title: Engineering a chemical implementation device and an imaging device for detecting chemiluminescence with a Polaroid high-speed detector film: application to influenza diagnostics with the ZstatFlu-II test.
abstract: We describe the engineering and product development of the chemiluminescent ZstatFlu-II Test kit for influenza diagnostics. The reaction vessel is a chemical implementation device with a polystyrene bottom chamber and a polypropylene top chamber that screw together. The patient's specimen is dispersed in a proprietary diluent and mixed inside the bottom chamber with the influenza viral neuraminidase-specific substrate, 1,2-dioxetane-4,7-dimethoxy-Neu5Ac. Neuraminidase catalysis releases the dioxetane. The top chamber contains 40% NaOH and is sealed at the top with an ABS plastic plug-crush pin assembly. The top chamber floor is 85% thinner at the centre, forming a frangible flap. An automated imaging device serves as an incubator for the chemical implementation devices and also facilitates the piercing of the flap by the crush pin. This action results in NaOH flushing into the bottom chamber, initiating chemiluminescence. The imaging device also exposes the Polaroid high-speed detector film to chemiluminescence. At the end of exposure, the film is automatically processed and ejected. Chemiluminescence from an influenza virus-positive specimen produces a "+"-shaped white image, archiving the diagnostic outcome. The modular ZstatFlu-II test kit components are easily adaptable for the chemiluminescent detection of a wide range of analytes.
authors.affiliation: QTL Biosystems, 2778 Agua Fria, Bldg. C Suite BC, Santa Fe, NM 87507, USA. achyuthan@qtlbio.com
authors.forename: Komandoor E
authors.initials: KE
authors.lastname: Achyuthan
authors.forename: Lisa M
authors.initials: LM
authors.lastname: Pence
authors.forename: Daniel R
authors.initials: DR
authors.lastname: Mantell
authors.forename: Paul E
authors.initials: PE
authors.lastname: Nangeroni
authors.forename: Donald M
authors.initials: DM
authors.lastname: Mauchan
authors.forename: William M
authors.initials: WM
authors.lastname: Aitken
authors.forename: James R
authors.initials: JR
authors.lastname: Appleman
authors.forename: Craig D
authors.initials: CD
authors.lastname: Shimasaki
mesh_terms: D001331:Automation; D004738:Engineering; D006801:Humans; D007091:Image Processing, Computer-Assisted / Q000379:methods*; D007202:Indicators and Reagents; D007251:Influenza, Human / Q000175:diagnosis*; D008163:Luminescent Measurements; D009439:Neuraminidase / Q000378:metabolism; D009975:Orthomyxoviridae / Q000201:enzymology; D010781:Photography; D010969:Plastics; D019095:Point-of-Care Systems; D011786:Quality Control; D011933:Reagent Kits, Diagnostic
chemical_list: D007202:Indicators and Reagents; D010969:Plastics; D011933:Reagent Kits, Diagnostic; D009439:Neuraminidase