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 Table of Contents  
ORIGINAL ARTICLE
Year : 2021  |  Volume : 6  |  Issue : 2  |  Page : 193-197

Comparison of two techniques used for the evaluation of point-of-care methodology for testing hemoglobin in blood donors


1 Department of Blood Transfusion Medicine, Sir Ganga Ram Hospital, New Delhi, India
2 Department of Research, Sir Ganga Ram Hospital, New Delhi, India

Date of Submission26-May-2021
Date of Decision14-Sep-2021
Date of Acceptance17-Sep-2021
Date of Web Publication30-Nov-2021

Correspondence Address:
Dr. Rashmi Rana
Department of Research, Sir Ganga Ram Hospital, New Delhi
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/gjtm.gjtm_47_21

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  Abstract 


Background and Objectives: Precise measurement of Haemoglobin(Hb) is necessary before the blood donation procedure for donor's protection against anemia and to ensure blood elements' quality to ensure the better effect of these blood constituents on the clinical outcomes of recipients. This is a comparative analysis of DiaSpect Tm and AccuSure hemoglobin (Hb) for point-of-care technique (POCT) for testing of Hb and to evaluate their effectivness by using venous blood as sample and Sysmex XP100 cell counter as the reference method. Methods: A total of 544 samples of blood donors between the age group 18 and 65 years were taken for this study. Measurement of Hb was done with the use of three different Hb analyzers – DiaSpect Tm, AccuSure Hb (Model HB101), and Sysmex XP100 Cell counter by using venous blood samples. P < 0.001 was taken statistically significant. Results: AccuSure Hb was found to have lower sensitivity in Hb estimation in the donor's blood compared to that of the DiaSpect Tm analyzer. Among various available techniques, there is a requirement to find a more appropriate technique for the estimation of Hb in the donor's blood. Conclusion: We found that DiaSpect Tm has greater sensitivity in comparison to AccuSure Hb. Furthermore, specificity, positive predictive value, negative predictive value, and accuracy of DiaSpect Tm were greater in comparison to those of AccuSure Hb.

Keywords: AccuSure-Hb 101, blood, DiaSpect Tm, hemoglobin measurement, Sysmex XP100


How to cite this article:
Ranjan V, Rana R, Kant R, Khillan K. Comparison of two techniques used for the evaluation of point-of-care methodology for testing hemoglobin in blood donors. Glob J Transfus Med 2021;6:193-7

How to cite this URL:
Ranjan V, Rana R, Kant R, Khillan K. Comparison of two techniques used for the evaluation of point-of-care methodology for testing hemoglobin in blood donors. Glob J Transfus Med [serial online] 2021 [cited 2022 Aug 10];6:193-7. Available from: https://www.gjtmonline.com/text.asp?2021/6/2/193/331612




  Introduction Top


Precise measurement of hemoglobin (Hb) is necessary before the blood donation procedure for donor's protection against anemia and to ensure blood constituents' quality to make sure the better effect of these blood constituents on the health of recipients. Donation of a single unit of blood results in a 1–1.5 g/dL drop of Hb in donor. Hence, an accurate method is needed to determine Hb in donor's blood to eliminate the chances of anemia in donor and to avoid unneeded delay in blood donation.[1] From ancient times, the copper sulfate method had been used as a qualitative method and beside copper sulfate method, various methods are available for the estimation of Hb. Each method of Hb estimation has its pros and cons.[2] Portable hemoglobinmeters are a modern quantitative method to estimate Hb in blood donors. Among various available techniques, there is a requirement to find a more suitable technique for testing Hb in the donor's blood.[3],[4] Anemia is mainly detected by determining Hb concentration by using a cell counter.[5] Although a number of traditional techniques are available to determine Hb concentration in donor's blood, point-of-care technique (POCT) which uses capillary and venous blood can be used as a screening method for the estimation of Hb in donor's blood. POCT testing is useful due to its ability of rapid and accurate testing. POCTs used for the estimation of Hb in donor's blood must be reliable, correct, user friendly, specific, sensitive, economic, and valid for exact estimation of Hb. To ensure donor's safety and sufficient availability of blood, various cutoff criteria have been outlined for different inhabitants.[6],[7],[8],[9],[10],[11],[12] [Table 1] shows the cutoff criteria outlined for different inhabitants. The cutoff criteria are diverse in nature, with the reason being that Hb level varies with sex, race, age, altitude, site of the sample, and cigarette smoking.[13] Hb level may also vary by vascular compartment, i.e., venous or capillary, and type of specimen and position of donor, i.e., standing or recumbent. Estimation of Hb is the mandatory test that is performed before blood donation. Despite the various techniques available for the estimation of Hb, no single technique has been found most appropriate and perfect to estimate Hb in donor's blood prior to blood donation.[14],[15]
Table 1: Cutoff criteria outlined for different inhabitants

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Aims and objectives

In this study, we compare two methods used for testing Hb and evaluate the effectivity of DiaSpect Tm and AccuSure Hb for POCT using venous blood as sample and Sysmex XP100 cell counter as the reference method.


  Materials and Methods Top


The samples were taken from 544 blood donors who visited the blood center based in a tertiary care hospital for the donation of blood from November 2019 to January 2020.

Ethical clearance

The study was cleared by the institutional review board of Sir Ganga Ram Hospital, Delhi. After taking a signed consent, venous samples were collected from blood donors prior to blood donation, which were used for the estimation of Hb in the donor's blood. Dipotassium ethylenediaminetetraacetic acid–K2 vials were used to collect the blood sample (2 mL) under identical conditions for testing Hb. The samples were run immediately or within 30–60 min on all the three types of equipment after collection. The collection of blood samples and estimation of Hb by using all the three methods were carried out by a single trained operator to avoid any inter-observer variability. Standardized control reagents provided by the manufacturer were used for equipment calibration and to control equipment quality. Blood donors were screened as per the DGHS criteria. Three different methods of automated hematology cell analyzer (Sysmex XP100 Japan), DiaSpect Tm (DiaSpect Medical GmbH, EKF Diagnostics Holding plc, Cardiff, UK), and AccuSure Hb (Microgene Diagnostic System Pvt. Ltd, OEM Sejoy Electronics and Instrument Company Ltd, model No. HB 101) were used for the estimation of Hb. DiaSpect Tm analyzer utilizes a broad-spectrum, multi-chromic sensor which measures the absorbance of the whole blood filled in a disposable reagent-free cuvette over a wide spectral range, whereas in AccuSure Hb101, an Hb strip is used with the AccuSure Hb meter as an analyzer for quantitative measurement of Hb. The portable meter analyzes the intensity and color of light reflected from the reagent area of the test strip. The strip uses the dry chemistry method – Azide methemoglobin.

Inclusion criteria

  • Individuals who visited the hospital's blood bank for blood donation
  • Blood donors within the age group of 18–65 years.


Exclusion criteria

  • Samples kept at room temperature for more than 1 h were excluded
  • Samples without donor consent were excluded.


Statistical analysis

A laboratory register was used to record the results, and the results were also reproduced into a spreadsheet of SPSS 17.0. (SPSS (HANGZHOU SEJOY ELECTRONICS & INSTRUMENTS CO.LTD, West Lake Economy & Technology Zone, Hangzhou, China. Diaspect Medical GmbH, Ebendorfer Chaussee Barleben, GERMANY). Statistical Package for the Social Sciences. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) of DiaSpect Tm and AccuSure Hb were compared with Sysmex XP analyzer (as reference method). P < 0.001 was taken statically significant. Bland–Altman was plotted to show the agreement between two methods, which correlated with Sysmex XP100 cell counter. Pearson's correlation coefficient was used to determine the strength of relationship between DiaSpect Tm with Sysmex XP analyzer (reference method) and AccuSure Hb with Sysmex XP analyzer (reference method).


  Results Top


A total of 544 samples of blood donors between the age group 18 and 65 years were recruited in this study. [Figure 1] shows the frequency of samples based on the age of blood donors. Out of the total 544 samples, 17 samples using Sysmex XP were found with Hb value less than the required level of 12.5 g/dL. In addition, 17 samples using DiaSpect Tm had Hb value below the required level of 12.5 g/dL and 22 samples using AccuSure Hb 101 had Hb value below the required level of 12.5 g/dL. DiaSpect Tm was found to had greater sensitivity (99.2%), specificity (86.7%), PPV value (99.6%), NPV value (76.5%), and accuracy (98.9%) when compared to those of Sysmex XP 100 analyzer. Seven samples using AccuSure Hb 101 had Hb values less than the required level of 12.5 g/dL when compared to that of Sysmex XP 100 analyzer. AccuSure Hb showed slightly lower sensitivity (98.3%), specificity (86.7%), PPV (99.6%), NPV (59.1%), and accuracy (98.0%) when compared to those of Sysmex XP 100 analyzer [Table 2]a and [Table 2]b. Two samples showed Hb >12.5 g/dL on both equipment, and the same samples showed Hb <12.5 g/dL on Sysmex [Table 2]a.
Figure 1: Frequency of samples based on the age of the blood donors

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[Figure 2] shows the correlation coefficient of two methods, which was determined with respect to the reference method (Sysmex XP). [Table 3] shows the parameters for this analysis, which indicates that every pair had a strong correlation coefficient (0.874–0.740). This result was somewhat expected because both methods were designed to measure the same parameter (Hb level in g/dL). Bland–Altman plot showed the agreement of two different techniques using DiaSpect Tm and AccuSure Hb 101 methods using Sysmex XP 100 analyzer as reference method. Bland–Altman plot uses both difference and average between two techniques to make plots, as shown in [Figure 3]a and [Figure 3]b.
Figure 2: (a) Coefficient correlation analysis of the hemoglobin between Diaspect and Sysmex (reference method). Coefficient correlation analysis of the hemoglobin between Accusure and Sysmex (reference method). (b) Coefficient Correlation analysis of the hemoglobin between Accusure and Sysmex (reference method)

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Table 3: Parameters for this analysis which indicate that every pair had a strong coefficient of correlation (range: 0.874-0.70)

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Figure 3: (a) Bland–Altman graphs between the average of Diaspect and Sysmex and difference between Diaspect and Sysmex (reference method). (b) Bland–Altman graphs between the average of Accusure and Sysmex and difference between Accusure and Sysmex (reference method)

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  Discussion Top


Suitable Hb testing methods should be available for the collection of blood to ensure the availability of the appropriate amount of blood by avoiding unneeded deferrals. The capillary method is used to estimate Hb prior to blood donation in laboratories, but in this study, venous sample was found to have homogeneity and near-true values because our reference method was based on the venous sample. Performance measures such as specificity, sensitivity, NPV, and PPV yield finer results with venous blood samples in comparison to capillary samples. Several reports found that Hb level is overvalued by capillary blood samples.[13],[16] The reason behind these overestimated values of Hb is that capillaries have arterial sources which have an increased amount of Hb in comparison to venous blood.[17]

Various methods are available for the estimation of Hb, and each method of Hb estimation has its pros and cons.[18],[19],[20],[21],[22],[23],[24],[25],[26] Therefore, we compared DiaSpect Tm and AccuSure Hb to find out a more specific and sensitive method for Hb estimation. We found that 99.2% (n = 525) out of the 529 selected blood donors who had Hb value ≥12.5 g/dL reference value passed DiaSpect evaluation, whereas 98.3% (n = 520) out of the total 529 selected blood donors who had Hb value ≥12.5 g/dL reference value passed AccuSure evaluation. Nearly 0.8% (n = 4) of the donors failed during Hb screening by DiaSpect Tm, whereas 1.7% (n = 9) donors failed during Hb screening by AccuSure Hb. Our study found that DiaSpect Tm has more accuracy, i.e., 98.9% in comparison to AccuSure, i.e., 98.0%. Furthermore, the sensitivity of DiaSpect Tm is greater, i.e., 98.3% in comparison to AccuSure Hb. Two samples showed higher values of Hb (>12.5 g/dL) on both the equipment (DiaSpect Tm and AccuSure Hb 101) as compared to the reference equipment (Sysmax) which showed values <12.5 g/dL.

Automated hematology analyzers are highly precise and accurate to determine Hb concentration. Blood donor's screening method should be reliable, correct, user friendly, specific, sensitive, economic, and valid for the exact estimation of Hb. DiaSpect Tm and AccuSure Hb are reliable, correct, user-friendly, specific, sensitive, and economic methods, which give accurate results in a short span of time. In this study, we compared DiaSpect Tm and AccuSure for POCT for testing of Hb and to evaluate their effectivity to find out a more reliable and accurate method for the selection of blood donors. We found DiaSpect to be more accurate and reliable than AccuSure Hb.

To ensure donor's safety and sufficient availability of blood, various cutoff criteria have been outlined for different inhabitants, but in addition to these cutoff criteria, research should focus on finding a more suitable technique which has a standard protocol for every blood collection center to use in the blood testing of Hb in donor's blood. Noninvasive devices are currently gaining more attention as they have user-friendly, pain-free, portable, and less time-consuming options for blood donors as well as health professionals and are especially useful for blood donation camps and centers with high-donor footfall.


  Conclusion Top


It can be said that two POCT methodologies are suitable for testing Hb in the selection of healthy blood donors. However, both methods can be useful as a sole procedure for the screening of blood donors.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

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Smith GA, Fisher SA, Dorée C, Roberts DJ. A systematic review of factors associated with the deferral of donors failing to meet low haemoglobin thresholds. Transfus Med 2013;23:309-20.  Back to cited text no. 1
    
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Drug and Cosmetic Act, 1940 and The Drug and Cosmetic Rule; 1945, Amendment up to 2013. Available from: https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf documents/acts_rules/2016DrugsandCosmeticsAct1940Rules1945.pdf.  Back to cited text no. 10
    
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    Figures

  [Figure 1], [Figure 2], [Figure 3]
 
 
    Tables

  [Table 1], [Table 2], [Table 3]



 

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