Manufacture Optimization And Functional Studies Of New Latex Agglutination Ovulation Diagnoistic Products

Immunoassay is the key technology for in-vitro instant diagnosis ofovulation. Antibody and antigen are used for semi-quantitative orqualitative inspection in immunoassay. The basic principle is the specificresponse between antibody and relevant antigen.The purposes of this research is increasing the manufacturingefficiency and reducing the cost of material and human resources byimproving NC and latex spraying procedures with automatic machines.At the same time, the new ovulation diagnostics ought to be functional,accurate, economical and stable. Furthermore, the snout of ovulationdevice should be strictly controlled to avoid abnormal results caused byflooding or overflowing defects.The introduction of NC automatic dispensing machine and latexautomatic spraying machine result in approximately120%increase onproduction efficiency and about150%decrease on human resourceduring manufacture. Both automatic machines have on-line inspectionsystems to mark black dots on defect strips by the camera detection. Theonline inspection system avoids defect strips, which improves the yieldand efficiency of the new ovulation diagnostics.Ovulation diagnostics, manufactured with optimizing procedures byintroducing automatic machines, show comparable or better performances than previous ovulation products through various tests including function,interference, cross reaction, and acceleration stability at50degreescentigrade.Moreover, the performance and quality of the new ovulationdiagnostics was improved by adjusting snout height of the devices to therange of4.33-4.43mm, which resulted in possibly lessflooding/overflowing defects. The flooding/overflowing defects maypotentially lead to false-positive, false-negative, or even no results.Therefore, there will be less customer complaining on abnormal resultsafter using ovulation diagnostics. The function, sensitivity,negative/positive results and specificity are excellent through strictlycontrolling products snout through relevant validation tests. The snoutcontrol method could greatly reduce the defect proportion. The snoutcontrol measure provided relevant validation data and experiences for theovulation diagnostics. It should be massive introduced into productsmanufacture process.High efficiency, high quality and low production cost are achievedthrough introducing automatic machines into optimizing ovulationdiagnostics spraying procedures. The device snouts control method isconsidered to be effective and practical during validation. Abnormalrunning performance could be prevented from strictly controlling snoutsof ovulation devices, which paved the way for the massive device production in the future.