LAB-Net completes pilot sample analysis for POS-ARI-ER study

POS-ARI-ER tackles pathogens with proven epidemic potential, such as influenza viruses and coronaviruses. The study’s primary research objective is to compare the effectiveness of different diagnostic and therapeutic practices for acute respiratory infections (ARI). It also provides descriptive analyses related to patient characteristics, complications, outcome and risk factors. In the long-term, the study aims to develop an infrastructure capable of rapidly implementing randomised controlled trials and other clinical studies related to the diagnosis and treatment of ARI. 

LAB-Net has been actively contributing to this ECRAID-Base study since April 2023. During the study’s setup, a manual was created for correct sampling and management of the nose and throat swabs and trained all relevant staff of the involved laboratories. Furthermore, LAB-Net made sure that all sample kits were sent to the labs. These steps are important to ensure uniform, high-quality samples that can be compared over time across the different countries.

First sample quality checks 

In December 2023, LAB-Net organised pilot shipments of 41 combined nose-throat swab samples (collected between June and December 2023) from three UK-sites to be sent to the central laboratory in Antwerp, in order to check the correct use of the provided labels. 

To ensure samples can be reconciled with each participant, it is important that all samples are labelled correctly and that their related data are available in Castor, the electronic data capture (EDC) system. After completing checks for the samples collected as part of this pilot, it was concluded that all samples had been labelled correctly and all laboratories passed the necessary quality check. This validates the effectiveness of the existing training, training materials and process.

Next steps

Now that LAB-Net has piloted the sample shipment and analysis pipeline, the team will proceed to arrange shipments for samples across all sites, to be analysed for the study’s first interim analysis, including samples collected up until the 30th of April 2024. LAB-Net will continue to train and support all laboratories involved in the POS-ARI-ER study, as well as providing the sample materials and all required manuals. 

The overall recruitment target is to enroll up to 11,750 participants, with up to ~2900 participants undergoing baseline upper respiratory tract research sampling, over a period of 3,5 years. During this part of the year, LAB-Net expects that recruitment may slow, resulting in a smaller number of samples, but in the winter, the team anticipates an uptick once again, with a commensurate increase in numbers of samples.

POS-ARI-ER practical setup

The patient population of POS-ARI-ER includes adults (≥ 18 years old) that enter the ER with clinical suspicion of a new episode of an acute respiratory tract infection (with onset in the last 10 days presenting to an ER or secondary care setting). Patients transferred from another hospital or admitted to the hospital for >2 days at time of enrolment or patients previously enrolled in the POS-ARI-ER study will be excluded from participation. 

A subset of participants (approximately 25% of 11 500 over the course of over 3.5 years) will have a single combined nose throat swab (NTS), obtained at baseline (within 24 hours of enrolment), for pathogen detection by molecular methods.