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
Original Article

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

Dubo Chen1#, Junyuan Huang2,3#, Yuting He1, Liangying Zhong1, Weiguo Lu2,3, Mario Plebani4, Pinning Feng1, Xilian Qiu1

1Department of Laboratory Medicine, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China; 2Department of Laboratory Medicine, The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Guangzhou, China; 3Guangdong Clinical Research Academy of Chinese Medicine, Guangzhou, China; 4Department of Laboratory Medicine, University Hospital of Padova, Padova, Italy

Contributions: (I) Conception and design: X Qiu; (II) Administrative support: P Feng; (III) Provision of study materials or patients: D Chen, J Huang; (IV) Collection and assembly of data: Y He; (V) Data analysis and interpretation: D Chen, J Huang; (VI) Manuscript writing: All authors; (VII) Final approval of manuscript: All authors.

#These authors contributed equally to this work.

Correspondence to: Xilian Qiu, BD; Pinning Feng, MD. Department of Laboratory Medicine, The First Affiliated Hospital of Sun Yat-sen University, No. 58 Zhongshan Er Road, Guangzhou 510080, China. Email: Qiuxlian3@mail.sysu.edu.cn; fengpn@sysu.edu.cn.

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.

Keywords: Cerebrospinal fluid (CSF); biochemical reagent; performance validation; diagnostic accuracy

Received: 02 August 2024; Accepted: 16 October 2024; Published online: 30 October 2024.

doi: 10.21037/jlpm-24-46

Highlight box

Key findings

• The lactate dehydrogenase (LDH), albumin (ALB), and adenosine deaminase (ADA) assays were validated for use in the Mindray BS-2800 analyzer for cerebrospinal fluid (CSF).

What is known and what is new?

• The results of the repeatability, linearity and methodological comparison of LDH, ALB, and ADA assays were excellent.

• The reference intervals of LDH, ALB and ADA for CSF were established.

What is the implication, and what should change now?

• Clinical laboratories should evaluate the performance characteristics of the biochemical assays for CSF.

Introduction

Lactate dehydrogenase (LDH) is extensively distributed in tissues, mainly including the heart, liver, muscles, and kidneys (1). Due to the blood-brain barrier (BBB), the concentration of LDH is lower in cerebrospinal fluid (CSF) than serum. Albumin (ALB) is the key component of plasma proteins with a small molecular weight. It is dominant among the proteins that enter CSF through the BBB ultrafiltration. Once the BBB is disrupted, LDH and ALB in CSF rise significantly. They can be used to assist in the diagnosis of central nervous system (CNS) diseases related to BBB damage, such as viral meningitis (2), bacterial meningitis (3,4), and meningeal tumors (5). Adenosine deaminase (ADA) catalyzes the deamination reaction of adenosine and degrades adenosine to hypoxanthine nucleoside, which is one of the primary enzymes in purine nucleoside degradation metabolism. An increase in ADA activity in CSF mainly occurs in tuberculous meningitis (TM). Therefore, ADA has supplementary diagnostic value for TM (6-10).

LDH, ALB and ADAs in CSF can assist the clinician in diagnosis (11,12). Consequently, CSF chemical testing is frequently requested by clinicians (13). Currently, most clinical laboratories use biochemical reagent produced by Roche, Beckman and Mindray to detect LDH, ALB and ADA in CSF. However, biochemical reagent manufacturers claim that the scope of application by LDH, ALB, and ADA includes serum/plasma samples but do not include CSF samples. Due to the heterogeneity of the CSF and serum/plasma matrices, the biochemical reagents suitable for serum/plasma may not necessarily be suitable for CSF (14-16). Relevant regulations for applying these biochemical reagents to CSF samples are insufficient, making it the responsibility of clinical laboratories to validate the analytical performance characteristics of these biochemical reagents when providing CSF testing for clinical use.

The Clinical and Laboratory Standards Institute (CLSI) and the College of American Pathologists (CAP) laboratory certification program both state that laboratories should evaluate and reasonably exclude the interference caused by humoral matrix effects to ensure that the detection methods applied to blood samples can also be applied to body fluids (17,18). The applicability of serum biochemical reagents in CSF detection has practical clinical significance and needs to be explored to obtain precise detection results for LDH, ALB, and ADA in CSF.

This study established a detection system with a Mindray chemistry analyzer (BS-2800M) and Mindray biochemical reagents for LDH, ALB, and ADA in CSF. The performance validation and reliability evaluation were conducted using the CSF detection system. Moreover, the accuracy of LDH and ALB in the auxiliary diagnosis of CNS diseases and that of ADA in the diagnosis of TM were assessed. We present this article in accordance with the STARD reporting checklist (available at https://jlpm.amegroups.com/article/view/10.21037/jlpm-24-46/rc).

Methods

Materials

Instruments and reagents

The biochemical analyzer employed was the BS-2800M chemistry-analyzer (Shenzhen Mindray Biomedical Electronics Co., Ltd., Shenzhen, China), and the reagents included LDH, ALB, and ADA biochemical reagent kits (Shenzhen Mindray Biomedical Electronics Co., Ltd.).

Samples

The CSF samples comprised residues from the Department of Laboratory Medicine of The First Affiliated Hospital of Sun Yat-sen University and the Department of Laboratory Medicine of The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine. Each sample was 1.5 mL without obvious precipitation or floccule. (I) Samples of non-inflammatory CNS diseases confirmed by physicians; (II) samples of convalescent CNS diseases validated by physicians; (III) samples of other diseases that do not affect BBB permeability. These three types of samples are used to construct the reference intervals of LDH and ALB in CSF. Samples from patients with non-tuberculous meningitis (non-TM) were used to establish the reference interval of ADA in CSF.

This study was approved by the Medical Ethics Committee of The First Affiliated Hospital of Sun Yat-sen University (No. 2024-069). The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine was informed and agreed with the study. The study was conducted in accordance with the Declaration of Helsinki (as revised in 2013). Informed consent was obtained from all the participants involved in the study.

Repeatability

A total of 20 CSF samples were collected for the replication experiments. Each sample was analyzed 10 times to calculate the average concentration and coefficient of variation (CV) (%). A scatter graph was plotted with the average concentration as the x-axis, and CV (%) as the y-axis.

Linearity

High-concentration samples close to or at the upper limit of the linear interval were considered high-value samples, and low-concentration samples near or at the lower limit of the linear interval were considered low-value samples to dilute high-value samples. The dilution ratios were recorded. At least nine concentrations were obtained, and the sample of each concentration was gauged twice. With the dilution degree as the independent variable (xi), and the mean of measurement (yi) as the dependent variable, the linear regression equation and its correlation coefficient (R2) were calculated (19).

Reference intervals

The non-parametric method was adopted to derive unilateral reference intervals according to the Approved Guideline EP28 Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory (Third Edition) (20).

Methodological comparison

The gathered CSF samples were detected twice using the Mindray fully automatic biochemical analyzer BS-2800M and reference measurement procedure (spectrophotometry), and the results for each variable were averaged. Next, a scatter diagram was drawn with the test results of the reference measurement procedure as the x-axis (X), and the results of Mindray BS-2800M as the y-axis (Y). Passing-Bablok linear regression was used to solve the regression equation (Y = kX + b) (21).

The target value (P0) of the total consistency rate is 95.00%, and the expected consistency rate (PT) is 99.90%. The sample volume was calculated by the formula:

n=[Z1−α/2P0(1−P0)+Z1−βPT(1−PT)]2(PT−P0)2

Diagnostic accuracy

CNS diseases that affect the permeability of the BBB were classified as positive, and those without this effect were classified as negative. Next, a receiver operating characteristic (ROC) curve analysis of LDH and ALB was performed. An ROC curve analysis of ADA was also conducted in which TM and non-TM were classified as positive and negative, respectively.

Statistical analysis

MedCalc v. 15.2.2.0 (Ostend, Belgium) and Microsoft Excel 2019 (Microsoft Corp., Redmond, WA, USA) were used in the statistical analysis. Passing-Bablok regression was used for the method comparison. A P value <0.05 indicated a statistically significant difference.

Results

Repeatability

The repeatability results showed that the CV (%) value of LDH in CSF (Figure 1A) was less than 2%, that of ALB in CSF (Figure 1B) was less than 1.2%, and that of ADA in CSF (Figure 1C) was less than 1.5%.

Figure 1 The repeatability of the biochemical CSF detection system using the BS-2800M fully automatic biochemical analyzer. (A) The CV of LDH in CSF. (B) The CV of ALB in CSF. (C) The CV of ADA in CSF. CV, coefficient of variation; CSF, cerebrospinal fluid; LDH, lactate dehydrogenase; ALB, albumin; ADA, adenosine deaminase.

Linearity

LDH, ALB, and ADA in CSF exhibited satisfactory linearity at both the high and low levels (Figure 2), of which the ranges were 0–1,267.99 U/L, 0–4,738.48 mg/L, and 0–273.98 U/L, respectively, and the R2 values were 0.9981, 0.9980, and 0.9999, respectively.

Figure 2 Linearity of LDH, ALB, and ADA in CSF. (A) LDH, (B) ALB, and (C) ADA. LDH, lactate dehydrogenase; ALB, albumin; ADA, adenosine deaminase; CSF, cerebrospinal fluid.

Reference intervals

In the aided diagnosis of CNS diseases that affect BBB permeability, the reference intervals of LDH (Figure 3A) and ALB (Figure 3B) in CSF were ≤25.072 U/L and ≤399.94 mg/L, respectively. When used to distinguish between TM and non-TM, the reference interval of ADA (Figure 3C) in CSF was ≤3.32 U/L.

Figure 3 Reference intervals of (A) LDH, (B) ALB, and (C) ADA in CSF. LDH, lactate dehydrogenase; ALB, albumin; ADA, adenosine deaminase; CSF, cerebrospinal fluid.

Methodological comparison

The concentrations of LDH, ALB, and ADA in the CSF samples were determined using the Mindray BS-2800M automatic biochemical analyzer with Mindray biochemical reagents. The detection results were compared using the reference measurement procedure [ultraviolet (UV) spectrophotometry]. The R values of LDH, ALB, and ADA were 0.9986, 0.9989, and 0.9968, and the regression equations were y = 0.9869x − 1.3422, y = 0.9694x + 9.4944, and y = 1.0243x − 0.1348, respectively (Figure 4A-4C).

Figure 4 The high consistency between the Mindray biochemical reagents and the reference measurement procedure (UV spectrophotometry). Passing-Bablok regression of (A) LDH, (B) ALB, and (C) ADA. LDH, lactate dehydrogenase; CI, confidence interval; ALB, albumin; ADA, adenosine deaminase; UV, ultraviolet.

Diagnostic accuracy

To investigate the efficacy of LDH and ALB in CSF in assisting in the diagnosis of CNS diseases that affect the BBB, this study statistically analyzed the levels of LDH and ALB in CNS and non-CNS diseases. In the control group, the mean concentrations of LDH and ALB in CSF were 15.63±16.61 U/L and 265.45±128.01 mg/L, respectively. Conversely, the mean concentrations of LDH (Figure 5A) and ALB (Figure 5B) in the CSF of patients with CNS diseases were significantly increased, being 132.65±231.46 U/L and 701.15±648.06 mg/L, respectively.

Figure 5 The levels of (A) LDH and (B) ALB in the CSF of patients with CNSDs and the levels of (C) ADA in the CSF of patients with TM. CNSD, central nervous system disease; LDH, lactate dehydrogenase; ALB, albumin; TM, tuberculous meningitis; ADA, adenosine deaminase; CSF, cerebrospinal fluid.

To explore the efficacy of ADA in CSF in assisting in the auxiliary diagnosis of TM, this study gauged the content of ADA in TM and non-TM. In the control group, the mean ADA was 0.98±0.91 U/L. Conversely, it was 4.89±3.83 U/L in the group of patients with TM, which represents a significant increase (Figure 5C).

This study further evaluated the diagnostic accuracy of LDH, ALB, and ADA using ROC curves. The specific parameters are shown in Table 1. The area under curve (AUC) value of LDH was 0.782. When the cut-off value was set to >25.13 U/L, the sensitivity was 64.9%, and the specificity was 91.1% (Figure 6A). The AUC value of ALB was 0.798, and with a cut-off value of >346.61 mg/L, the sensitivity and specificity were 66.7% and 83.9%, respectively (Figure 6B). The AUC value of ADA was 0.935, and with a cut-off value of >1.73 U/L, the sensitivity and specificity were 90.0% and 85.9%, respectively (Figure 6C).

Table 1

Parameters of the ROC analysis

Biochemical reagent Cut-off value AUC (95% CI) TP proportion (sensitivity) TN proportion (specificity) FP proportion FN proportion Youden’s index
LDH >25.13 U/L 0.782 (0.736–0.823) 0.649 0.911 0.089 0.351 0.560
ALB >346.61 mg/L 0.798 (0.743–0.846) 0.667 0.839 0.161 0.333 0.506
ADA >1.73 U/L 0.935 (0.884–0.968) 0.900 0.859 0.141 0.100 0.759

ROC, receiver operating characteristic; AUC, area under the curve; CI, confidence interval; TP, true positive; TN, true negative; FP, false positive; FN, false negative; LDH, lactate dehydrogenase; ALB, albumin; ADA, adenosine deaminase.

Figure 6 The ROC curves of (A) LDH and (B) ALB in the assisted diagnosis of CNS diseases, and (C) the ROC curves of ADA in the assisted diagnosis of TM. LDH, lactate dehydrogenase; ALB, albumin; ADA, adenosine deaminase; ROC, receiver operating characteristic; CNS, central nervous system; TM, tuberculous meningitis.

Discussion

CSF is a colorless and transparent fluid that pervades the ventricles, subarachnoid space, and central canal of the spinal cord. The CSF examination is usually divided into general trait identification and chemical detection. The chemical detection of CSF includes LDH, ALB, and ADA (22). An increase in LDH in CSF is common in: (I) cases of infection; (II) the acute phases of cerebral infarction, cerebral hemorrhage, and subarachnoid hemorrhage; (III) advanced brain tumors; and (IV) demyelinating disease. An increase in ALB in CSF mainly occurs in (I) brain tissue and meningeal inflammatory lesions; and (II) cerebral hemorrhage and brain trauma. Increases in LDH and ALB in CSF are related to the augmented permeability of the BBB. The elevation of ADA in CSF mostly appears in TM, and thus can aid in the diagnosis and differential diagnosis of TM. In clinical practice, current biochemical reagent kits are generally applied to detect the levels of LDH, ALB, and ADA in CSF. However, the suitability of these three biochemical reagents, which are produced by various manufacturers on the market, have not been evaluated for CSF samples. Therefore, clinical laboratories are responsible for evaluating and validating the analytical and clinical performances of these biochemical reagents for CSF sample detection before providing results for clinical work.

Through internal quality control, this study demonstrated that the detection system was in-control. The CSF samples were examined using a Mindray BS-2800M fully automatic biochemical analyzer with Mindray LDH, ALB, and ADA biochemical reagent kits. The repeatability test achieves satisfactory results. Only the two CV values of low-concentration LDH samples were greater than 1.5%, and those of the remaining samples were less than 1.5%. By preparing CSF samples of a series of concentrations (high and low), this study found that the linearity of LDH was as high as 1,267.99 U/L, that of ALB was as high as 4,738.48 mg/L, and that of ADA was as high as 273.98 U/L. The linearities of LDH, ALB and ADA cover the majority of clinical CSF samples and they can meet daily use requirements in the clinic.

According to EP28, the non-parametric method was adopted to establish the reference intervals for LDH, ALB, and ADA in CSF, which were ≤25.072 U/L, ≤399.94 mg/L, and ≤3.32 U/L, respectively. In the methodological comparisons, the Passing-Bablok regression demonstrated that there is a high correlation between the LDH, ALB, and ADA biochemical test kits and the reference measurement procedure (UV spectrophotometry). The diagnostic ability analysis verified the high efficacy of LDH and ALB in assisting in the diagnosis of CNS diseases that affect the BBB, and showed that ADA can be used in the auxiliary diagnosis of TM.

In summary, the Mindray LDH, ALB, and ADA biochemical reagents exhibited superior analytical performances in all potential clinical application scenarios of CSF. They could feasibly be used for daily detection in clinical laboratories and render accurate CSF test results for clinical application.

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.

Acknowledgments

Funding: None.

Footnote

Reporting Checklist: The authors have completed the STARD reporting checklist. Available at https://jlpm.amegroups.com/article/view/10.21037/jlpm-24-46/rc

Data Sharing Statement: Available at https://jlpm.amegroups.com/article/view/10.21037/jlpm-24-46/dss

Peer Review File: Available at https://jlpm.amegroups.com/article/view/10.21037/jlpm-24-46/prf

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://jlpm.amegroups.com/article/view/10.21037/jlpm-24-46/coif). M.P. serves as an unpaid editorial board member of Journal of Laboratory and Precision Medicine from May 2024 to April 2026. The other authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The study was conducted in accordance with the Declaration of Helsinki (as revised in 2013). This study was approved by the Medical Ethics Committee of The First Affiliated Hospital of Sun Yat-sen University (No. 2024-069). The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine was informed and agreed with the study. Informed consent was obtained from all the participants involved in the study.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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(English Language Editor: L. Huleatt)

doi: 10.21037/jlpm-24-46
Cite this article as: Chen D, Huang J, He Y, Zhong L, Lu W, Plebani M, Feng P, Qiu X. 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. J Lab Precis Med 2024;9:31.

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