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qLabs ® PT-INR Owren (Dry) Monitoring System for Professional Point of Care and Patient Self-Testing

qLabs PT-INR Owren (Dry) Monitoring System

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Page 1: qLabs PT-INR Owren (Dry) Monitoring System

qLabs® PT-INR Owren (Dry) Monitoring System

for Professional Point of Careand Patient Self-Testing

Page 2: qLabs PT-INR Owren (Dry) Monitoring System

qLabs® PT-INR Owren (Dry)Monitoring System

for Professional Point of Careand Patient Self-Testing

Micropoint Biotechnologies Co., Ltd.

6F, No. 3, Industry 5 Road

Shekou, Shenzhen, Guangdong

China, 518067

Tel: +86 755 86296766

Fax: +86 755 86673903

Email: [email protected]

www.micropointbio.com

ABOUT MICROPOINT

Micropoint Biotechnologies Co., Ltd. is a global provider of Point of Care Testing (POCT) systems and solutions. We are improv-ing patient care by providing rapid, accurate, reliable, and low cost diagnostic products. Micropoint’s patented microfluidic technologies and three proprietary POCT platforms enable testing at the same high quality level as a central lab, but with improved speed and convenience. Micropoint’s products are manufactured in cGMP and ISO 13485 certified facilities.

The qLabs® PT-INR Owren (Dry) test strip is CE marked. The qLabs® PT-INR tOwren (Dry) test strip is distributed outside of the US. For more information or to order the qLabs® PT-INR Owren (Dry) test strip, please email: [email protected].

P/N 701-00023 Rev. A1 2019-07

REF numberQS-2 Pro Professional 24 strips/box

Features • Individually wrapped test strips ensure integrity • Dry-reagent strips stored at room temperature for immediate use, no equilibration required • Strong correlation to central laboratory results • Built in communication port for a printer and connectivity software • LOW ISI as recommended by ACCP, CAP, and WHO • On-board internal quality control • Insensitive to variation in Factor V

Sample Types and Volume • Small fingertip blood sample 10 μL

Time to Results • Reliable PT-INR results in 30 -100 seconds

CV (%) • <5%

Hematocrit Range • 30% to 55%

Sensitivity to Heparin • Insensitive up to 1 U/mL blood (unfractionated & LMW) Heparin

Operating Temperature Range • 10° to 35° C

Operating Humidity Range • 10 % to 90 % RH

qLabs® PT-INR Owren (Dry) test strips show strong correlation with the ACL® TOP 500 CST PT-INR Owren test. The correla-tion coefficient is 0.98 with an intercept of 0.15 and slope of 0.94.

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