Assessment of the diagnostic performance of TrueHb® point-of-care hemometer compared with Sysmex i3 analyzer among patients at International Hospital Kampala, Uganda

Abstract

Aim/Objective: To assess the diagnostic performance of TrueHb® point-of-care (POC) hemometer compared with Sysmex i3 analyzer at International Hospital Kampala, Uganda.

Materials and methods: We analyzed ethylenediaminetetraacetic acid blood samples to estimate hemoglobin (Hb) levels using parallel testing with TrueHb® hemometer and Sysmex i3 analyzer. Data were analyzed to ascertain the diagnostic performance of the test assays using the Bland and Altman method. Sensitivity, specificity, positive and negative predictive values were calculated.

Results: The study enrolled 402 patients; of these, 156 (38.8%) were males. The average Hb levels were 8.7±1.8 and 13.3±2.6 g/dL for the anemic and nonanemic patients, respectively. One hundred and fifty-five participants were anemic, giving anemia prevalence of 38.56% (95% CI: 35.17–40.38). The mean difference of the TrueHb® and Sysmex i3 assays was 2.2219 (SD 1.07915), and the two devices did not show a difference in their measurements (t=−2.407, p-value 0.017, 95% CI: −0.095–0.010). Further, they showed a significant level of agreement (t=41.281; 95% CI: 2.1161–2.3277) and intraclass correlation coefficients (ICC=0.793). The sensitivity, specificity, positive and negative predictive values were 100.00%, 51.01%, 55.16% and 100.00%, respectively. The average performance turnaround time (TAT) for the TrueHb® hemometer was 2.46 mins (95% CI: 2.37–2.55).

Conclusion: TrueHb® POC hemometer is an accurate POC for Hb estimation with a good performance agreement with the Sysmex i3 analyzer. This, coupled with its utility aspects, makes it a good diagnostic tool in a high anemia burden and low-resource setting.

Keywords:

• anemia
• hemoglobin estimation
• point-of-care testing
• TrueHb®
• Sysmex i3
• Uganda

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Assessment of the diagnostic performance of TrueHb® point-of-care hemometer compared with Sysmex i3 analyzer among patients at International Hospital Kampala, Uganda [Corrigendum]

Acknowledgments

We are indebted to the laboratory staff of Lancet Laboratories, International Hospital Kampala branch for the assistance accorded during the time of data collection. We also acknowledge the logistic support from Wrig Nanosystems, India, who provided the evaluation products, and Reliable Diagnostic Supplies paid for the logistics. This study did not receive any funding for this study.

Author contributions

All authors contributed to data analysis, drafting or revising the article, gave final approval of the version to be published, and agree to be accountable for all aspects of the work.

Disclosure

The principal investigator received a generous donation of the TruHb® hemometer and the test strips from the manufacturer (Wrig Nanosystems, India); however, this did not in any way interfere with the test method, results obtained, interpretation of the results as well as the decision to publish. The authors report no other conflicts of interest in this work.