8 MINUTES TO BETTER HIV/AIDS PATIENT CARE
Contents
1. ss PointCare FAN NOW System 8 MINUTES TO BETTER HIV AIDS PATIENT CARE CD4 CD4 HEMATOLOGY ONE SAMPLE ONE SYSTEM ONE VISIT IMPROVE HIV AIDS PATIENT CARE IN 8 MINUTES Imagine the power of knowing in just eight minutes and in one easy report 12 results critical to better disease management CD4 CD4 and selected hematology parameters The FDA cleared PointCare NOW system with flexible power options lets you test anywhere anytime enabling fast easy set up for clinic and mobile use We supply all you need for testing in one box from reagents controls and phlebotomy supplies to barcoded patient ID labels and printer paper Unlike traditional instruments the PointCare NOW system requires minimal training to operate And there is no need for cold chain transport refrigeration or protection from bright lights or extremes of temperature for reagents all logistical obstacles are gone ONE SAMPLE ONE SYSTEM ONE VISIT IT S EASY 1 Draw 2 Test a 3 Take Clinical Action NOW 0 8 Minutes All phlebotomy supplies included Scan sample ID with barcode reader Read 12 results in one Simply drop in sealed reagent vials amp simple report printed amp stored capped blood sample gt Reduce loss to follow up WALK AWAY Capped blood sample tube Automated software interprets raw data No exposure risk a ddwy 4 5 Ne He No subjective interpretation of dot plots No manual steps 8 0002. 3 CD4NOW LiquiPacks Containing diluent lysing reagent and cleaning solution for 100 tests 1 CDANOW Gold Pack Containing colloidal gold reagent for CD4 labeling for 100 tests Dally Check Controls 3 tubes each of Low and Normal levels All phlebotomy supplies Tourniquets needles needle holders gloves blood collection tubes alcohol swabs gauze pads gt All other necessary supplies Barcoded patient ID labels waste tablets printer paper and ribbon Note No cold chain or refrigeration required Reagents amp controls are not light sensitive Shelf Life Reagents 12 months from date of manufacture when stored at 2 to 30 C 36 to 86 F Transient exposure shipping delay or temperature excursion of 10 days at 50 C 122 F Daily Check Controls months from date of manufacture when stored at 2 to 42 C 36 to 108 F Transient exposure shipping delay or temperature excursion of 10 days at 50 C 122 F Quality Control Information Internal 53 check points monitored and recorded on every sample External Daily Check Low and Normal levels run once a day Validation results available upon request Levey Jennings plots generated automatically Log for QC data recorded as mean SD and CV Additional hematology and CD4 external controls available in two levels System Operation Ease of Use Fully automated No manual steps for pipetting incubation vortexing etc
3. 8 hours from time of draw gt Hemoglobin concentration gt Lymphocyte count amp percent gt Neutrophil count amp percent gt Monocyte count amp percent gt Eosinophil count amp percent Specifications Time to result 8 minutes for all results gt Throughput 50 samples per day Batch size One samples are run individually PRECISION amp REPORTABLE RANGES PARAMETER REPORTABLE RANGE PRECISION LEVEL CD4 Count 50 to 6000 cells uL 600 uL 10 l00to200 uL lt 15 CD4 Percent 30t0770 wec 05 to 400 W L 60107 uL lt 3 Hemoglobin 1 0 to 20 0 g dL 12 g dL lt 2 Lymphocyte Count 02t0150 2010 uL lt 5 Lymphocyte Percent 120 to 800 Neutrophil Count 0210235 W L 20107 uL lt 3 Neutrophil Percent 120 to 80 0 Monocyte Count 00t059 l0 uL 10107uL lt 7 Monocyte Percent 15 to 203 Eosinophil Count 00to58 W L 0310 uL lt 15 Eosinophil Percent 0 6 to 600 Determined by CD4NOW Control Low LINEARITY amp CARRYOVER PARAMETER PEARSONR CARRYOVER WBC 01 to 42 3 Hemoglobin 0 0 to 183 0 999 0 5 System linearity for all other parameters traceable to WBC system carryover below threshold for all other parameters REAGENT KIT INFORMATION Test Kit Consumables PointCare NOW Reagent Kit 100 contains all reagents controls and supplies needed for 100 tests
4. PICTURE the PointCare NOW system delivers on the spot results before the patient leaves the clinic CD4 CD4 HEMATOLOGY TESTING BETTER CLINICAL DECISIONS Loss to follow up has consequences far greater than the health of the individual patient It wastes precious resources and exacerbates the HIV AIDS crisis increasing the chance of drug resistant strains of infection and hampering efforts to reduce mother to child transmission of HIV However there is a simple cost effective way to reduce loss to follow up and improve health outcomes the Point Care NOW system No more logistical headaches sending samples to an off site lab No more waiting days or weeks only to find that the blood sample is damaged the patient is impossible to locate or she is too sick to return to the clinic With one sample one system one visit and in just eight minutes the PointCare NOW system gives you the essential information you need to make clinical decisions The system performs all data analysis automati cally theres no manual gating or interpretation of data required There is much more to proper management of HIVAAIDS patients than a regular evaluation of T cell status It requires assessment diagnosis and treatment of underlying health conditions That s why the PointCare NOW system delivers 12 results total in one easy report CD4 CD4 WBC Hemoglobin Lymphocyte neutrophil monocyte eosinophil coun
5. gt Barcode reader amp labels Simple sample tracking and reagent management Factory calibrated Low power consumption LED no laser no gain adjustments or color compensation required Instrument Software gt Data storage 000 onboard patient records unlimited patient records transferable to USB Automated data analysis No manual gating or data interpretation Menu languages English French Spanish Portuguese and Indonesian in development User Safety gt No exposure Closed tube sampling no exposure to contaminated blood Closed waste handling All hazardous waste is contained and decontaminated for safe disposal CUSTOMER SUPPORT At PointCare we re proud of our record of quality performance and customer support We listened to users and designed everything the PointCare NOW instrument and kits ordering logistics service and support to make it easy for customers in resource limited locations When you purchase a PointCare NOW system you can count on us to help you be successful On site installation services and user training come standard And help is just a phone call or e mail away Our typical response time is within one business day Our field service staff members are strategically located around the globe to support our customers Call customer support at 1 800 346 6906 or from outside North America 1 508 281 6925 E mail customersupport pointcare net WE RE A M
6. results stored on board USB port to transfer results Ready to use reagents USB flash drive included NOW SYST Proven field tes d technology Introduced in 2007 busy clinics around the globe including the largest HIV AIDS programs use the FDA cleared PointCare NOW system Comprehensive results in just 8 minutes CD4 604 and hematology parameters including white blood count WBC lymphocyte neutrophil monocyte eosinophil and hemoglobin Walk away sample in results out automation There are no manual steps required and it s easy to operate after only minimal training The ultimate in user safety This fully enclosed automated system with closed cap sampling offers significant biosafety features over other available CD4 systems No hoods Heat stable reagents amp Daily Check controls Eliminate the considerable hidden costs of cold chain shipping and refrigerated storage No light sensitivity Rugged system with flexible power Battery and solar option and fast easy set up for mobile use Operational for patient testing 20 minutes after transport Easy logistics amp supply chain with all you need for testing in one box All reagents Daily Check controls phlebotomy and other necessary supplies required to run 100 patient samples NO REFRIGERATION REQUIRED Serve More Patients Reduce Loss to Follow Up amp Improve Outcomes with the PointCare NOW System SEE THE WHOLE
7. ILE AWAY FROM THE RAINFOREST WHERE THERE ARE MOUNTAIN GORILLAS RIGHT ON THE BORDER BETWEEN UGANDA AND THE DEMOCRATIC REPUBLIC OF CONGO There aren t any tarmac roads here there isn t any public transport and lots of the patients live a day s walk from the hospital Many of them live a subsistence existence and they can t afford to get here So we drive to remote communities in our mobile HIV outreach clinic vehicle equipped with the PointCare NOW system and are up and running testing patients within 20 minutes of arrival Before we had this machine we d see somebody in the clinic then wed have to see them on another day to collect a blood sample We had a system of motorcycle riders that went round all of our outreach sites on a particular day to collect samples They would have to ride for four hours along a muddy road through the Impen etrable Forest to a laboratory on the other side where we could get them tested It took us three days to get the result and we couldn t get it back to the patient until we saw them again two weeks later Now with this simple piece of technology we can deal with problems immediately We re able to diagnose AIDS early manage it early and keep people living with HIV fit and well we ve been able to change HIV from being a death sentence into something that people can live with and lead productive lives Dr Paul Wil jams Bwindi Community Hospital Uganda THE POINTCARE NOW S
8. PointCare conducted an internal study to reevaluate precision for Low and Normal levels of CD4 Precision CV was 9 0 at the Low level and 4 9 at the Normal level when run 20 times each on two instruments SYSTEM INFORMATION Optional Accessories Customer Installation Package Portable travel case holds instrument printer With purchase of an instrument the following barcode reader power cords reagents etc is provided standard Portable battery pack lt The PointCare NOW instrument Folding solar panel pL NR Required Materials Not Provided USB flash drive PointCare Preventive maintenance kit Space Requirements User manual Instrument Printer Reusable waste container Heghtiscm Height 14 em On site installation amp operator training Width 25 em Width 16 em gt year limited warranty Depth 34em Depth 25cm Flexible Power Options Weight 12 kg Weight 27 kg Uninterruptible Power Supply UPS 110 V or 220 V Regulatory Status Portable battery power system gt FDA IVD cleared gt Solar charge system gt CLIA moderate complexity rating CE marked gt ISO 134852003 certified manufacturer lt UL listed ce SAMPLE amp RESULT SPECIFICATIONS Sample Information Results Provided Sample volume 40 pL whole blood gt CD4 absolute count amp percent Sample tube mL vacuum K2 EDTA blood collection tubes WBC O provided system also accepts 3 and 4 mL tubes Sample stability
9. YSTEM ADVANTAGE Absolute CD4 T Cell Count amp CDA Lymphocyte Neutrophil Monocyte Eosinophil Count and Parent for AIN Simultaneous Hematology CDA amp CDAY No Reagent Cod Chain or Refrigeration No Reagent Light Sensitivity Easy to Use with Only Minimal Training Fully Automated System No Manual Gating Required No Manual Pipetting Required Extensive Onboard Data Storage amp Management Closed and Decontaminated Waste Sytem Simple Low Power LED Light Source Low Energy Consumption Flexible Electrical Power attery Solar Option Anna ABOUT POINTCARE TECHNOLOGIES Our mission is to bring appropriate point ofcare diagnostics to resource limited settings We design manufacture and market our products to provide clinicians with the rapid results they need to improve patient care PointCare is a privately held FDA registered ISO certifi ed company Ordering information Description Part No PointCare NOW System Installation Package 8 includes instrument barcode reader USB flash drive preventive maintenance kit user manual reusable waste container on site installation amp operator training 1 year limited warranty PointCare NOW Reagent Kit 100 36000 contains all reagents controls and supplies needed for 100 tests Uninterruptible Power Supply 110 V 25052 Uninterruptible Power Supply 220 V 25054 Portable Battery Power System 25161 Solar Charge System 10214 To order obtain product
10. articles PointCare achieves a fast lt 1 minute antibody reaction time by adding a proprietary charge neutralizing reagent to the whole blood An axial light loss detector identifies any cell carrying the CD4 antigen on the basis of the granularity added by the colloidal gold label The system also employs a forward scatter detector in combina tion with the axial light loss detector to eliminate monocyte inter ference from the CD4 lymphocyte count and provide a differential count for four classes of white blood cells lymphocytes monocytes neutrophils and eosinophils The optical system uses a long lifetime LED light emitting diode light source LED light sources consume less power and tend to be more stable than the lasers used in traditional instruments enabling long service free operation Power consump tion for the total system is approximately 60 watts on average which is much lower than the multi kilowatt levels of power consumption encountered with laboratory flow cytometers The PointCare NOW system provides internal and external measures of quality control to ensure proper test performance for every sample Onboard controls automatically monitor and record more than 50 check points during every sample run When appropriate the system flags any abnormality that may require further clinical intervention from the laboratory or physician This eliminates errors by the operator in performing and reporting the test result and
11. e cap withdraws a precise aliquot of whole blood and biochemically processes the sample internally to give the results The door opens after eight minutes and the capped tube is returned to the user after the results are displayed on the instrument screen A printer comes standard with every system to generate a paper record of results Waste generated during the test is decontaminated automati cally and confined to a sealed container Users are not exposed to the biohazardous conditions encountered with standard methods of CD4 lymphocyte enumeration because operators do not remove the blood tube cap they do not pipette the sample and reagents into open tubes they do not vortex mix in an open tube and there are no contaminated reaction tubes and pipette tips for disposal The PointCare NOW system delivers 12 results in just eight minutes in one easy report that can be printed and stored It generates a white cell differential a total white cell count and a hemoglobin concentra tion measurement employing the same proven hematology technology used in reference labs The system also provides both absolute CD4 count and CD4 expressed as a percent of total lymphocytes This is achieved by using a label to change the natural light scatter character POINTCARE NOW CORRELATION SYSTEM SPECIFICATIONS istics of the CD4 subclass of lymphocytes to perform CD4 enumera tion The label consists of anti CD4 antibodies coupled to nano sized gold p
12. formation on the value of the CD4 CD4 and hematology parameters on the PointCare NOW system as well as references to relevant medical studies 5 FDA CLEARED POINTCARE NOW TECHNOLOGY The FDA cleared PointCare NOW system achieves its breakthrough performance in speed simplicity ease of use and stability because developers chose proven optical measurement techniques for its core technology and designed modular injection molded housings with few moving parts to create a robust instrument ideal for challenging environments and low resource settings The system has solid state electronics and comes pre calibrated from the factory eliminating the need for calibration by the operator The instrument platform combines two diagnostic systems in one rugged small footprint unit that the user operates like a hematology analyzer Its fluidics system prevents operator contact with blood blood or fluid aerosols and liquid waste therefore eliminating the costly need for a biosafety hood which is mandatory for traditional flow cytometry systems The operator takes a capped phlebotomy blood sample tube and with the cap still in place inserts the tube into a receiving slot in the instrument There are also two additional slots for reagent vials sufficient for 20 samples The instrument takes the tube inside automatically and the door closes and locks to prevent user interaction with fluids In a fully automated process the system pierces th
13. information or for any other inquires please contact Telephone 1 508 281 6925 Fax 1 508 281 6930 Headquarters USA PointCare Field Service amp Support PointCare Technologies Inc Regional Field Service Contacts 257 Simarano Drive Suite 101 Caribbean US based Senegal Marlborough MA 01752 USA Haiti South Africa Telephone 1 508 281 6925 Indonesia Tanzania Fax 1 508 281 6930 Malawi Thailand Efo Din Malaysia Uganda mail infoG pointcare ne Nigeria inia Our list of regional offices and distributors is growing Check our Web site for the latest contact details at www pointcare net www pointcare net contact or call 1 508 281 6925 Specifications subject to change without notice F 291 Rev C 2010 PointCare Technologies Inc ISO 13485 2003
14. reduces requirements of clinician time to troubleshoot and interpret inconclusive reports Data analysis software automatically identifies dot plot clusters for cell enumeration as well as abnormal clusters When abnormal clusters occur and accurate cell enumeration is compromised the software alerts the user via a screen message and does not report a result Operators are locked out of this software and cannot alter gates results or flag messages thus assuring the highest quality results at all times External Daily Check controls are included with test kits at no extra charge to ensure that the system pipettes pumps valves and optics are operating as specified Users should run Daily Check controls at the beginning of each workday before performing sample analysis CD4 Count System Hematology System 2007 POINTCARE NOW 510 K MULTI COUNTRY STUDY Samples 161 Sites 3 Pearson R 0 989 EPICS XL FACSCalibur amp AURICA Pearson R 0 956 to 0 994 Sysmex 2008 09 NATIONAL PUBLIC HEALTH LAB OF HAITI STUDY Samples 81 Sites 3 Pearson R 0 924 FACSCount Pearson R 0 975 to 0591 Sysmex WEC HGB NEU LYM EOS MON POINTCARE NOW PRECISION The 2008 09 study at the National Public Health Laboratory of Haiti ran a CD4 Low Control 20 times in order to evaluate repeatability The CD4 count precision CV from this study was 13 5 After the release of PointCare NOW System Version 2 in 2010
15. t and percent for all Is it time to initiate or change antiretroviral therapy Are there indicators of opportunistic infections or parasites The system s CD4 CD4 and hematology parameters give you greater insight into the patient s overall health on the spot before he leaves the clinic so you can follow up and treat accordingly POINTCARE NOW PARAMETERS FOR BETTER DISEASE MANAGEMENT 5 A 908 09 PointCare es White blood cell count NAME JOHN DOE Hemoglobin concentration can monitoring can help detect PID PR4478 SID PTO129123 help identify anemia early to opportunistic infection SEX MALE AGE YEARS 36 improve health outcomes BLOOD AGE HOURS 4 TUBE1 TESTEDON 08 09 11 20 SEQ CLINIC PCT USER JANE Low neutrophils put HIV AIDS ME GOLD KP82300004 LIQLI patients at increased risk for Rae as ag BC 67 HGBW 142 bacterial and fungal infection 8 t LYM 20 LYM Basics core a NEU 40 NEU 60 2 tuberculosis MON MON 4 604 is a critical parameter icd Cai mew in pes and adult care Eosinophils canbea coy mro pnm esce valuable marker to flag DETAILS increasing or decreasing lympho and monitor parasitic cyte population When viewed infection together CD4 CD4 and lym PRINT DONE phocyte can be a more accurate indicator of immune status than CD4 count alone facilitating internal cross checking of each CD4 patient report Visit www pointcare net publications for more in
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