1. EVALUATION OF HEMOCHROMA POC Hb READER
Investigators:
Mr. Francis M Wanyama 1, Prof Christine S. Kigondu1 and Dr. Peter Maturi2
Department of Human Pathology, School of Medicine, University of Nairobi, 1Clinical Chemistry Section, 2Hematology and BTU Section, P.O Box – 00202, Nairobi, Kenya.

2. INTRODUCTION
Boditech’s Hemochroma TM is a portable hemoglobin meter based on robust and reliable detection mechanism with proper handling.
It is capable of delivering excellent accurate measurements comparable to high end reference hemoglobin analyzers.

3. RATIONALE
GLP requires that all equipment upon installation should demonstrate the capability of achieving the performance required as well as complying with the specifications relevant to the tests concerned.
All methods have to be validated extensively in order to confirm that they are suitable for the intended use.
Laboratories are expected to carry out thorough investigations of their analyzer as part of method validation before they are put into use.

4. STUDY OBJECTIVE
To assess the performance of Boditec’s Hemochroma TM Point of care (POC) hemogloblin reader with respect to its level of accuracy.

5. MATERIAL AND METHODS
Test Equipment: Boditec’s hemochroma Hemochroma TM POC hemoglobin reader is developed for the quantitative assay of hemoglobin in human blood by standard cyanmethemoglobin method.

6. Comparative Equipment: aᶜ.T 5 differential CP analyzer Beckman
Principle:
It is a fully automated hematology analyzer providing a complete WBC five-part differential which is determined simultaneously by the ACV(absorbance, cytochemistry and volume technology ) and is focused flow impedance

7. Beckman HB measurement
It is based on transmittance of light through the optical part of the first dilution/Hb bath using spectrophotometric technique at wavelength of 550nm.
The transmittance of the sample dilution is compared to the transmittance of a reagent blank.
The system calculates the Hb using the blank and sample readings.

8. The cyanmethemoglobin method
The Hb released by lysis of RBC combines
with the potassium cyanide to form a stable
cyanmethemoglobin compound which is
measured through optical part of the first
dilution/Hb bath using spectrophotometric
technique at a wavelength of 550nm.

9. Table: Technical characteristics for measurement of Hb
Dilution characteristic 
Volume of whole blood µl
Volume of Aᶜ.T differential diluent µl
Preliminary dilution ratio :170
Volume of the 1:170 dilution removed(for making the RBC/platelet dilution) µl
Volume of Aᶜ.T 5 differential Hb lyse µl
Additional volume of Aᶜ.T 5 differential diluent - 400µl
Final dilution for Hb determination - 1:250
Reaction temperature ⁰C(95⁰F)
Methods of analysis - spectrophotometry
Wavelength nm 

10. RELATIVE ACCURACY
The comparative equipment used was Beckman coulter Ac TTM Haematology analyser PN c from Beckman coulter Inc, Fullerton, CA

11. STATISTICAL ANALYSIS
The data was analyzed statistically by use of SD, the CV and finally the results were subjected to the students ‘t’ test to test for variance and correlation. t = X1- X/SE
critical values also known as ‘t’ tabulated, which tests significance [P] was obtained from the standard statistical tables

12.   RESULTS
The Hb (g/dl) levels for 52 specimen as read on Beckman and Hemochroma TM POC and the resultant means, SD and CV%
Comparative Hb levels were obtained using factor -1.7 between the Beckman and Hemochroma.
Intra sample standard deviation obtained between the two machines were within 1 SD with mean SD of 0.4

13. Coefficient of variation (C. V%) ranged between 0 and 11
Coefficient of variation (C.V%) ranged between 0 and 11.0 per cent with only 8 points out of 52 giving above 6%.
The mean C.V was 3.2% which is within the acceptable of up to 6%
The student ‘t’ test gave P value of <0.0005, this shows that there is no significant statistical difference between the two methods

15. CONCLUSION
The mean levels of Hb (g/dl) for Beckman and Hemochroma POC was 12.1 and respectively with mean of both two level at 11.9 and 1SD of 0.4.
The student ‘t’ test showed P. value of < showing that the two means were not statistically different when a factor of -1.7 was used.
The correlation coefficiency [r] was 0.9 indicating that the two methods are highly correlated.

16. RECOMMENDATIONS
Periodic calibration should be inbuilt based on an internal quality control and/or reference methods.
The identified places where the machine can be of greater use includes Casualty Wards, Antenatal clinic, Medical clinics eg for Heamatological clinic, Research, Screening camps, Mobile clinics and Laboratories in the rural settings etc.

17. Thank you !!!
Thank You!!