IVDT_In Vitro Diagnostics Technology

IVD Technology, Fall 2013

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TRENDS & PERSPECTIVES says Gaglani. "Many IVD devices are complicated or relatively inconvenient to use, which is why the smartphone provides a unique opportunity and has led to the mobilization of many of these devices." OraSure Technologies' OraQuick In-Home HIV test is the frst overthe-counter home-use rapid HIV test kit to detect the presence of antibodies to human immunodefciency virus type 1 (HIV-1) and type 2 (HIV-2). It is designed to allow individuals to collect an oral fuid sample by swabbing the upper and lower gums inside their mouths and placing that sample in a developer vial. Test results are obtained within 20 to 40 minutes. OraSure developed a fip-up laptop design for this test. By building the test stand into the actual box, the design "allowed for a more robust testing platform and enabled users to fip through step-by-step instructions as they conduct the test," write Lucy Sheldon, Karen Unterman, and Mick Withers in an MD+DI article on home-use IVDs (www.mddionline. com/article/vitro-diagnostic-testscome-out-lab-and-home). After Medicare approved home PT/INR use in 2009, new consumerized versions of PT/INR meters were designed to transmit data wirelessly to computers and, ultimately, physicians. Te resultant Alere INRatio2 device for anticoagulation management is small, unintimidating, and reminiscent of an iPod in its user interface. A fngerstick sample is placed on a test strip that performs both the test and the quality controls. Results are provided in about one minute. On the horizon, and possibly representing the future of molecular diagnostics, is an IVD device currently in development that acts as a smartphone-based PCR machine for point-of-care diagnostics. Te device, developed by start-up Biomeme, "turns your smartphone into a convenient, low-cost lab for quick DNA diagnostics and on-site disease tracking," according to Biomeme's website. Among its many potential benefts touted on the site are mobility, professional-caliber DNA lab diagnostics at low cost, connectivity, accuracy via qPCR, and ease of use. Writer Chris Velazco of TechCrunch.com describes the operation of the device this way. "Once you've connected your smartphone over Bluetooth, you slot it into the mobile PCR machine. Ten you crack open a test kit that detects diferent diseases . . . and do a bit of pipetting. After a bit of sample test prep, which co-founder and [business development] lead Max Perelman says even VCs have been unable to screw up—you load the sample into the top of the machine and wait for your results." —Maureen Kingsley Introducing micropoc... $BSDMPEJBHOPTUJDTPMVUJPOTJTBEJWJTJPOPG$BSDMPQMD XIJDICSJOHTUPHFUIFSNBOZZFBSTPGFYQFSJFODFJOUIF NBOVGBDUVSFPGEJTQPTBCMFJUFNTGPSUIFIFBMUIDBSF JOEVTUSZ NJDSPFMFDUSPOJDTFYQFSUJTF BOEEFWFMPQNFOUT JONJDSP¿VJEJDT SFBHFOUDIFNJTUSZBOETVSGBDF USFBUNFOUT8IBUJTNJDSPQPD© NJDSPQPDJTBTFMGSFBEJOH EJTQPTBCMF1PJOU0G$BSF EJBHOPTUJDTQMBUGPSNGFBUVSJOH BNFUFSFETBNQMFPGCPEZ¿VJE $-*"XBJWFQPUFOUJBM DPOUSPMMFESFBHFOUMPBEJOH BMPXDPTU¿VJETFOTJOHTZTUFNBOE BOPOCPBSETZTUFNUPEFUFSNJOFBOEEJTQMBZUIFUFTUPVUDPNF NJDSPQPDJTQPUFOUJBMMZEJTSVQUJWFUFDIOPMPHZ BEBQUBCMFUPB XJEFSBOHFPGBTTBZT NJDSPQPDSFNPWFTUIFOFFEGPSBTFQBSBUFJOTUSVNFOUBOE EJTQPTBCMFGPSFWFSZBTTBZUZQF BDMFBS MPXDPTUNBOVGBDUVSJOHSPVUFIBTCFFOJEFOUJ¾FE DETJTPGGFSJOHFYDMVTJWFMJDFOTJOHPQQPSUVOJUJFTJOSFUVSOGPS FYDMVTJWFNBOVGBDUVSJOHSJHIUT DETJTDVSSFOUMZEFWFMPQJOHUISFFEFWJDFGPSNBUTNJDSPQPDMJUF NJDSPQPD$"5BOENJDSPQPDQSP www.carclodiagnosticsolutions.com T: +44 (0)208 685 0500 8 IVD TEC HNOLO G Y | FA L L 2013 magenta cyan yellow black ES323616_IV1309_008.pgs 09.24.2013 02:21 UBM

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