F S 34 V E N T U R R U M E S T Coagulation Analyzers(Point .

IN SUS RVTR EU YM OE FNTS34 / CAP TODAYAugust 2003Coagulation Analyzers (Point-of-care, self-monitoring)Coagulation device makers giving users what they needIAnne Fordf necessity is the mother of invention, desperation is its father. Askthe staff of any emergency department, in which the frequently frenzied pace is making more and moredemands on point-of-care testing.“There aren't many clinicians thatwant to run diagnostics in their OR,CCU, ED, etc.,” says Michael Corsello, Abbott point of care senior marketing manager. “Instead, many ofthese clinicians feel that they haveto run these diagnostics to keep inpace with the throughput and therapy regimens assigned to critical patients.” That puts all the more pressure on point-of-care coagulation analyzer manufacturers to offer products that, Corsello says, help thephysician “aggressively manage thetherapy of the patient in the unit.”The manufacturers of the point-ofcare coagulation analyzers profiled inthis month's instrumentation survey, on pages 35–42, aim to do justthat with forthcoming or recentlyintroduced products and features.Not to be outdone, the manufactur-ers of self-monitoring coagulationanalyzers featured in the survey arestepping up to the plate as well.Instrumentation Laboratorylaunched in November 2003 its GEMPCL Plus Coagulation Laboratory, aportable whole-blood coagulationsystem that can be used in point-ofcare settings as a standalone systemor in conjunction with IL's GEM Premier 3000 Critical Care analyzer. TheGEM PCL Plus, says product manager Elizabeth Walsh, “is easy to use,maintenance-free, and offers fully automated sample measuring and mixing.” The instrument's security features include a compulsory operator/patient identification functionand QC lockout. Other new instruments on the market include HelenaLaboratories' Actalyke XL activatedclotting time test system, which features dual test wells, two-point clotdetection, and battery backup forportability; and Medtronic's ACTPlus, which features a bar-code scanner and a data-management program.Both Roche and Abbott haveadded or will soon add capabilitiesto their existing analyzers. Rocheplans to launch a new PT-S test stripfor use with the company's CoaguChek S analyzer. The new stripwill feature simplified liquid controls, insensitivity to heparin or lowmolecular-weight heparin, and anISI of 1.0 (human recombinant tissuefactor). “In addition to these newfeatures,” says Roche CoaguChekSystems manager Randy Pritchard,“it will continue to offer all the benefits of the current PT strip.” Meanwhile, Abbott Point of Care hasadded a kaolin activated clottingtime test to its point-of-care i-Statsystem. Says Corsello: “Simply usethe desired unitized test cartridge,add two drops of blood, and youcan have the results in minutes atthe patient bedside.” Over the next18 months, the company plans toexpand the i-Stat's menu with parameters such as CK-MB, BNP, andAPTT. New capabilities are on thehorizon as well for an InternationalTechnidyne coagulation system thathas onboard controls, says marketingmanager Kathy Kornafel: “We anticipate continued improvements tothe ProTime system in response tocustomer feedback in the very nearfuture.”Several trends in POC and selfmonitoring coagulation analyzersare emerging, say many manufacturers. HemoSense has been in thecoag analyzer market for only a shorttime, notes executive vice presidentof sales and marketing Timothy Still,but he's learned already that onboard quality controls “are a majordifferentiating factor for doctors andpatients.” He adds, “HemoSense currently offers onboard QC with everytest strip.” And what about self-monitoring analyzers? International Technidyne's Kathy Kornafel sees nothingbut growth in that area. “With patients taking a more active role intheir health, self-monitoring at homeis in demand,” she says.CAP TODAY's survey of pointof-care and self-monitoring coagulation analyzers includes productsfrom the man

Both Roche and Abbott have added or will soon add capabilities to their existing analyzers. Roche plans to launch a new PT-S test strip for use with the company's Co-aguChek S analyzer. The new strip will feature simplified liquid con-trols, insensitivity to heparin or low-molecular-weight