Trajan Neoteryx Mitra microsampling products

Trajan Scientific and Medical has announced the registration of its Neoteryx Mitra remote blood microsampling devices and Mitra Sample Collection Kits under a new manufacturing label.

The Mitra is registered with the TGA as a Class I in vitro diagnostic (IVD) medical device and the Mitra Kit is registered as a Class II medical device for home use. The updated regulatory compliance expands the use of the microsampling products in clinical settings, as well as home-based sample collection to support telehealth and personalised medicine. Doctors and research scientists seeking to boost clinical trial participation through remote sampling in rural communities, among non-traditional participants and patients with limited access to clinical sites can simply ship the sample collection kits to these populations for self-guided specimen collection.

Mitra is of benefit to clinical trial patients who fear needles or are inconvenienced by the requirements of a clinic-based blood draw. Following the instructions for use and a quick finger-stick, virtually anyone can use the device to collect a high-quality blood sample for lab testing. The patient or study participant uses the specimen bag and envelope provided in the home kit to send their samples to the lab. The microsamples integrate with laboratory analysis workflows, as shown in previous studies conducted by pharmaceutical companies, healthcare organisations and academic institutions around the world. As published in the literature, specimens collected with Mitra Kits have been used for detection of inflammatory biomarkers, PSA for prostate cancer screenings, antibodies against SARS-CoV-2 and more.

The microsampling solutions allow almost anyone to take an analytically viable sample in or out of a clinical setting, anytime, anywhere.