Primary unilateral total hip arthroplasty was associated with abnormal hemoglobin values in 1.81% of cases. Significant electrolyte abnormalities were far less common, with hyperkalemia (> 6.5 mEq/L) in 0.19%, hyponatremia ( < 120 mEq/L) in 0.01% and elevated creatinine (> 2.0 mg/dL) was found in 0.25%. Hemoglobin values were calculated at a cost of $1,710 to detect a single significantly abnormal result. The cost to detect a single actionably abnormal BMP value was $1,000. CONCLUSIONS: Routine immediate postoperative laboratory tests represent a high institutional cost and are seldom abnormal enough to warrant a change in patient management. The routine use of these tests can likely be safely eliminated in uncomplicated primary unilateral arthroplasty procedures.

HemoTypeSC, a low-cost point-of-care testing device for sickle cell disease: Promises and challenges.

BACKGROUND: Sickle cell disease (SCD) is a neglected burden of growing importance. >312,000 births are affected annually by sickle cell anaemia (SCA). Early interventions such as newborn screening, penicillin prophylaxis and hydroxyurea can substantially reduce the mortality and morbidity associated with SCD. Nevertheless, their implementation in African countries has been mostly limited to pilot projects. Recent development of low-cost point-of-care testing (POCT) devices for sickle haemoglobin (HbS) could greatly facilitate the diagnosis of those affected. METHODS: We conducted the first multi-centre, real-world assessment of a low-cost POCT device, HemoTypeSC, in a low-income country. Between September and November 2017, we screened 1121 babies using both HemoTypeSC and HPLC and confirmed discordant samples by molecular diagnosis. FINDINGS: We found that, in optimal field conditions, the sensitivity and specificity of the test for SCA were 93.4% and 99.9%, respectively. All 14 carriers of haemoglobin C were successfully identified. Our study reveals an overall accuracy of 99.1%, but also highlights the importance of rigorous data collection, staff training and accurate confirmatory testing. It suggests that HPLC results might not be as reliable in a resource-poor setting as usually considered. INTERPRETATION: The use of such a POCT device can be scaled up and routinely used across multiple healthcare centres in sub-Saharan Africa, which would offer great potential for the identification and management of vast numbers of individuals affected by SCD who are currently undiagnosed. FUNDING US: Imperial College London's Wellcome Trust Centre for Global Health Research (grant #WMNP P43370).

[Analysis and management of the pre-analytical risks in hemostasis]. / Analyse et gestion des risques de la phase pré-analytique en hémostase.

Risk analysis consists in identification, scoring and ranking of risks in order to manage the major risks. The aim of the study is to determine the risk analysis of the pre-analytical step of routine hemostasis in Hematological laboratory of CHU Ibn Rochd-Casablanca, Morocco. MATERIAL AND METHODS: The identification of pre-analytical activities of routine hemostasis was extensively realized according to a "by-proccess" methodology. According to "5M" analysis, we identified the risks associated with these activities. Therefore, the scoring of each risk was realized according to «AMDEC¼ methodology, by the staff of hematological laboratory. Risks were classified according to their severity and the major were identified using "Pareto diagram". RESULTS: Forty eight risks were identified in 15 activities. Identity monitoring (13.7%), pre-analytical storage of samples (13.4%), pre-analytical treatment, including centrifugation (12.9%) and transport to the laboratory (11.3%) represented the activities that exhibited the highest level of risk. Using "Pareto diagram", we retained 19 major risks, related to medical prescription, identity monitoring, transport to the laboratory, pre-analytical treatment of samples and IT processing. DISCUSSION AND CONCLUSION: Risk analysis allowed the identification of 19 major risks out of 48 identified risks, related to the pre-analytical step of routine hemostasis. These 19 major risks needed a plan to reduce their criticity.

Claros System: A Rapid Microfluidics-Based Point-of-Care System for Quantitative Prostate Specific Antigen Analysis from Finger-Stick Blood.

INTRODUCTION: Determination of circulating prostate specific antigen (PSA) is commonly used in the diagnosis and treatment monitoring of prostate cancer [1]. Presently, PSA testing is performed in centralized laboratories, which is associated with prolonged time between venipuncture and the PSA value being available. In this prospective study, we present a new and rapid test system for the quantitative determination of PSA levels from finger-stick blood. METHODS: The Claros1® analyzer is a rapid microfluidics-based point-of-care system for quantitative PSA analysis from 10-µl finger-stick blood that requires only 10 min for testing. Total PSA concentrations by the Claros system in 100 consecutive asymptomatic men (median age 57 years, range 44-81 years) were compared with two commercially available, commonly used PSA assays (Abbott and Elecsys by Roche) performed by a reference laboratory. RESULTS: Eighty-six percent of finger-stick blood-borne probes from 100 men were evaluable for PSA testing by the Claros1® analyzer system. In 13/14 cases the expiry date of the microfluid cassettes of the Claros system was exceeded and one blood puncture was performed inadequately. The correlations between the Claros results and OPKO-Abbott and OPKO-Roche assay results were high, with R2 values of 0.982 and 0.985, respectively. The R2 value for the Roche-Abbott correlation was 0.991 with a slope value of 1.160. Prostate cancer was diagnosed in seven cases, with a median PSA of 1.8 ng/ml in the Claros group compared to 1.75 ng/ml and 2.1 ng/ml in the Abbott and Roche groups, respectively. CONCLUSION: The Claros1® PSA assay combines the advantages of rapid, accurate detection with a low required sample volume, allowing the analysis to be performed using finger-stick blood. Provided that further analysis proves the reproducibility of the test, it may help to reduce the number of office visits, thus decreasing costs to the health care system.

Utility of cell population data (VCS parameters) as a rapid screening tool for Acute Myeloid Leukemia (AML) in resource-constrained laboratories.

INTRODUCTION: Despite advances in diagnostic techniques, many cases of acute myeloid leukemia (AML) remain underdiagnosed in remote centers unequipped with these technologies. We hypothesized that the automated cellular indices with scatter plots and flags may aid in rapid and cost-effective screening of AML. METHODS: Cell population data (CPD) parameters from 100 de novo AML samples were analyzed by Coulter LH 780 automated analyzer and were compared with 100 age-matched controls. Similar parameters were also compared with 100 and 50 reactive cases of neutrophilia and monocytosis, respectively. System-generated flags and scatter plot patterns were also analyzed. RESULTS: Results were compared between AML cases and normal controls; AML FAB M2, M3, M4 vs reactive neutrophilia; AML FAB M4, M5 vs reactive monocytosis. Significant parameters were selected from all comparison groups. Using appropriate statistical tools, we calculated the cutoff values of these parameters and were able to screen out AML cases with 94% sensitivity and 95% specificity. Three statistical equations were generated using two of the most significant parameters which improved the sensitivity to 98% and specificity to 99%. Five hypothetical scatter plot patterns were devised and were classified according to FAB categories of AML. Most common pattern was selected in AML which was seen in 56% of the cases. Output was analyzed combining these patterns and flags with CPD parameters. CONCLUSION: CPD either alone or in the form of statistical equations along with scatter plots and flags can provide rapid and economic tool in preliminary diagnosis of AML in cost-constrained settings.

Faecal immunochemical tests for haemoglobin (FIT) in the assessment of patients with lower abdominal symptoms: current controversies.

Faecal immunochemical tests for haemoglobin (FIT), as an adjunct to clinical information, assist in the triage of patients presenting in primary care with lower abdominal symptoms. Controversy remains regarding whether and which qualitative and quantitative FIT can be used, which groups of patients would benefit most from FIT, whether FIT should be done in primary and/or secondary care, and how FIT should be incorporated into diagnostic pathways. Controversy also exists as to the optimum cut-off used for referral for colonoscopy. A single sample of faeces may be sufficient. Reporting of results requires consideration. FIT provide a good rule in test for colorectal cancer and a good rule out test for significant bowel disease, but robust safety-netting is required for patients with negative results and ongoing symptoms. Risk scoring models have been developed, but their value is unclear as yet. Further evaluation of these topics is required to inform good practice.

The impact of status and social context on health service co-design: an example from a collaborative improvement initiative in UK primary care.

BACKGROUND: Increasingly, collaborative participatory methods requiring open and honest interaction between a range of stakeholders are being used to improve health service delivery. To be successful these methodologies must incorporate perspectives from a range of patients and staff. Yet, if unaccounted for, the complex relationships amongst staff groups and between patients and providers can affect the veracity and applicability of co-designed solutions. METHODS: Two focus groups convened to discuss suggestions for the improvement of blood testing and result communication in primary care. The groups were mixed of patients and staff in various combinations drawn from the four participating study practices. Here we present a secondary mixed-method analysis of the interaction between participants in both groups using sociogrammatic and thematic analysis. RESULTS: Despite a similar mix of practice staff and patients the two groups produced contrasting discussions, seemingly influenced by status and social context. The sociograms provided a useful insight into the flow of conversation and highlighted the dominance of the senior staff member in the first focus group. Within the three key themes of social context, the alliances formed between participants and the fluidity of the roles assumed manifested differently between groups apparently dictated by the different profile of the participants of each. CONCLUSIONS: For primary care service improvement attention must be paid to the background of participants when convening collaborative service improvement groups as status and imported hierarchies can have significant connotations for the data produced.