scholarly journals Head to head comparisons in performance of CD4 point–of-care assays: A Bayesian meta-analysis (2000-2013)

2014 ◽  
Author(s):  
Samantha Wilkinson ◽  
Tiago Chiavegatti ◽  
Benedicte Nauche ◽  
Given Names Deactivated Family Name Deactivated ◽  
Nitika Pant Pai
Keyword(s):  
Flow Cytometry ◽  
Point Of Care ◽  
Meta Analysis ◽  
Venous Blood ◽  
Capillary Blood ◽  
Sufficient Data ◽  
Bayesian Hierarchical ◽  
Cell Counts ◽  
Meta Analyses ◽  
Cd4 Cell

Background: Timely detection, staging, treatment initiation are pertinent to controlling HIV Infection. CD4+ cell-based point-of-care (POC) devices offer the potential to rapidly stage patients, and decide on initiating treatment, but a comparative evaluation of their performance has not yet been performed. With this in mind, we conducted a systematic review and meta-analyses. Methods: For the period Jan 2000 to April 2015, 19 databases were systematically searched, 6619 citations retrieved, and 25 articles selected. Diagnostic performance was compared across devices (i.e., PIMA, CyFlow, miniPOC, MBioCD4 System) and across specimens (i.e., capillary blood vs. venous blood). A Bayesian approach was used to meta-analyze the data. The primary outcome, the Bland-Altman (BA) mean bias (which represents agreement between cell counts from POC device and flow cytometry), was analyzed with a Bayesian hierarchical normal model. Findings: We performed a head-to-head comparison of two point-of-care devices, PIMA and PointCareNOW CD4. PIMA appears to perform better vs. PointCareNOW with venous samples (BA mean bias: -9.5 cells/μL; 95% CrI:-37.71 to 18.27 vs. 139.3 cells/μL; 95% CrI:-0.85 to 267.4, mean difference = 148.8, 95% CrI: 11.8, 285.8); however, PIMA’s best performed when used with capillary samples (BA mean bias: 2.2 cells/μL; 95% CrI:-19.32 to 23.6). Sufficient data was available to allow pooling of sensitivity and specificity data only at the 350 cells/μL cutoff. For PIMA device sensitivity 91.6 (84.7 to 95.5) and specificity was 94.8 (90.1 to 97.3) respectively. There was not sufficient data to allow comparisons between any other devices. Conclusions: PIMA device was comparable to flow cytometry. The estimated differences between the CD4+ cell counts of the device and the reference was small and best estimated in capillary blood specimens. As the evidence stands, the PointCareNOW device will need to improve prior to widespread use and more data on MBio and MiniPOC are needed. Findings inform implementation of PIMA and improvements in other CD4 POC device prior to recommending widespread use.

scholarly journals Head to head comparisons in performance of CD4 point-of-care assays: a Bayesian meta-analysis (2000–2013)

2015 ◽  
Author(s):  
Samantha Wilkinson ◽  
Tiago Chiavegatti ◽  
Benedicte Nauche ◽  
Given Names Deactivated Family Name Deactivated ◽  
Nitika Pant Pai
Keyword(s):  
Flow Cytometry ◽  
Point Of Care ◽  
Meta Analysis ◽  
Venous Blood ◽  
Capillary Blood ◽  
Sufficient Data ◽  
Bayesian Hierarchical ◽  
Cell Counts ◽  
Meta Analyses ◽  
Cd4 Cell

Abstract Timely detection, staging, and treatment initiation are pertinent to controlling HIV infection. CD4+ cell-based point-of-care (POC) devices offer the potential to rapidly stage patients, and decide on initiating treatment, but a comparative evaluation of their performance has not yet been performed. With this in mind, we conducted a systematic review and meta-analyses. For the period January 2000 to April 2014, 19 databases were systematically searched, 6619 citations retrieved, and 25 articles selected. Diagnostic performance was compared across devices (i.e., PIMA, CyFlow, miniPOC, MBioCD4 System) and across specimens (i.e., capillary blood vs. venous blood). A Bayesian approach was used to meta-analyze the data. The primary outcome, the Bland–Altman (BA) mean bias (which represents agreement between cell counts from POC device and flow cytometry), was analyzed with a Bayesian hierarchical normal model. We performed a head-to-head comparison of two POC devices including the PIMA and PointCareNOW CD4. PIMA appears to perform better vs. PointCareNOW with venous samples (BA mean bias: –9.5 cells/μL; 95% CrI: –37.71 to 18.27, vs. 139.3 cells/μL; 95% CrI: –0.85 to 267.4, mean difference = 148.8, 95% CrI: 11.8, 285.8); importantly, PIMA performed well when used with capillary samples (BA mean bias: 2.2 cells/μL; 95% CrI: –19.32 to 23.6). Sufficient data were available to allow pooling of sensitivity and specificity data only at the 350 cells/μL cutoff. For PIMA device sensitivity 91.6 (84.7–95.5) and specificity was 94.8 (90.1–97.3), respectively. There were not sufficient data to allow comparisons between any other devices. PIMA device was comparable to flow cytometry. The estimated differences between the CD4+ cell counts of the device and the reference was small and best estimated in capillary blood specimens. As the evidence stands, the PointCareNOW device will need to improve prior to widespread use and more data on MBio and MiniPOC are needed. Findings inform implementation of PIMA and improvements in other CD4 POC device prior to recommending widespread use.

scholarly journals Capillary blood tests may overestimate ketosis: triangulation between three different measures of β-hydroxybutyrate

2020 ◽  
Vol 318 (2) ◽  
pp. E184-E188 ◽  
Author(s):  
Jakob Norgren ◽  
Shireen Sindi ◽  
Anna Sandebring-Matton ◽  
Ingemar Kåreholt ◽  
Ulrika Akenine ◽  
...  
Keyword(s):  
Regression Models ◽  
Ketone Body ◽  
Point Of Care ◽  
Venous Blood ◽  
Capillary Blood ◽  
Dietary Interventions ◽  
Healthy Older Adults ◽  
Time Points ◽  
Blood Tests ◽  
Good Agreement

The ketone body β-hydroxybutyrate (BHB), assessed by a point-of-care meter in venous whole blood (BHBv), was used as the main outcome in a study on nutritional ketosis in healthy older adults. Two other BHB measures were also used in the study for validation and exploratory purposes, and here we report findings on correlation and agreement between those three methods. Ketosis in the range of 0–1.5 mmol/L was induced in 15 healthy volunteers by intake of medium-chain fatty acids after a 12-h fast. BHBv was assessed at 12 time points for 4 h. The same point-of-care meter was also used to test capillary blood (BHBc) at three time points, and a laboratory test determined total ketones (TK) in plasma (BHBp + acetoacetate) at four time points. A total of 180 cases included simultaneous data on BHBv, BHBc, BHBp, and TK. TK correlated with BHBp (Pearson’s r = 0.99), BHBv ( r = 0.91), and BHBc ( r = 0.91), all P < 0.0001. BHBv and BHBp had good agreement in absolute values. However, the slope between BHBc and BHBv, measured with the same device, was in the range of 0.64–0.78 in different regression models, indicating substantially higher BHB concentrations in capillary versus venous blood. We conclude that all three methods are valid to detect relative changes in ketosis, but our results highlight the importance of method considerations and the possible need to adjust cutoffs, e.g., in the management of ketoacidosis and in the evaluation and comparison of dietary interventions.

scholarly journals Surgical management of focal chondral defects of the knee: a Bayesian network meta-analysis

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Filippo Migliorini ◽  
Jörg Eschweiler ◽  
Hanno Schenker ◽  
Alice Baroncini ◽  
Markus Tingart ◽  
...  
Keyword(s):  
Bayesian Network ◽  
Meta Analysis ◽  
Surgical Techniques ◽  
Continuous Variables ◽  
Surgical Interventions ◽  
Bayesian Hierarchical ◽  
Chondral Defects ◽  
Chondrocyte Implantation ◽  
Meta Analyses

Abstract Background Focal chondral defects of the knee are common. Several surgical techniques have been proposed for the management of chondral defects: microfractures (MFX), osteochondral autograft transplantation (OAT), autologous matrix-induced chondrogenesis (AMIC) and autologous chondrocyte implantation (ACI)—first generation (pACI), second generation (cACI) and third generation (mACI). A Bayesian network meta-analysis was conducted to compare these surgical strategies for chondral defects in knee at midterm follow-up. Methods This Bayesian network meta-analysis was conducted according to the PRISMA extension statement for reporting of systematic reviews incorporating network meta-analyses of health care interventions. PubMed, Google Scholar, Embase and Scopus databases were accessed in July 2021. All the prospective comparative clinical trials investigating two or more surgical interventions for chondral defects of the knee were accessed. The network meta-analyses were performed through a Bayesian hierarchical random-effects model analysis. The log odds ratio (LOR) effect measures were used for dichotomic variables, while the standardized mean difference (SMD) for the continuous variables. Results Data from 2220 procedures (36 articles) were retrieved. The median follow-up was 36 (24 to 60) months. The ANOVA test found good baseline comparability between symptoms duration, age, sex and body mass index. AMIC resulted in higher Lysholm score (SMD 3.97) and Tegner score (SMD 2.10). AMIC demonstrated the lowest rate of failures (LOR −0.22) and the lowest rate of revisions (LOR 0.89). As expected, MFX reported the lower rate of hypertrophy (LOR −0.17) followed by AMIC (LOR 0.21). No statistically significant inconsistency was found in the comparisons. Conclusion AMIC procedure for focal chondral defects of the knee performed better overall at approximately 3 years’ follow-up.

scholarly journals Impact of tourniquet during knee arthroplasty: a bayesian network meta-analysis of peri-operative outcomes

2021 ◽  
Author(s):  
Filippo Migliorini ◽  
Nicola Maffulli ◽  
Paolo Aretini ◽  
Andromahi Trivellas ◽  
Markus Tingart ◽  
...  
Keyword(s):  
Bayesian Network ◽  
Knee Arthroplasty ◽  
Meta Analysis ◽  
Full Time ◽  
Bayesian Hierarchical ◽  
Operative Outcomes ◽  
Duration Of Surgery ◽  
Meta Analyses ◽  
No Tourniquet

Abstract Introduction The role of tourniquet during knee arthroplasty is controversial. The present study compares various tourniquet protocols using a Bayesian network meta-analysis of peri-operative data. Material and methods The present study was conducted in accordance with the PRISMA extension statement for reporting systematic reviews incorporating network meta-analyses of health interventions. The literature search was conducted in September 2020. All clinical trials investigating the role of tourniquet in knee arthroplasty were considered for inclusion. Methodological quality was assessed using Review Manager 5.3. A Bayesian hierarchical random-effects model analysis was used in all comparisons. Results Ultimately, pooled data from 68 studies (7413 procedures) were analysed. Significant inconsistency was found in the data relating to total estimated blood lost; no assumption could be made on this outcome. Full-time tourniquet resulted in the shortest surgical duration and lowest intra-operative blood lost, in both cases followed by incision-to-suture. The incision-to-suture protocol achieved the smallest drop in haemoglobin during the first 72 h post-operatively and the lowest rate of blood transfusion, both followed by full-time tourniquet. Hospitalisation was shortest in the absence (no-tourniquet) group, followed by the cementation-to-end group. Conclusion For knee arthroplasty, longer tourniquet use is associated with the shorter duration of surgery, lower intra-operative blood lost, lower drops in haemoglobin and fewer transfusion units. The shortest average hospitalisation was associated with no tourniquet use.

Point-of-care measurement of clozapine concentration using a finger-stick blood sample

2021 ◽  
pp. 026988112199156
Author(s):  
David Taylor ◽  
Matthew Atkins ◽  
Robert Harland ◽  
Irina Baburina ◽  
James H MacCabe ◽  
...  
Keyword(s):  
Blood Sample ◽  
Point Of Care ◽  
Venous Blood ◽  
Laboratory Method ◽  
Capillary Blood ◽  
Strong Positive Correlation ◽  
Blood Samples ◽  
Clozapine Concentration ◽  
Capillary Sample ◽  
Finger Stick

Background: The use of clozapine demands regular monitoring of clozapine plasma concentrations and of white blood cell parameters. The delay between sending blood samples for analysis and receiving the results hinders clinical care. Point-of-care testing (POCT) can provide drug assay results within a few minutes. Aim: This study aimed to investigate the utility of a novel point-of-care device that can measure clozapine concentrations using capillary blood samples collected via a finger stick. Method: During a five-week period starting in June 2019 eligible patients were asked to provide a finger-stick capillary sample in addition to their usual venous blood sample. Samples were analysed by the novel point-of-care device and by the standard laboratory method. Capillary blood samples were tested by the MyCare™ Insite POCT analyser, and a quantitative measurement of clozapine concentration was provided within six minutes. Results: A total of 309 patients agreed to measurements by the two methods. Analysis revealed clozapine concentrations in venous blood as determined by the laboratory method ranged from 20 to 1310 ng/mL and by POCT from 7 to 1425 ng/mL. There was a strong positive correlation ( R = 0.89) between the results from the venous and the capillary sample methods. The slope of the association between standard assay and MyCare™ Insite was 1.0 with an intercept of –21 ng/mL, indicating minimal bias. Conclusion: Clozapine concentrations can be accurately measured at the point of care using capillary blood samples collected via a finger stick. This approach may be more acceptable than venous sampling to patients and, with almost instant results available, more useful to clinicians.

scholarly journals Effects of Probiotics on Diarrhea and CD4 Cell Count in People Living With HIV: A Systematic Review and Meta-Analysis

2021 ◽  
Vol 12 ◽  
Author(s):  
Xiao-Li Zhang ◽  
Ming-Hui Chen ◽  
Shi-Tao Geng ◽  
Juehua Yu ◽  
Yi-Qun Kuang ◽  
...  
Keyword(s):  
Fixed Effects ◽  
Meta Analysis ◽  
People Living With Hiv ◽  
Preventive Strategy ◽  
Fixed Effects Model ◽  
Aids Patients ◽  
Cd4 Cell Count ◽  
Cell Counts ◽  
Cd4 Cell ◽  
Hiv Aids

Gastrointestinal probiotics play an important role in maintaining intestinal bacteria homeostasis. They might benefit people with human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS), which remains a global health challenge. However, there is a controversy regarding the efficacy of probiotics for the treatment of AIDS. This study systematically reviewed the evidence of the effects of existing probiotic interventions on AIDS and sought to provide information on the role of probiotics in the treatment of HIV/AIDS patients. A meta-analysis of studies identified by screening multiple databases was performed using a fixed-effects model in Review Manager 5.2 software. The meta-analysis showed that probiotics could reduce the incidence of AIDS-related diarrhea (RR = 0.60 (95% CI: 0.44–0.82), p = 0.001). The short-term use of probiotics (supplementation duration shorter than 30 days) did not reduce the incidence of diarrhea (RR = 0.76 (95% CI: 0.51–1.14), p = 0.19), while the long-term use of probiotics (supplementation duration longer than 30 days) reduced diarrhea (RR = 0.47 (95% CI: 0.29–0.76), p = 0.002). Probiotics had no effect on CD4 cell counts in HIV/AIDS patients (MD = 21.24 (95% CI: −12.95–55.39), p = 0.22). Our data support that probiotics were associated with an obvious reduction in AIDS-related diarrhea, which indicates the need for additional research on this potential preventive strategy for AIDS.

Point-of-care haemoglobin measurement in pooled capillary blood by a portable autoanalyser: comparison with venous blood haemoglobin measured by reference methods in cross-sectional and longitudinal studies

2021 ◽  
pp. 1-27
Author(s):  
Teena Dasi ◽  
Ravindranadh Palika ◽  
Raghu Pullakhandham ◽  
Little Flower Augustine ◽  
Naveen K. Boiroju ◽  
...  
Keyword(s):  
Longitudinal Study ◽  
Point Of Care ◽  
Venous Blood ◽  
Cross Sectional Study ◽  
Capillary Blood ◽  
Sectional Study ◽  
Limits Of Agreement ◽  
Cross Sectional ◽  
Reference Methods ◽  
Hb C

Abstract Population-based surveys commonly use point-of-care (POC) methods with capillary blood samples for estimating haemoglobin (Hb) concentrations; these estimates need to be validated by comparison with reference methods using venous blood. In a cross-sectional study in 748 participants (17-86y, 708 women, Hb: 5.1 to 18.2 g/dL) from Hyderabad, India, we validated Hb measured from a pooled capillary blood sample by a POC autoanalyser (Horiba ABX Micros 60OT, Hb-C-AA) by comparison with venous blood Hb measured by two reference methods: POC autoanalyser (Hb-V-AA) and cyanmethemoglobin method (Hb-V-CM). These comparisons also allowed estimation of blood sample related and equipment related differences in the Hb estimates. We also conducted a longitudinal study in 426 participants (17-21y) to measure differences in the Hb response to iron folate treatment by the capillary blood POC method compared to the reference methods. In the cross-sectional study, Bland Altman analyses showed trivial differences between source of blood (Hb-C-AA and Hb-V-AA; mean difference, limits of agreement: 0.1, -0.8 to 1.0 g/dL) and between analytical methods (Hb-V-AA and Hb-V-CM; mean difference, limits of agreement :< 0.1, −1.8 to 1.8 g/dL). Cross-sectional anaemia prevalence estimated using Hb-C-AA did not differ significantly from Hb-V-CM or Hb-V-AA. In the longitudinal study, the Hb increment in response to IFA intervention was not different when using Hb-C-AA (1.6 ± 1.7 g/dL) compared to Hb-V-AA (1.7± 1.7g/dL) and Hb-V-CM (1.7± 1.7 g/dL). The pooled capillary blood–autoanalyzer method (Hb-C-AA) offers a practical and accurate way forward for POC screening of anaemia.

scholarly journals Performance characteristics of an instrument-free point-of-care CD4 test (VISITECT®CD4) for use in resource-limited settings

2020 ◽  
Vol 48 (9) ◽  
pp. 030006052095502
Author(s):  
Vairamohan Vidhyavathi ◽  
Hussain Syed Iqbal ◽  
Kannaiyan Kanthamani ◽  
Sunil Suhas Solomon ◽  
Paneerselvam Nandagopal ◽  
...  
Keyword(s):  
Flow Cytometry ◽  
Predictive Value ◽  
Point Of Care ◽  
Low Cost ◽  
Venous Blood ◽  
Hiv Positive ◽  
Resource Limited ◽  
Immunodeficiency Virus ◽  
Finger Prick ◽  
Sensitivity Specificity

Objective CD4+ T lymphocyte count remains the most common biomarker of immune status and disease progression in human immunodeficiency virus (HIV)-positive individuals. VISITECT®CD4 is an instrument-free, low-cost point-of-care CD4 test with a cut-off of 350 CD4 cells/μL. This study aimed to evaluate VISITECT®CD4 test's diagnostic accuracy. Methods Two hundred HIV-positive patients attending a tertiary HIV centre in South India were recruited. Patients provided venous blood for reference and VISITECT®CD4 tests. An additional finger-prick blood sample was obtained for VISITECT®CD4. VISITECT®CD4's diagnostic performance in identifying individuals with CD4 counts ≤350 cells/μL was assessed by calculating sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) taking flow cytometry as the reference. Results The overall agreement between VISITECT®CD4 and flow cytometry was 89.5% using venous blood and 81.5% using finger-prick blood. VISITECT®CD4 showed better performance using venous blood [sensitivity: 96.6% (95% confidence interval: 92.1%–98.9%), specificity: 70.9% (57.1%–82.4%), PPV: 89.7% (83.9%–94.0%) and NPV: 88.6% (75.4%–96.2%)] than using finger-prick blood [sensitivity: 84.8% (77.9%–90.2%), specificity: 72.7% (59.0%–83.9%), PPV: 89.1% (82.7%–93.8%) and NPV: 64.5% (51.3%–76.3%)]. Conclusion VISITECT®CD4 performed well using venous blood, demonstrating its potential utility in decentralization of CD4 testing services in resource-constrained settings.

A Comparison of Venous versus Capillary Blood Samples when Measuring Blood Glucose Using a Point-of-Care, Capillary-Based Glucometer

2019 ◽  
Vol 34 (05) ◽  
pp. 506-509
Author(s):  
Jessica Topping ◽  
Matthew Reardon ◽  
Jake Coleman ◽  
Brian Hunter ◽  
Haruka Shojima-Perera ◽  
...  
Keyword(s):  
Blood Glucose ◽  
Point Of Care ◽  
Research Question ◽  
Venous Blood ◽  
Hospital Setting ◽  
Capillary Blood ◽  
Needle Stick Injury ◽  
Blood Samples ◽  
Significant Difference ◽  
Venous Sample

AbstractBackground:Blood glucose level (BGL) is routinely assessed by paramedics in the out-of-hospital setting. Most commonly, BGL is measured using a blood sample of capillary origin analyzed by a hand-held, point-of-care glucometer. In some clinical circumstances, the capillary sample may be replaced by blood of venous origin. Given most point-of-care glucometers are engineered to analyze capillary blood samples, the use of venous blood instead of capillary may lead to inaccurate or misleading measurements.Hypothesis/Problem:The aim of this prospective study was to compare mean difference in BGL between venous and capillary blood from healthy volunteers when measured using a capillary-based, hand-held, point-of-care glucometer.Methods:Using a prospective observational comparison design, 36 healthy participants provided paired samples of blood, one venous and the other capillary, taken near simultaneously. The BGL values were similar between the two groups. The capillary group had a range of 4.3mmol/l, with the lowest value being 4.4mmol/l and 8.7mmol/l the highest. The venous group had a range of 2.7mmol/l, with the lowest value being 4.1mmol/l and 7.0mmol/l the highest.For the primary research question, the mean BGL for the venous sample group was 5.3mmol/l (SD = 0.6), compared to 5.6mmol/l (SD = 0.8) for the capillary group. This represented a statistically significant difference of 0.3mmol/l (P = .04), but it did not reach the a priori established point of clinical significance (1.0mmol/l). Pearson’s correlation coefficient for capillary versus venous indicated moderate correlation (r = 0.42).Conclusion:In healthy, non-fasted people in a non-clinical setting, a statistically significant, but not clinically significant, difference was found between venous- and capillary-derived BGL when measured using a point-of-care, capillary-based glucometer. Correlation between the two was moderate. In this context, using venous samples in a capillary-based glucometer is reasonable providing the venous sample can be gathered without exposure of the clinician to risk of needle-stick injury. In clinical settings where physiological derangement or acute illness is present, capillary sampling would remain the optimal approach.

Reliability of Point-of-Care Capillary Blood Glucose Measurements in the Critical Value Range

2014 ◽  
Vol 138 (7) ◽  
pp. 962-966 ◽  
Author(s):  
Ron B. Schifman ◽  
Tan T. Nguyen ◽  
Susan T. Page
Keyword(s):  
Point Of Care ◽  
Venous Blood ◽  
Capillary Blood ◽  
Convenience Sample ◽  
Critical Range ◽  
Significant Difference ◽  
Patients With Diabetes ◽  
Value Range ◽  
Blood Specimens ◽  
One Year

Context.—Point-of-care glucose (POCG) testing on capillary blood specimens is central to maintaining glycemic control in patients with diabetes. Although there are known performance issues with POCG methods, especially for maintaining tight glucose control, there is little information about the accuracy of results in the critical ranges that may involve life-threatening conditions. Objectives.—To evaluate the reliability of POCG measurements in critical, high (&gt;600 mg/dL) and low (&lt;40 mg/dL) ranges. Design.—One-year retrospective analysis of POCG (ACCU-CHEK glucose meter, Roche Diagnostics Corporation, Indianapolis, Indiana) results for routine patient care were obtained. The frequency and accuracy of repeat testing after critical POCG results was analyzed. A convenience sample of noncritical capillary POCG measurements retested on venous blood specimens by another point-of-care device (RAPIDPoint 405 analyzer, Siemens Medical Solutions USA, Malvern, Pennsylvania) was also evaluated. Results.—Critical values were observed in 2.4 per 1000 POCG tests (256 of 105,928; 0.24%), with the highest rate (76 of 2289; 3.32%) from the emergency department. Twice as many critical high values as critical low values were seen. Nearly 80% of critical POCG tests (204 of 256) were repeated within 10 minutes. Of these 204 repeat measurements, 112 (54.9%) met accuracy criteria (±15 mg/dL of low and ±20% of high initial values). Accuracy was significantly higher when retesting was performed on the same meter or by the same operator (P ≤ .05). Comparison of capillary and venous POCG testing of noncritical results showed no significant difference (P = .95), with 89.8% (125 of 139) meeting accuracy criteria. Conclusions.—POCG measurements in the critical range are frequently erroneous, which is likely caused by preanalytic factors associated with sampling capillary blood. POCG testing practices should include retesting to confirm critical results.

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