EVALUATION OF THE VALIDITY OF HEMOCUE HB 201+ FOR PREDONATION ASSESSMENT OF LOW AND HIGH HAEMOGLOBIN LEVELS IN BLOOD DONORS: ONE YEAR PROSPECTIVE STUDY IN BLOOD BANK OF GMC DODA

find out the prevalence of anaemia in potential blood donors using HemoCue Hb 201+, the sensitivity and specificity of the device was reported to be 94.1% and 95.2% respectively 6 . Tondon R et al conducted a study to assess different methods of haemoglobin estimation in blood donors and found the sensitivity and specificity of HemoCue to be 99.4%and 84.4% respectively 7 .We found that sensitivity of detecting Hb<12.5g/dl was 64.71% for capillary samples and 58.82% for venous samples. al sensitivity, specificity and PPV for


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Introduction:-Pre donation assessment of hemoglobin is the most important test done on blood donors to determine their fitness for blood donation. The purpose of this test is to safeguard the potential donors to avoid taking blood from an anemic person. According to the standards mentioned by Drugs and Cosmetic Act of 1940, in order to accept a potential blood donor the haemoglobin levels should be more than 12.5 g/dL and hematocrit should be more than 38% 1 . Also it is unsafe for the recipient to use blood obtained from donors with high haemoglobin levels >16.5 g/dl in females and >18.5g/dl in males since the blood can be of poor quality.
The methods conventionally used for hemoglobin estimation in blood banks are CuSO4 gravimetric method and Hemoglobin colorimetric scale. Both of these methods are rapid, simple and inexpensive but they are qualitative or semiquantitative and can detect only low hemoglobin levels 2 and they are not suitable for detection of high hemoglobin levels.
Nowadays several methods of haemoglobin estimation are available which include; Cyanmethemoglobin method, Automated haematology analyser, Occlusion Spectroscopy and Pulse co-oximetry 3 . However the ideal method to be used in blood banks should be rapid, sensitive, accurate for both high and low haemoglobin values, portable and with less expertise needed to run the test.

Aim:
This study was performed with the main aim to assess the diagnostic accuracy of a rapid, quantitative method (HemoCue Hb 201+) for detection of both low and high haemoglobin levels in potential blood donors.

Materials And Methods:-
This was a prospective study done in blood bank of GMC Doda w.e.f 1 st April 2020 to 31 st March 2021. A total of 1214 potential blood donors were found fit for donation in our blood bank during this time period.

Exclusion criteria for blood donors:
Age <18 and >60 years, pregnant and lactating females, history of febrile illness, history of covid -19 positive test or covid vaccination in last 28 days, paid donor, history of any serious illness, history of major surgical procedure, history of blood transfusion in last 12 months, history of any recombinant, killed or toxoid vaccine.
Finger prick(capillary blood) samples were taken from all these potential donors and hemoglobin estimation was done using (HemoCue Hb 201+) after discarding the first drop of blood. Also venous samples obtained by venipuncture were collected in EDTA tubes and samples were run on Automated HaematologyAnalyser (Erba H560) and the values of haemoglobin were compared.The criteria for acceptance of blood donors was taken as hemoglobin concentration within the range of 12.5 to 18.5 g/dl in males and 12.5 to 16.5g/dl in females.
Out of 1214 potential blood donors only 1198 were selected as fit donors with haemoglobin in the range of 12.5g/dl to 18.5g/dl. The sensitivity, specificity, positive predictive values(PPV) and negative predictive values ( NPV) and accuracy of (HemoCueHb201+) for both low and high haemoglobin levels were determined using the following formulae:

Results:-
1214 potential blood donors were included in this study.
The values of haemoglobin obtained with HemoCue Hb 201+ were compared with the standard reference method (haematologyanalyser) and are summarised in Table I. HemoCue Hb 201+ showed that 11 potential blood donors had haemoglobin levels below 12.5 g/dL and were considered truly anaemic.
Taking into account high haemoglobin levels out of 10 potential blood donors who were rejected 06 were falsely rejected on basis of HemoCue Hb 201+.   We found that as haemoglobin levels increased, the discrepancy between the haemoglobin levels measured with HemoCue Hb 201+ and the reference method also increased.
In present study we found that at low haemoglobin levels, there was a strong correlation between HemoCueHb 201+ and automated haematologyanalyser measurements and this correlation was similar to that found in other studies. In our study, the specificity of HemoCue Hb 201+ method for screening of haemoglobin levels lower than 12.5 g/dL was found to be 100% for both capillary and venous samples. In a study conducted by Akhtar K et al to 373 find out the prevalence of anaemia in potential blood donors using HemoCue Hb 201+, the sensitivity and specificity of the device was reported to be 94.1% and 95.2% respectively 6 . Tondon R et al conducted a study to assess different methods of haemoglobin estimation in blood donors and found the sensitivity and specificity of HemoCue to be 99.4%and 84.4% respectively 7 .We found that sensitivity of detecting Hb<12.5g/dl was 64.71% for capillary samples and 58.82% for venous samples.
Taking into account sensitivity and specificity, the discriminating power for detecting anaemia was found to be greater for capillary samples than for venous samples.
Our results were comparable to results obtained by Hayedeh J. Shahshahani et al who reported sensitivity of HemoCue 201+ for capillary and venous samples as 79.4% and 64% respectively and specificity of 100% for both capillary and venous samples 8 .
We observed that as the haemoglobin level increased, the correlation between HemoCue and the standard method decreased, and at levels above 18.5g/dL, the correlation was not significant. Predominance of male blood donors and high altitude in the area where study was conducted, accounted for the high haemoglobin levels in blood donors. This accounted for high deferral rate among the blood donors using HemoCue Hb 201+. This warrants the need for using qualtitative methods of haemoglobin screening among blood donors. Accurate quantitative methods should be used when qualitative methods fail and when a portable and rapid Hb measurement is required for example in blood donation camps. However, the running cost of HemoCue is high compared to the traditional qualitative methods used.

Conclusion:-
We concluded that HemoCue Hb201+ combines the advantage of on-site testing with sufficient accuracy and rapidity. However a rapid haemoglobinometer should fulfill the basic criteria of economic and regulatory issues along with appropriate training and knowledge of staff regarding test requirements, performance and limitations. Also it was found that HemoCue Hb 201+ was suitable for screening of low haemoglobin levels better than higher haemoglobin levels, which explains why qualitative methods of haemoglobin assessment are still in use in bloodbanks.