Performance verification of Mindray BS-2800M chemistry analyzer for detecting lactate dehydrogenase, albumin and adenosine deaminases in cerebrospinal fluid and evaluation of its diagnostic accuracy in central nervous system diseases

Background: Due to the lack of evidence that biochemical reagents can be used in the detection of cerebrospinal fluid (CSF) samples, medical laboratories shoulder the responsibility of investigating whether biochemical reagents for CSF samples comply with regulatory requirements for body fluid testing. This study aimed to examine the analytical performance and clinical diagnostic accuracy of Mindray biochemical reagents in detecting lactate dehydrogenase (LDH), albumin (ALB), and adenosine deaminase (ADA) in CSF samples. Methods: The repeatability, linearity, and positive judgment values of LDH, ALB, and ADA in CSF as detected by Mindray BS-2800M were evaluated. According to EP09, the methodological comparison was conducted between Mindray BS-2800M and reference measurement procedure [ultraviolet (UV) spectrophotometry]. The accuracy of LDH, ALB, and ADA in the auxiliary diagnosis of central nervous system (CNS) diseases was assessed using receiver operating characteristic (ROC) curves. The samples used in this study are the remaining samples from the clinical laboratory. Results: CSF detection using Mindray LDH, ALB, and ADA biochemical reagents was performed, and the values of coefficient of variation (CV) were all less than 2%. LDH exhibited good linearity in the range of 0–1,267.99 U/L with a correlation coefficient (R2) of 0.9981. ALB exhibited good linearity in the range of 0–4,738.48 mg/L with an R2 of 0.9980. ADA exhibited good linearity in the range of 0–273.98 U/L with an R2 of 0.9999. In non-CNS diseases, the reference intervals for LDH and ALB in CSF were ≤25.072 U/L and ≤399.94 mg/L, respectively, while in non-tuberculous meningitis (non-TM), that for ADA in CSF was ≤3.32 U/L. Compared with the reference measurement procedure (using UV spectrophotometry), the regression equations for Mindray LDH, ALB, and ADA biochemical reagents were y = 0.9869x − 1.3422, y = 0.9694x + 9.4944, and y = 1.0243x − 0.1348, respectively, and the R values were 0.9986, 0.9989, and 0.9968, respectively. In the aided diagnosis of CNS diseases, the area under the curve (AUC) values of LDH and ALB in CSF were 0.782 and 0.798, respectively. When used to differentiate between TM and non-TM, the AUC value of ADA was 0.935. Conclusions: The analytical performance of Mindray biochemical reagents in detecting LDH, ALB, and ADA in CSF in the laboratory is acceptable. These reagents could be used in daily clinical detection and provide precise results for clinical practice.