International Journal of Current Research and Review
ISSN: 2231-2196 (Print)ISSN: 0975-5241 (Online)
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IJCRR - vol 05 issue 05, March, 2013

Pages: 105-110

Date of Publication: 22-Mar-2013


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INTERNAL QUALITY CONTROL FOR ERYTHROCYTE SEDIMENTATION RATE USING PATIENT BLOOD SAMPLE

Author: Asha Patil, Deepak Nayak M., Sushma V. Belurkar

Category: Healthcare

Abstract:The erythrocyte sedimentation rate (ESR) test continues to be used as an important tool in many laboratories; either manually or as automated method. When automation is applied in clinical laboratories, it is imperative that reliable methods for calibration and appropriate control materials are available for monitoring the accuracy and precision of the results generated. But when the commercial control degenerates or is unavailable, alternative sources such as patient blood can be an alternative. Aims: a.To assess the usefulness of ESR values of patients' sample in maintaining internal quality control. b. To use the patient blood sample in order to ascertain the precision of the ESR test results on two machines: Diesse Ves- MATIC 80\? (machine A and B).Materials and Methods: A retrospective cross-sectional study involving 219 blood samples over a period of 8 months was conducted at Kasturba Hospital, Manipal. The patient samples with normal (< 10 mm/hr) ESR (Group 1) and the patient samples with abnormal (>60 mm/hr) ESR (Group 2) were run on the 2 Diesse Ves- MATIC 80\? machines (A andB) against two level commercial controls on a daily basis. Statistics: Bland and Altman statistical analysis was applied for evaluating comparability of the methodologies. Results: Both groups showed a good concordance for all the ESR values and they were within 2SD. The results of higher ESR values were much better than the lower ESR values. Conclusions: The fresh patient blood samples as an internal quality control material showed good precision.

Full Text:

INTRODUCTION
Estimation of the erythrocyte sedimentation rate (ESR) has a long-standing history and tradition in clinical laboratories.1 ESR, the most widely used laboratory measure of disease activity in clinical medicine, is still considered useful for monitoring inflammatory diseases, rheumatoid arthritis in particular.2 Recent literature reviews and studies indicate that this test is widely used both for the diagnosis and follow-up of patients with many clinical conditions.3-6 In recent decades, several new techniques for measuring ESR have been developed and introduced in clinical laboratories in order to guarantee safety to technicians and other operators by using automated and closed systems; to automate the measurement itself and optimize the workflow and the utilization of human resources and to create a unique workstation for measuring ESR and performing other hematologic tests (eg: erythrocyte, leukocyte, and reticulocyte concentrations) in a single specimen. This should be done, as suggested by the International Council for Standardization in Haematology (ICSH) and the National Committee for Clinical Laboratory Standards (NCCLS), by using the recommended specimen, undiluted blood with tri-potassium (K3) EDTA, which is more reliable than the traditional sodium citrate.7,8 In an era where quality assurance and accreditation of medical laboratories is fast gaining precedence, attention to details should be given to the issue of quality control and quality assurance for ESR measurement. Because the human erythrocyte sedimentation reaction is confined to fresh blood and is transient, reference or control materials of the usual type are not available.9 Stabilized specimens of human or nonhuman origin cannot be considered acceptable in place of fresh human blood or suitable for use in methods which measure the kinetics of RBC sedimentation, not simply the final fall of RBCs after a fixed time.9 In order to maintain reliable, accurate and satisfactory results, internal control is imperative. The quality measures can be used to monitor various aspects of test like systemic error or technical error. With regard to ESR, commercial controls are made available by the manufacturers. In case of non-availability or deterioration of commercial controls, patients’ whole blood has been used for the daily quality control of ESR in clinical laboratories.9

AIMS AND OBJECTIVES
The study was conducted with the following primary objectives: a. To assess the usefulness of ESR values of patients sample in maintaining internal quality control. b. Using patient blood sample to ascertain the precision of the ESR test results on two machines -Diesse Ves-MATIC 80™ (machine A and B).

MATERIALS AND METHODS
The study design was a retrospective crosssectional type, involving 219 blood samples over a period of 8 months conducted at Clinical Laboratory and Haematology division, Kasturba Hospital, Manipal. An approval from the Institutional Ethics Committee, Kasturba Hospital, Manipal was obtained before the study. Inclusion Criteria Patients of both sexes and all age groups were included in the study. Exclusion Criteria Blood samples which were not in proper proportions to the anticoagulant, strongly lipemic, hyperbilirubinemic and hemolyzed samples were excluded. The 219 patient samples were assessed for the study on two ESR machines -Diesse Ves-MATIC 80™ (machine A and B) A total of 219 patient samples were assessed for the study on two ESR machines -Diesse Ves MATIC 80™ (machine A and B) on daily basis along with commercial controls supplied by the machine providers. The study was divided into 2 groups: Group 1: Patient samples with normal (60 mm/hr) ESR Commercial controls were of two levels, normal (range 3-10 mm/hr) and abnormal (range 55-85 mm/hr).

STATISTICAL ANALYSIS
The statistical analysis of data was carried out using MS Excel ’98 software (Microsoft, Seattle, WA). Additional statistical analysis was performed using SPSS 16.0 for Windows (SPSS Inc., Chicago, IL, USA). The method comparison and the differences between ESR values from day to day were performed by using Bland-Altman method in order to measure the comparability of the methods. Average ESR results of 219 patients samples with both the ranges on both the machines were plotted against the difference between them. The 95% limits of agreement were calculated as d ± 1.96 SD where d = mean difference between the two measurements; and SD = standard deviation of differences.

RESULTS
Group 1: Patient samples with Normal ESR on two Diesse VesMATIC 80™ machines. Mean of the ESR results of 219 patients samples with the range [0-10 mm/hr] on both the machines were plotted against the difference between them (Fig.1).

 

The mean difference between the two machines for lower values was found to be -0.315± 1.64 (95% limits of agreement, -3.56 to 2.97). The ESR readings for 95 % of the samples (IQC) on two machines [Diesse Ves-MATIC 80™ (A and B)] were within 2 standard deviation i.e., -3.56 mm/hr below or +2.97 mm/hr above it.

 

Group 2: Patient samples with Abnormal ESR on two Diesse Ves-MATIC 80™ machines. Mean of the ESR results of 219 patients samples with the range [>60 mm/hr] on both the machines were plotted against the difference between them (Fig.2).

The mean difference between the two machines for higher values was found to be -0.977±5.01 (95% limits of agreement, -10.997 to 9.43). The ESR readings for 95 % of the samples (IQC) on two machines [Diesse Ves-MATIC 80™ (A and B)] were within 2 standard deviation i.e.,-10.997 mm/hr below or +9.43 mm/hr above it.

DISCUSSION
Erythrocyte sedimentation rate continues to be used as an indicator of inflammation and infection in all levels of laboratory services; despite being a non-specific test. The gold standard technique for measuring ESR is the Westergren method. However, this method has distinct disadvantages which limit its applications.10 Over the years, several attempts to introduce automated systems for measuring ESR have evolved. The modifications introduced include the use of unopened blood collection tubes, vacuum-controlled aspiration of the sample (which intends to provide a correct dilution with the anticoagulant) and automated mixing.11-14 Due to the rise in the prevalence of diseases such as hepatitis B and HIV, transmitted by blood, safety precautions against contamination of laboratory personnel are imperative. Several automated systems have been introduced since the last two decades and have been evaluated for performance with each other as well as with the standard Westergren method. These automated techniques offer more benefits in terms of reduced biohazard risks, speedy processing time, and quicker results. Using an automatic analyzer is one such evolutionary step in this regard. Recently, we evaluated and validated a new automated measurement procedure, the Diesse Ves-MATIC 80TM , that allows automated, safe, precise, and accurate measurement of the ESR in clinical practice. The advantages of using this technique include the aforementioned. However, the major advantage conferred by this machine is its use of undiluted K3 EDTA-anticoagulated samples to measure ESR. It is well known that ESR is affected mainly by RBC aggregation or rouleaux formation. The collection of specimens with K3EDTA is known to maintain blood cell stability, thus favoring rouleaux formation, preserving the morphologic features and this is of crucial importance in the ESR reaction.15 However, in an era dominated by quality assurance and accreditation of medical laboratories, greater attention should be given to the issue of quality control for ESR measurement. The commercial controls provided by the manufacturers do address this issue. In case of non-availability or deterioration of commercial control however, the alternatives are scarce. Moreover, the nature of the human erythrocyte sedimentation reaction is such that a suitable reference or control material of the usual type is not available in the market. Although several stabilized specimens of human origin have been introduced in clinical laboratories, their kinetic properties, which are different from those of fresh blood erythrocytes, preclude their use for ESR determination. In the year 2000, NCCLS suggested that the only feasible way of providing a control material is to specify a method for the production of such material in the laboratory where it is to be used.8 Recently, Plebani and Piva successfully evaluated a quality control procedure that uses fresh whole blood specimens on the machine (TEST1EC). 9 Thus, we decided to use the patient EDTA sample for internal quality control (IQC) of ESR. In the present study, we found that both the groups (i.e. patients with low and high ESR) showed a good concordance for all the ESR values when they were run alongside two level commercial controls. Also, they were within 2 standard deviation (SD). It was also noticed that the results of higher ESR values concurred better than the lower ESR values.

CONCLUSIONS
In our study, the use of fresh patient blood sample as an internal quality control material showed good precision. While quality control has been neglected and considered irrelevant unimportant for tests such as ESR, efforts are necessary to assure that adequate control materials and procedures are provided. Our results, obtained in patient blood samples, demonstrate that the quality control for the measurement of ESR is feasible, inexpensive and reliable. In case of non-availability or deterioration of commercial control, patient’s sample is a useful substitute. This procedure is easily to perform and can be monitored. Many more studies would be necessary to ensure reliability of this method.

References:

1. Piva E, Sanzari MC, Servidio G, et al. Length of sedimentation reaction in undiluted blood (erythrocyte sedimentation rate): variations with sex and age and reference limits. Clin Chem Lab Med. 2001; 39:451-454.

2. Wolfe F, Pincus T. The level of inflammation in rheumatoid arthritis is determined early and remains stable over the long-term course of the illness. J Rheumatol. 2001; 28:1817 - 1824.

3. Cantini F, Salvarani C, Olivieri I, et al. Erythrocyte sedimentation rate and Creactive protein in the evaluation of disease activity and severity in polymyalgia rheumatica: a prospective follow-up study. Semin Arthritis Rheum.2000; 30:17-24.

4. Brigden ML. The erythrocyte sedimentation rate: still a helpful test when used judiciously. Postgrad Med.1998; 103:257-274.

5. Saadeh C. The erythrocyte sedimentation rate: old and new clinical application. South Med J. 1998; 91:220-225.

6. Wolfe F, Michaud K. The clinical and research significance of the erythrocyte sedimentation rate. J Rheumatol.1994; 21:1177-1178.

7. International Council for Standardization in Haematology. ICSH recommendation for measurement of erythrocyte sedimentation rate. J Clin Pathol.1993; 46: 198-203.

8. National Committee for Clinical Laboratory Standards. Reference and Selected Procedure for Erythrocyte Sedimentation Rate (ESR) Test; Approved Standard, 4th ed. H2-A4. Villanova, PA: NCCLS; 2000.

9. Plebani M, Piva E. Erythrocyte Sedimentation Rate: Use of Fresh Blood for Quality Control. Am J Clin Pathol 2002; 117:621-626.

10. Atas A, Cakmak A, Soran M, Karazeybek H. Comparative study between the Ves-Matic and Micro erythrocyte sedimentation rate method. J Clin Lab Anal 2008; 22:70-72.

11. Patton WN, Meyer PJ, Stuart J. Evaluation of sealed vacuum extraction method (Seditainer) for measurement of erythrocyte sedimentation rate. J Clin Pathol 1989; 42:313-317.

12. Besson I, Kinder M, Jou JM, Vives Corron JL. The evaluation of three automatic systems for determining the velocity of globular sedimentation. Blood 1995; 40:103- 107.

13. Plebani M, De Toni S, Sanzari MC, Bernardi D, Stockreiter E, et al. The TEST1 automated system: A new method for measuring the erythrocyte sedimentation rate. Am J Clin Pathol 1998; 110:334-340.

14. Fernandez de Castro M, Fernandez Calle P, Viloria A, Larrocha C, Jimenez MC. Evaluation of a fully automated system for determination of the erythrocyte sedimentation rate. Blood 1989; 34:1-9.

15. Horsti J, Kovanen M. Using EDTA as an anticoagulant for ESR to replace citrate. Kliin Lab. 2000;4:97-100.

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One article from every issue is selected for the ‘Best Article Award’. Authors of selected ‘Best Article’ are rewarded with a certificate. IJCRR Editorial Board members select one ‘Best Article’ from the published issue based on originality, novelty, social usefulness of the work. The corresponding author of selected ‘Best Article Award’ is communicated and information of award is displayed on IJCRR’s website. Drop a mail to editor@ijcrr.com for more details.

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Best Article Award

A Study by Jabbar Desai et al. entitled "Prevalence of Obstructive Airway Disease in Patients with Ischemic Heart Disease and Hypertension" is awarded Best Article for Vol 12 issue 17
A Study by Juna Byun et al. entitled "Study on Difference in Coronavirus-19 Related Anxiety between Face-to-face and Non-face-to-face Classes among University Students in South Korea" is awarded Best Article for Vol 12 issue 16
A Study by Sudha Ramachandra & Vinay Chavan entitled "Enhanced-Hybrid-Age Layered Population Structure (E-Hybrid-ALPS): A Genetic Algorithm with Adaptive Crossover for Molecular Docking Studies of Drug Discovery Process" is awarded Best article for Vol 12 issue 15
A Study by Varsha M. Shindhe et al. entitled "A Study on Effect of Smokeless Tobacco on Pulmonary Function Tests in Class IV Workers of USM-KLE (Universiti Sains Malaysia-Karnataka Lingayat Education Society) International Medical Programme, Belagavi" is awarded Best article of Vol 12 issue 14, July 2020
A study by Amruta Choudhary et al. entitled "Family Planning Knowledge, Attitude and Practice Among Women of Reproductive Age from Rural Area of Central India" is awarded Best Article for special issue "Modern Therapeutics Applications"
A study by Raunak Das entitled "Study of Cardiovascular Dysfunctions in Interstitial Lung Diseas epatients by Correlating the Levels of Serum NT PRO BNP and Microalbuminuria (Biomarkers of Cardiovascular Dysfunction) with Echocardiographic, Bronchoscopic and HighResolution Computed Tomography Findings of These ILD Patients" is awarded Best Article of Vol 12 issue 13 
A Study by Kannamani Ramasamy et al. entitled "COVID-19 Situation at Chennai City – Forecasting for the Better Pandemic Management" is awarded best article for  Vol 12 issue 12
A Study by Muhammet Lutfi SELCUK and Fatma COLAKOGLU entitled "Distinction of Gray and White Matter for Some Histological Staining Methods in New Zealand Rabbit's Brain" is awarded best article for  Vol 12 issue 11
A Study by Anamul Haq et al. entitled "Etiology of Abnormal Uterine Bleeding in Adolescents – Emphasis Upon Polycystic Ovarian Syndrome" is awarded best article for  Vol 12 issue 10
A Study by Arpita M. et al entitled "Estimation of Reference Interval of Serum Progesterone During Three Trimesters of Normal Pregnancy in a Tertiary Care Hospital of Kolkata" is awarded best article for  Vol 12 issue 09
A Study by Ilona Gracie De Souza & Pavan Kumar G. entitled "Effect of Releasing Myofascial Chain in Patients with Patellofemoral Pain Syndrome - A Randomized Clinical Trial" is awarded best article for  Vol 12 issue 08
A Study by Virendra Atam et. al. entitled "Clinical Profile and Short - Term Mortality Predictors in Acute Stroke with Emphasis on Stress Hyperglycemia and THRIVE Score : An Observational Study" is awarded best article for  Vol 12 issue 07
A Study by K. Krupashree et. al. entitled "Protective Effects of Picrorhizakurroa Against Fumonisin B1 Induced Hepatotoxicity in Mice" is awarded best article for issue Vol 10 issue 20
A study by Mithun K.P. et al "Larvicidal Activity of Crude Solanum Nigrum Leaf and Berries Extract Against Dengue Vector-Aedesaegypti" is awarded Best Article for Vol 10 issue 14 of IJCRR
A study by Asha Menon "Women in Child Care and Early Education: Truly Nontraditional Work" is awarded Best Article for Vol 10 issue 13
A study by Deep J. M. "Prevalence of Molar-Incisor Hypomineralization in 7-13 Years Old Children of Biratnagar, Nepal: A Cross Sectional Study" is awarded Best Article for Vol 10 issue 11 of IJCRR
A review by Chitra et al to analyse relation between Obesity and Type 2 diabetes is awarded 'Best Article' for Vol 10 issue 10 by IJCRR. 
A study by Karanpreet et al "Pregnancy Induced Hypertension: A Study on Its Multisystem Involvement" is given Best Paper Award for Vol 10 issue 09
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Awardees of COVID-19 Research

Woman Researcher Award

A Study by Neha Garg et al. entitled "Optimization of the Response to nCOVID-19 Pandemic in Pregnant Women – An Urgent Appeal in Indian Scenario" published in Vol 12 issue 09

A Study by Sana Parveen and Shraddha Jain entitled "Pathophysiologic Enigma of COVID-19 Pandemic with Clinical Correlates" published in Vol 12 issue 13

A Study by Rashmi Jain et al. entitled "Current Consensus Review Article on Drugs and Biologics against nCOVID-19 – A Systematic Review" published in Vol 12 issue 09

Emerging Researcher Award

A Study by Madhan Jeyaraman et al. entitled "Vitamin-D: An Immune Shield Against nCOVID-19" published in Vol 12 issue 09

Study by Dheeraj Kumar Chopra et al. entitled "Lipid-Based Solid Dispersions of Azilsartan Medoxomil with Improved Oral Bioavailability: In Vitro and In Vivo Evaluation" published in Vol 12 issue 19


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