How to verify and validate a clinical microbiology test before it can be used in routine diagnostics:a practical guide

Background: Before a new test can be routinely used in your laboratory, its reliability must be established in the laboratory where it will be used. International standards demand validation and verification procedures for new tests. The International Organization for Standardization (ISO) 15189 was recently updated, and the European Commission's In Vitro Diagnostic Regulation (IVDR) came into effect. These events will likely increase the need for validation and verification procedures. Objectives: This paper aims to provide practical guidance in validating or verifying microbiology tests, including antimicrobial susceptibility tests in a clinical microbiology laboratory. Sources: It summarizes and interprets certain parts of standards such as ISO 15189:2022, and regulations, such as IVDR 2017/746 regarding validation or verification of a new test in a routine clinical microbiology laboratory. Content: The reasons for choosing a new test and the outline of the validation and verification plan are discussed. Furthermore, the following topics are touched upon: the choice of reference standard, number of samples, testing procedures, how to solve the discrepancies between results from new test and reference standard, and acceptance criteria. Arguments for selecting certain parameters (such as reference standard and sample size) and examples are given. Implications: With the expected increase in validation and verification procedures because of the implementation of IVDR, this paper may aid in planning and executing these procedures.</p

Pengaruh Perceived Ease of Use, Perceived Enjoyment, Perceived Usefulness, dan Satisfaction terhadap Continued IT Usage Intention: Expected-Confirmation Model (ECM)

Fundraising activities digitally for various projects are growing in Indonesia, especially after the Covid-19 Pandemic appeared. The psychographics of the Indonesian people who are friendly have made them voluntarily donate to humanitarian activities. Kitabisa.com is one of the most popular crowdfunding platforms in Indonesia for online fundraising. The study’s purpose is to determine the Perceived Ease of Use, Perceived Enjoyment, Perceived Usefulness, and Satisfaction effect on Continued IT Usage Intention on the Kitabisa.com platform. 50 users of the Kitabisa.com platform were used to be a sample and taken using the saturation sampling technique or saturated sampling because of the suitability of the research characteristics. To analyze data, researchers conducted a path analysis using the Statistical Package for the Social Sciences (SPSS). Based on the study results, Perceived Ease of Use and Perceived Enjoyment significantly and directly affect satisfaction. In addition, satisfaction significantly influences the Continued IT Usage Intention. Meanwhile, only Perceived Usefulness significantly and indirectly affects the Continued IT Usage Intention through satisfaction. Furthermore, researchers also found that Perceived Ease of Use, Perceived Enjoyment, Perceived Usefulness, and Satisfaction were confirmed able to meet the expectations of users through the confirmation variable

Clinical outcomes of rifampicin combination therapy in implant-associated infections due to staphylococci and streptococci:A systematic review and meta-analysis

Objectives: Adjunctive rifampicin for implant-associated infections is controversial. This study investigated the clinical outcomes of rifampicin combination therapy compared with monotherapy in treating prosthetic joint infection (PJI) or prosthetic valve endocarditis (PVE) due to staphylococci and streptococci. Methods: A systematic search was performed from inception to 13 June 2022 in Embase, MEDLINE, Cochrane and Web of Science to investigate the clinical outcomes of rifampicin combination therapy compared with monotherapy in treating staphylococcal and streptococcal PJI or PVE. Randomised controlled trials (RCTs) and observational studies were included in the systematic review and meta-analysis. Results: Fourteen studies were included. A moderate quality of evidence was found in favour of rifampicin in patients with staphylococcal PJI who underwent a debridement, antibiotics and implant retention (DAIR) procedure [odds ratio = 2.49, 95% confidence interval (CI) 1.93–3.23]. Including the two RCTs only, adding rifampicin to the antibiotic regimen after DAIR was also in favour of rifampicin, but this was not statistically significant (risk ratio = 1.27, 95% CI 0.79–2.04; n = 126). Pooling data for patients with staphylococcal PJI who underwent a two-stage procedure showed that adding rifampicin was not associated with therapeutic success. Limited evidence was found for the use of rifampicin for PVE caused by staphylococci. Conclusions: Adding rifampicin in the treatment of staphylococcal PJI treated by DAIR clearly increased the likelihood for therapeutic success. The clinical benefit of adjunctive rifampicin in the treatment of other staphylococci and streptococci implant-associated infections is still unclear.</p

a case report

Background While most cases of polymicrobial vertebral osteomyelitis are secondary to hematogenous seeding, direct inoculation during spinal surgery and contiguous spread from adjacent soft tissue are also potential routes whereby pathogens may infect the spine. Case presentation A 74 year-old man presented with an exacerbation of back pain after a fall. His past medical history included hepatocellular and oesophageal carcinoma. Three months earlier he had undergone an endoscopic biopsy of the oesophagus for routine follow-up of his oesophagus carcinoma. He also underwent a vertebroplasty due to suspected pathologic fracture. On admission to hospital, magnetic resonance imaging revealed an infiltrative process at the level of the 5th and 6th thoracic vertebrae. Blood cultures were positive for both Streptococcus mitis and Gemella morbillorum. During his course of antibiotic therapy he developed an abscess at the level of 8th thoracic vertebrae and culture of this abscess grew Candida albicans. He was treated with antibiotics and antifungal drugs and recovered fully. Conclusion Vertebral osteomyelitis may be caused by direct spread following an oesophageal procedure. Microbiological diagnosis is essential to target the specific pathogen, especially in cases of polymicrobial infection

Polymicrobial vertebral osteomyelitis after oesophageal biopsy: a case report

BACKGROUND: While most cases of polymicrobial vertebral osteomyelitis are secondary to hematogenous seeding, direct inoculation during spinal surgery and contiguous spread from adjacent soft tissue are also potential routes whereby pathogens may infect the spine. CASE PRESENTATION: A 74 year-old man presented with an exacerbation of back pain after a fall. His past medical history included hepatocellular and oesophageal carcinoma. Three months earlier he had undergone an endoscopic biopsy of the oesophagus for routine follow-up of his oesophagus carcinoma. He also underwent a vertebroplasty due to suspected pathologic fracture. On admission to hospital, magnetic resonance imaging revealed an infiltrative process at the level of the 5th and 6th thoracic vertebrae. Blood cultures were positive for both Streptococcus mitis and Gemella morbillorum. During his course of antibiotic therapy he developed an abscess at the level of 8th thoracic vertebrae and culture of this abscess grew Candida albicans. He was treated with antibiotics and antifungal drugs and recovered fully. CONCLUSION: Vertebral osteomyelitis may be caused by direct spread following an oesophageal procedure. Microbiological diagnosis is essential to target the specific pathogen, especially in cases of polymicrobial infection

The unintended contribution of clinical microbiology laboratories to climate change and mitigation strategies:a combination of descriptive study, short survey, literature review and opinion

Objective: Climate change poses a significant threat to humanity and human activity is largely responsible for it. Clinical microbiology laboratories have their unintended shares in carbon dioxide (CO2) emissions. The aim of this study is to estimate CO2 emission of a clinical microbiology laboratory and to propose initiatives to reduce the emissions. Methods: CO2 emission of instruments was estimated based on their electricity consumption. CO2 emitted in producing consumables was estimated by weighing the consumables needed to perform major tests in a large academic hospital. A systematic literature review was performed to identify studies on the impact of clinical microbiology laboratories on the environment. A short survey was sent to four major manufacturers of agar plates on initiatives to reduce the environmental impact of their products. Opinion was given on activities that can reduce CO2 emission in laboratories. Results: The study shows that the largest amount of CO2 emission in the microbiological laboratories comes from consumables and personnel commuting. For example, the production and transportation of agar plates needed to culture samples for a year in a hospital with 1320 beds result in 16 590 kg CO2 is emitted. All survey participants mentioned that they were committed to reduce environmental impact of their products. The initiatives to reduce CO2 emission can be performed at the laboratory and at policy level, such as reducing the number of tests to only the necessary amount to reduce consumables. Discussion: The calculations contribute to map CO2-related emissions in clinical microbiology laboratory activities, and the proposed initiatives to reduce the CO2 may serve as starting point for further discussions