Volume 45, Issue 4-5

Blood gas analysis at or near the patient’s bedside is a common practice in acute medicine and plays a crucial role in the diagnosis and management of patient’s respiratory status, metabolites, electrolytes, co-oximetry and acid–base balance. Pre-analytical quality aspects of the specimens are getting more and more attention, including the presence of potential interferences. Central laboratories have implemented technologies to detect interferences such as hemolysis, lipidemia or hyperbilirubinemia in blood samples to ensure the highest possible quality in results provided to routine care. However, systematic detection for interference due to hemolysis is currently not in place for blood gas analysis at the point-of-care (POC). To apply hemolysis detection solutions at the central laboratory, but not at the POC for blood gas analysis, is a clear contradiction when novel hemolysis detecting technologies are available. The introduction of a system that systematically detects hemolysis in connection to POC blood gas analysis would be imperative to patient safety and costs associated with potential clinical malpractice (leading to wrong, missing and/or delayed treatment) and would also ensure better compliance to CLSI guidelines and ISO standards, and be beneficial for patient and staff.

Objectives Legal regulations and guidelines such as the Guidelines of the German Medical Association for the Quality Assurance of Laboratory Medical Examinations (Rili-BAEK) and ISO 15189 apply to electronic laboratory reports. However, many laboratories struggle with practical implementation of these regulations and guidelines. Methods Laboratory and legal experts analyse the relevant guidelines and provide checklists and practical recommendations for implementation. Results Laboratories have less control over the display of electronic laboratory reports than over paper documents. However, an electronic report alone is legally sufficient and need not be accompanied by a paper copy. Rili-BAEK and ISO 15189 stipulate a set of minimum information in every report. The laboratory must verify that reports are transmitted and displayed correctly. To help laboratories do so, agreements between laboratories and the report recipients can clarify responsibilities. Conclusions Electronic laboratory reports can improve patient care, but laboratories need to verify their quality. Towards this end, Rili-BAEK and ISO 15189 set out helpful provisions.

Objectives Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is rapidly spreading globally. Early diagnosis plays an essential role in controlling the infection. Therefore, early and accurate SARS-CoV-2 detection assays along with easy operation are required. The aim of this study was to compare the clinical performance of the Ampdirect™ 2019-nCoV Detection Kit (SHIMADZU assay), which does not require RNA purification steps, with that of the preexisting SARS-CoV-2 detection assays, which use a purified RNA template. Methods A total of 71 samples (65 nasopharyngeal specimens and 6 sputum specimens) were collected from 32 individuals, including patients infected with SARS-CoV-2 and those with suspected infection. The sensitivity and kappa ( κ ) coefficient were assessed between the SARS-CoV-2 detection assays using the reference standard, which was defined as a true positive result by any one of the four SARS-CoV-2 detection assays. Results The overall sensitivity and κ coefficient of the SHIMADZU assay were 86.0% (95% confidence interval [CI]: 77.9–94.2) and 0.83 (95% CI: 0.69–0.96), respectively. In particular, among the 18 samples collected within 10 days from symptom onset, the sensitivity and κ coefficient of the SHIMADZU assay were 100% and 1.0, respectively. Conclusions Although a relatively small number of samples was evaluated, the SHIMADZU assay showed good analytical performance and as such would be highly useful for the detection of SARS-CoV-2. The test can be performed easily and quickly and has the potential for future applications in situations where a highly sensitive diagnosis is required.

Objectives Accurate and rapid diagnosis of sexually transmitted infections (STIs) is essential for timely administration of appropriate treatment and reducing the spread of the disease. We examined the performance of the new Alinity m STI assay, a qualitative real-time multiplex PCR test for simultaneous identification of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Mycoplasma genitalium (MG), and Trichomonas vaginalis (TV) run on the fully automated Alinity m platform. Methods This international, multicenter study evaluated the accuracy, reproducibility, and clinical performance of the Alinity m STI assay compared to commonly used STI assays in a large series of patient samples encountered in clinical practice. Results The Alinity m STI assay identified accurately and precisely single and mixed pathogens from an analytical panel of specimens. The Alinity m STI assay demonstrated high overall agreement rates with comparator STI assays (99.6% for CT [n=2,127], 99.2% for NG [n=2,160], 97.1% for MG [n=491], and 99.4% for TV [n=313]). Conclusions The newly developed Alinity m STI assay accurately detects the 4 sexually transmitted target pathogens in various collection devices across clinically relevant specimen types, regardless of single or mixed infection status.

Objectives Pre-albumin (PAB) can be used to evaluate the association between nutrition status and in-hospital mortality. However, there is no literature to compare if PAB is the best indicator to predict in-hospital mortality among the nutrition indexes in a study. Methods We operated a retrospective study including 145 patients admitted to our institution’s elderly intensive care unit (ICU) from January, 2017 to December, 2019. Admission laboratory results were collected. Regression analysis and receiver operating curve (ROC) were analyzed to explore the performance of different nutrition indexes. Results The levels of PAB were significantly different between the survivor and non-survivor group (p=0.001). Univariate analysis showed nutrition indexes (lymphocytes, albumin, body mass index [BMI], geriatric nutritional risk index (GNRI), prognostic nutritional index [PNI] and PAB) were associated with in-hospital mortality (all p<0.1). Following adjustment for age, platelets and creatinine (CREA), only BMI and PAB remained statistically significant (BMI: HR 2.799, 95% CI 1.167–6.715, p=0.021; PAB: HR 6.329, 95% CI 2.660–15.151, p<0.001). In addition, PAB had the highest area under the curve (AUC) for predicting in-hospital mortality (AUC = 0.696) followed by BMI (AUC = 0.561) and other factors. Conclusions PAB is a better predictor of in-hospital mortality than other nutrition indexes in elderly ICU patients.

Objectives The aim of this study is to investigate the status of laboratory practice of organic acid (OA) analysis using gas chromatography–mass spectrometry in China. Methods A survey, investigating details of laboratory practice of OA analysis, was issued on the website of the National Center for Clinical Laboratories of China. Nationwide external quality assessment participating laboratories of OA assay were informed to participate in this survey. Results A total of 36 laboratories completed this survey. Most laboratories started OA analysis during 2016–2020. Most (100%) labs reported semi-quantitative results, in which 79.4% of labs adopted the form of the ratio of peak area of OA and quantitative internal standard. Rare labs reported quantitative results. Few labs released reports in three days, most in 5–7 days. The source of control materials varied, 64.5% of labs adapted self-made materials. A total of 43.8% of laboratories directly used reference intervals (RIs) from published literature, 43.8% of laboratories established RIs themselves, but 21.2% of laboratories reported they didn’t verify RIs. Conclusions Appropriate supervision for the organic acid assay is needed in the aspect of the turnaround time of reporting results, the establishment validation and verification of reference ranges, and the quantification of results.

Objectives The following report describes the development and implementation of a small-lab automation solution for small hospitals. Methods It uses a new generation of collaborative robots instead of the traditional laboratory automation lines with their input and output units and connected analyzers. After the Proof of Concept during fall 2018, both a centrifuge and several routine analyzers were integrated. Results The run-up phase ended after successful test operations in continuous mode in 2019. Routine operations were launched in October 2020 in a MVZ routine lab after a delay caused by the pandemic. Conclusions Apart from the direct cost savings for night duty or compensation for the lack of personnel, the mentioned solution delivers a significant upgrading of the laboratory technicians’ activities and an improvement in their working conditions.