Application properties and biosafety enhancement in saliva collection: optimization of a non-blowing medical device

Background Saliva stands out among diverse biological samples, offering readily available DNA samples through non-invasive collection methods. This open sampling method, which uses repetitive blowing actions for saliva collection with increased safety risks, poses a matter of concern. Methods By employing the non-blowing method, this study designed a closed-chamber medical device for saliva collection. Compared with repetitive collection in commercial devices (Class I medical devices), its sampling efficiency was assessed with quantitative saliva. After being stored in this device for six months, DNA was extracted and amplified integrating PCR with high-resolution melt (HRM) via a detection kit. Twelve-month saliva samples underwent a limit test under the minimum limit DNA template. The applications for concordance among paired blood–saliva samples was further assessed in microarrays. Results Non-blowing saliva collection offered closed-chamber biosecurity and its collection efficiency was comparable to that of commercial devices (Z = -0.778, P = 0.477). After six months of storage at room temperature, DNA extraction and quantification of saliva showed that DNA yield from the non-blowing saliva collection was also comparable to that of the commercial device (Z = -1.886, P = 0.064). Six- and 12-month saliva samples stored in this non-blowing device solution at room temperature maintained a reliable DNA quantity and quality for HRM, comparable to those of commercial devices with repetitive blowing-type. In the limit test, PCR-HRM demonstrated that stable extracted-DNA was successfully genotyped, and the peaks-valleys also tended to be consistent between the two devices. For paired blood–saliva samples, quality-control parameters in microarrays were within the feasible quality limits. Conclusions Non-blowing type saliva collection device has good application performance in both PCR-HRM and microarray. This study presents a new medical device designed to provide healthcare professionals with a biosecure and practical solution for saliva sample acquisition.