Background:  In resource-limited settings patients are frequently started on stavudine (d4T) -containing regimens, which can lead to hyperlactatemia or lactic acidosis, a potentially fatal syndrome. At the Infectious Diseases Institute Ltd, Uganda 2634 of the 4440 patients (59%) on ART were started on d4T-containing regimens. Lactate measurements are often not available in resource-limited settings, and where available the test is expensive ($7) and hampered by long laboratory turn-around times (minimum 6 hours). Our objective was to validate a point-of-care hand-held lactate analyzer comparing it with our laboratory chemistry analyzer.

Methods:  The hand-held analyzer (Accutrend, Roche Diagnostics, Germany) uses chemistry test strips to which a drop of blood is applied. The turn-around time is 60 seconds and the price is approximately $226 for the machine, and $2.30 per test strip. Results obtained were compared to results from the hospital laboratory (Cobas Intergra, Roche Diagnostics, Germany). Pearson’s product moment correlation coefficient (r) was used to determine the degree of association between lactate concentrations derived from the hand-held analyzer and the hospital laboratory results. The level of agreement between the 2 methods was assessed using the methods described by Bland and Altman.

Results:  Serum lactate levels ranged from 1.1 to 6.7 mM/L. The mean lactate levels were 3.16 and 3.06 mM/L (hand-held analyzer and hospital laboratory respectively) and SD were 1.19 and 1.54 mM/L (hand-held analyzer and hospital laboratory respectively). There was a strong correlation (R² = 0.94; p <0.001; slope = 0.65) between the serum lactate concentrations obtained with the 2 methods of measurement. The bias (mean difference) was –0.064 mM/L (95%CI –0.239 to 0.112). Lactate measurements from the hand-held lactate analyzer machine were lower by 1.36 mM/L and higher by 1.23 mM/L, than those obtained by the reference machine (limits of agreement –1.361 to 1.234), and 95% of the measurements were within this range.

Conclusions:  The hand-held lactate analyzer can reliably be used in patients on ART with suspected hyperlactatemia at low cost and with short turn-around time. Use of point-of-care lactate analyzers should be considered in ART programs where majority of the patients are on d4T-containing regimens.