Effective Point of Use, Sterile NP Swabs
Origin has developed a direct-printed Nasopharyngeal Swab (NP Swab O1) for COVID-19 test kits. The swab is clinically effective, easy to use in the field and manufacturable at scale. All testing has shown that Origin swabs perform equally to standard swabs used for COVID-19 testing.
Origin’s NP Swab O1-S is an FDA-registered, Class I, 510(k) exempt device and produced following current good manufacturing practices (cGMP), 21 CFR part 820.
Now shipping individually packaged sterile (EO) NP swabs.
Clinically Validated and Peer Reviewed
Origin’s NP Swab O1 has completed a Phase III clinical trial and validation with Harvard’s BIDMC for expert evaluation, collection sufficiency, patient comfort, PCR/qPCR compatibility and benchmarks for mechanical performance testing including tensile and torsional tests.
Results have been peer reviewed and published on The Journal of Clinical Microbiology.
Overview
Flexible lattice, optimized for patient comfort & sample collection
Length: 155mm
Tip to breakpoint: 70mm
Handle diameter: 2.5mm
Tip diameter: 3.2mm
Tip to breakpoint: 70mm
Handle diameter: 2.5mm
Tip diameter: 3.2mm
Individually Packaged (Sterile)
ISO10993: Cytotoxicity, Irritation, Sensitization
Reverse Transcription-PCR & Real-time qPCR
Ethylene Oxide Gas (EO / ETO)
*0.89 Concordance (kappa) with Copan Control Swab (0.90)
Registered, Class I, 510(k) Exempt device
Origin is FDA-registered; devices are manufactured according to FDA Class I GMP guidelines