Point of Care Diagnostic Tests

Transcription

1 Point of Care Diagnostic Tests / Canada

2 About BTNX Inc. Biotechnology Company BTNX Inc. is a world leader in rapid point-of-care diagnostics. We specialize in research, development and the manufacture of advanced in vitro diagnostic tests and information systems that manage clinical data for laboratories, clinics, hospitals and physicians offices. Our software solutions use HL7 and POCT1-A2 standards to securely deliver quick and accurate test results. Our Rapid Response products participate in external quality assurance programs from the American Association of Bioanalysts (AAB) and the College of American Pathologists (CAP). We receive unknown samples to run on our products for proficiency testing. Our results are then submitted for evaluation. Performance reports are received and recorded for quality management. BTNX Inc. products are manufactured in a facility whose management system is certified as being in conformity with ISO 9001:2008 and ISO 13485:2003 CMDCAS. BTNX Inc. provides its distributors with the highest quality products at competitive pricing. This is accomplished through partnering with the most innovative manufacturing facilities staffed with teams of expert professionals. In doing so, BTNX Inc. delivers real value to its customers. ISO 9001:2008 ISO 13485:2003 i BTNX Inc., 570 Hood Road Unit 23, Markham, Ontario, Canada, L3R 4G7 / Tel: / Fax:

3 Table of Contents Quick Pricing Guide Colorectal Cancer Screening 3-4 Fecal Immunochemical Test Urinalysis 5-6 Urinalysis Reagent Strips, Analyzers and Accessories Infectious Diseases 7 Strep A 8 H. pylori and Mono 9 Influenza A & B and Respiratory Syncytial Virus (RSV) 10 Adenovirus and Rotavirus Women s Health 11 Pregnancy 12 Ovulation and Menopause Glucose Monitoring 13 Blood Glucose Meter and Accessories Drugs of Abuse 14 Test Strips, Cassettes and Panels 15 Integrated and Split-Specimen Cups 16 Custom Combinations Alcohol 17 Breath, Saliva and ETG Urine Tests Accessories 18 Specimen Cups and Collection Accessories Contact Information 19 ii

4 Quick Pricing Guide Colorectal Cancer Screening FOB-9C36 Rapid Response Fecal Immunochemical Test (FIT) Kit Urinalysis U10.1-1S100 Rapid Response 10 Para (LEU, NIT, URO, PRO, ph, BLO, SG, KET, BIL, GLU) Urinalysis Reagent Test Strips U2.3-1S25 Rapid Response 2 Para Urinalysis Microalbumin/Creatinine 2 in 1 Combo Strips UA-U120 Rapid Response Urine Analyzer U120 Infectious Diseases STR-15S25 Rapid Response Strep A Test Kit HPY-13C15 Rapid Response H. pylori Test Kit MON-13C15 Rapid Response Mono Test Kit FLUAB-19C15 Rapid Response Influenza A&B Test Kit RSV-19C30 Rapid Response Respiratory Syncytial Virus (RSV) Test Kit Women s Health HCG-1C25 Rapid Response Urine Pregnancy Test Cassette - 20 miu Glucose Monitoring 04GLU-67NC Rapid Response Blood Glucose Meter (No Coding), 10 Lancets, AST Lancing Device, Sporty Carrying Case, Owners Manual, Warranty Card, Data Log Drugs of Abuse Multi-Drug Cup Multi-Drug Panel Misc. Drug 1

5 Quick Pricing Guide Additional Notes: 2

6 Colorectal Cancer Screening Fecal Immunochemical Test Higher compliance rate with patients 98% overall accuracy 50 ng/ml sensitivity No dietary restrictions No medicinal restrictions Specific for only Human Hemoglobin (hhgb) Product Code Product Description Format Qty/kit FOB-9C36 Rapid Response Fecal Immunochemical Test (FIT) Kit Cassette 36 FOB-9V30 Rapid Response - FIT - Buffer/Collection Tubes Tube 30 FOB-0M Rapid Response - FIT Mailers Mailer 50 Kit Contents 36 Test Cassettes 36 Buffer Tubes 1 Package Insert 3

7 Colon Cancer Screening Fecal Immunochemical Test When using the FIT for screening purposes use Z12.12 or Z When using the FIT as a diagnostic it can be used multiple times annually, has few limitations and is dictated by patient medical symptoms. ICD-10 Code Description Z12.12 Encounter for screening for malignant neoplasm of rectum Z12.11 Encounter for screening for malignant neoplasm of colon Z Personal history of other malignant neoplasm of large intestine Z80.0 Family history of malignant neoplasm of digestive organs D12.6 Benign neoplasm of colon, unspecified K92.1 Melena Black; black tarry feces that are associated with upper gastrointestinal bleeding R19.5 Other fecal abnormalities R19.7 Diarrhea, unspecified Hemoccult/Guaiac Card Rapid Response FIT 86% overall accuracy 98% overall accuracy Requires three stool samples on three separate days (300,000 ng/ml sensitivity) ColonCancerCheck on FIT Test: For those at average risk for colorectal cancer, a simple at home test the Fecal Occult Blood Test (FOBT) once every two years is recommended. ColonCancerCheck is Canada s first population-based, province-wide, organized screening program designed to raise screening rates and reduce deaths from colorectal cancer. Requires only one stool sample (50 ng/ml sensitivity) R19.8 Other specified symptoms and signs involving the digestive system and abdomen Patients must avoid: NSAIDs, red meat, Vitamin C, fruit juices, green vegetables No dietary or medical restrictions R10.9 Unspecified abdominal pain R10.84 Generalized abdominal pain Please contact BTNX Inc. at for a comprehensive listing of all ICD-10 codes. Mailers may require stool sample back to office Not specific to human hemoglobin Messy smearing of fecal sample Mailers require no fecal sample to office (only buffer tube) Reacts only to human hemoglobin Clean and easy sample collection 4

8 Urinalysis Urinalysis Reagent Test Strips U10.1-1S100 U10.1 strips most popular urinalysis screening Manufactured to the highest quality standards Each lot is checked with controls from three major manufacturers: Bio-Rad, Hycor and Quantimetrix Color chart on each bottle printed as an interpretive guide through a multi-layer printing process U-KET-1S100 Rapid Response 1 Para (KET) Urinalysis Reagent Test Strips Strip 100 U2.2-1S100 U5.1-1S100 U7.1-1S100 U10.1-1S100 URS-1S69 Rapid Response 2 Para (ph/sg) Urinalysis Reagent Test Strips Rapid Response 5 Para (LEU, BLO, NIT, PRO, GLU) Urinalysis Reagent Test Strips Rapid Response 7 Para (LEU, NIT, BLO, ph, PRO, KET, GLU) Urinalysis Reagent Test Strips Rapid Response 10 Para (LEU, NIT, URO, PRO, ph, BLO, SG, KET, BIL, GLU) Urinalysis Reagent Test Strips Rapid Response 11 Para Urinalysis Ultra Reagent Test Strips Strip 100 Strip 100 Strip 100 Strip 100 Strip 150 U2.3-1S25 Rapid Response 2 Para Urinalysis Microalbumin/ Creatinine 2 in 1 Combo Strips Strip 25 UTI-1S1 Rapid Response Urinary Tract Infection Test Strip Strip 3 Microalbumin/ Creatinine 2 in 1 Combo Strips U2.3-1S25 Screens for chronic kidney disease Accuracy: Microalbumin 91.9%, Creatinine 86% Rapid Response Urinary Tract Infection Test Strip UTI - 1S1 Detects leukocytes and nitrite in urine to aid in the screening of UTIs For diagnostic and OTC use 5

9 Urinalysis Urine Analyzers and Accessories Ask your local representative if you qualify for a free Rapid Response Urine Analyzer 60 seconds to results Compatible with Rapid Response 10 Para Urinalysis Reagent Test Strips Results are displayed on the screen and stored in memory after each test Analyzer stores results and prints reports without the need for special training Runs a self-test before each urine strip test, or each time power switch is turned on U500 features automatic calibration, self-test capability and LCD touch screen for UA-U120 easy use UA-U120 Rapid Response Urine Analyzer U120 Semi Automated 1 UA-U121 Rapid Response Urine Analyzer U120 with Barcode Reader Semi Automated 1 UA-U500 Rapid Response Urine Analyzer U500 Semi Automated 1 UA-U501 Rapid Response Urine Analyzer U500 with Barcode Reader Semi Automated 1 AUCT-1V1 Rapid Response Liquid Dip Tube Urine Controls Dip Tube 2 ADUCT-1S1 Rapid Response Dry Strip Urine Controls Strip 50 URS-VR-WB Rapid Response URS Visual Read Work Board Work Board 1 UA-U500 URS-VR-WS Rapid Response URS Work Sheets Sheets 100 6

10 Infectious Diseases Strep A 97% overall accuracy vs. culture (Gold Standard) Qualitative lateral flow immunoassay for detection of Strep A carbohydrate antigen in a throat swab No cross-reactivity with Streptococcus B, C, F or G Built-in procedural control STR-15S25 Rapid Response Strep A Test Kit Strip 25 STR-15C20 Rapid Response Strep A Test Cassettes Cassettes 20 Kit Contents 25 Test Strips 25 Disposable Extraction Test Tubes 25 Sterile Swabs 1 Reagent A 1 Reagent B 1 Positive Control 1 Negative Control 1 Procedure Card 1 Package Insert 1 Work Station 7

11 Infectious Diseases H. pylori and Mono Kit Contents 15 Test Cassettes 15 Droppers 15 Glass Capillary Tubes 1 Rubber Bulb 1 Buffer 1 Pair +ve/-ve Controls 1 Package Insert A rapid test for the qualitative detection of antibodies to Helicobacter pylori (H. pylori) Overall accuracy >99.9% Flexibility in testing whole blood, serum or plasma for antibody tests, or fecal for antigen tests HPY-13C15 HPY-9C20 Rapid Response H. pylori Antibody Test Kit Rapid Response H. pylori Antigen Test Cassette Cassette 15 Cassette 20 Kit Contents 15 Test Cassettes 15 Droppers 15 Glass Capillary Tubes 1 Rubber Bulb 1 Buffer 1 Pair +ve/-ve Controls 1 Package Insert A rapid test for the qualitative detection of infectious Mononucleosis heterophile antibodies Overall accuracy, sensitivity and specificity of 99% MON-13C15 Rapid Response Mono Test Kit Cassette 15 8

12 Infectious Diseases Influenza A & B and Respiratory Syncytial Virus Kit Contents 15 Flu A Test Cassettes 15 Flu B Test Cassettes 30 Extraction Tubes with Filter Caps 60 Disposable Pipettes 2 Buffers 1 Package Insert 1 Quick Reference Card A rapid test for the qualitative detection of Influenza A and Influenza B virus Flu A: Overall specificity >97%; Overall agreement >91% Flu B: Overall specificity >99%; Overall agreement >99% FLUAB-19C20 Rapid Response Influenza A&B Test Kit Cassette 15 *Contact BTNX for external controls Kit Contents 30 Test Cassettes 30 Extraction tubes with Filter Caps 30 Disposable Pipettes 2 Buffers 1 Package Insert 1 Quick Reference Card A rapid test for the qualitative detection of Respiratory Syncytial Virus antigen Positive agreement >98%; Negative agreement >99% vs. cell culture RSV-19C30 Rapid Response Respiratory Syncytial Virus (RSV) Test Kit Cassette 30 9

13 Infectious Diseases Adenovirus and Rotavirus Kit Contents 20 Test Cassettes 20 Droppers 20 Specimen Collection Tubes 1 Buffer 1 Package Insert A rapid test for the qualitative detection of various Adenovirus serotypes Overall sensitivity and specificity of >99% ADE-9C20 Rapid Response Adenovirus Test Kit Cassette 20 Kit Contents 20 Test Cassettes 20 Droppers 20 Specimen Collection Tubes 1 Buffer 1 Package Insert A rapid test for the qualitative detection of Rotavirus antigens Relative sensitivity >99%; Relative specificity >97% ROT-9C20 Rapid Response Rotavirus Test Kit Cassette 20 10

14 Women s Health Pregnancy Overall accuracy >99% For early detection of human chorionic gonadotropin in human urine Standardized with WHO international reference standard Sensitivity of 20 miu/ml - detects pregnancy as early as 7 days after conception 100% specificity - no cross reaction with FSH, LH or TSH HCG-1S50 Rapid Response Urine Pregnancy Test Strip - 20 miu Strip 50 HCG-3S50-20 Rapid Response Urine Pregnancy Combo(Urine/Serum) Test Strip - 20 miu Strip 50 HCG-1C25 Rapid Response Urine Pregnancy Test Cassette - 20 miu Cassette 25 Strip HCG-1C50 Rapid Response Urine Pregnancy Test Cassette - 20 miu Cassette 50 HCG-3C25 Rapid Response Pregnancy Combo(Urine/Serum) Test Cassette Cassette 25 HCG-3C50 Rapid Response Pregnancy Combo(Urine/Serum) Test Cassette Cassette 50 Cassette Midstream HCG-1C Rapid Response Urine Pregnancy Test Cassette miu Cassette 25 HCG-1M1 Rapid Response hcg Pregnancy Midstream Test Cassette - 20 miu Midstream 1 HCG-1C20NP Rapid Response Pregnancy Control Solutions - 20 miu Vials 1 HCG-1C2000NP-1 Rapid Response hcg Low Sensitivity Pregnancy Control Solutions miu Vials 1 11

15 Women s Health Ovulation and Menopause A rapid test for the qualitative presumptive detection of Luteinizing Hormone Overall accuracy of 98.7% with 30 miu cut-off 100% specificity - no cross reaction with FSH or TSH LH-1C25 Rapid Response Urine Ovulation 20 miu LH Test Cassette Cassette 25 LH-1C50 Rapid Response Urine Ovulation 20 miu LH Test Cassette Cassette 50 LH-1S50 Rapid Response Urine Ovulation 30 miu LH Test Strip Strip 50 LH-1M1 Rapid Response Urine Ovulation 30 miu LH Midstream Test Midstream 15 A rapid test for the qualitative detection of Follicle Stimulating Hormone (FSH) in urine Overall accuracy of 99% 100% specificity - no cross reaction with LH or TSH Sensitivity of 25 miu/ml FSH-1C25 Rapid Response Menopause 25 miu FSH Test Cassette Cassette 25 FSH-1C50 Rapid Response Menopause 25 miu FSH Test Cassette Cassette 50 12

16 Glucose Monitoring Blood Glucose Meter and Accessories High, Low & Normal Controls For OTC use Large LCD display 7-second reaction time Indicates ketone warning Single button operation Requires only 0.7μL blood Contains strip ejector 04GLU-67NC Rapid Response Blood Glucose Meter (No Coding), 10 Lancets, AST Lancing Device, Sporty Carrying Case, Owners Manual, Warranty Card, Data Log Meter 1 Lancing Device Sterile Lancets 04GLU GLU-69-NC Rapid Response Blood Glucose Meter Evaluation Pack, H+L Controls, 10 Strips and Lancets, Auto Lancet, Carrying Case, Owners Manual, Warranty Card Rapid Response Blood Glucose Test Strips (No Coding) Meter 1 Strip 50 04GLU-51 Rapid Response Software (CD) with Cable, Instruction Booklet and Blisterpack CD, Cable 1 Strips 04GLU-49 Rapid Response Blood Glucose Control Solutions (80 H/L/N QC testing) Vials 3 Blood Glucose Meter (No Coding) 04GLU-48 Rapid Response Lancing Device Device 1 04GLU-47 Rapid Response Lancets Lancets

17 Drugs of Abuse Test Strips, Cassettes and Panels 99% accurate Simple to use Easy-to-read results Custom drug combination available from 2-12 tests Multi-test panels conform to the latest HHS guidelines for Instrumented Single-Drug Test Strip Single-Drug Test Cassette Multi-Drug Test Cassette Test Facilities (2010) SAMHSA cutoffs 100 single-drug strips per kit 40 single-drug cassettes per kit 25 multi-drug cassettes per kit 25 multi-drug panels per kit Multi-Drug Panel 14

18 Drugs of Abuse Integrated and Split-Specimen Cups Multi-Drug One Step Cup Multi-Drug Integrated Split-Specimen Cup D2.1-1V to D12.1-1V Easy and convenient onestep collection and test system Test results ready in minutes No urine specimen handling required 25 cups per kit Accommodates 2-18 test strips D2.1-1G29 to D12.1-1G29 Separates urine sample into two chambers; one for initial screening and one for later laboratory confirmation Device can be sent for confirmation by GC/MS Allows for easy documentation; results can be photocopied 25 cups per kit Accommodates 2-12 test strips Specimen Validity Tests Urine Adulteration Test Strip Option Test Sensitivity Specific Gravity URA-1S65 Option 1 Oxidant Low - High Option 3 (Option 1 + 2) ph Nitrite mg/dl Detects Creatinine, Nitrite, Glutaraldehyde, ph, Specific Gravity, Oxidants and Pyridinium Chlorochromate in urine specimens Option 2 Creatinine mg/dl Determines the integrity of a urine sample prior to Drugs of Abuse testing Glutaraldehyde Negative - High Intended for in vitro use 15 All integrated cups come with optional adulteration testing (aids in determining specimen validity)

19 Drugs of Abuse Custom Combinations Create custom combinations to meet your needs. Custom combinations may range from 2-18 substances. The Rapid Response Drugs of Abuse products available for customization include: Single Drug Test Cassette, Panel or Strip Multi-Drug Test Panel Multi-Drug One Step Cup Multi-Drug Integrated Split Specimen Cup A minimum of 1,000 drug tests must be ordered for custom combinations. Please contact your local sales representative for additional questions or requests. Drug Acronym Cutoff (ng/ml) Drug Acronym Cutoffs (ng/ml) 6-Monoacetylmorphine 6-MAM 10* Methadone MTD 300*; 200 Acetaminophen ACE 5000* Methadone Metabolite EDDP 300*; 100* Alcohol ALC 0.02% BAC Methamphetamine MET 1000*; 500*; 300* Amphetamines AMP 1000*; 500*; 300* Methaqualone MQL 300* Barbiturates BAR 300*; 200 Methylenedioxypyrovalerone MDPV 300 Benzodiazepines BZO 500; 300*; 200*; 100 * Methylphenidate MPD 300* Buprenorphine BUP 10*; 5* Methylphenidate Metabolite MPDM 1000* Cocaine COC 300*; 200*; 150 ;100* Morphine MOP 300*; 200*; 100* Cotinine COT 600*; 300*; 200*; 100 Opiate OPI 2000*;1000 Ecstasy MDMA 1000*; 500* Oxycodone OXY 300*; 100* Ethyl Glucuronide (Alcohol) ETG 500*; 1000 Phencyclidine PCP 25* Fentanyl FYL 200*; 20*; 10* Propoxyphene PPX 300* Hydromorphone HMO 250 Synthetic Marijuana/Spice K2 50*; 30 Ketamine KET 1000*; 500; 300; 100 Tramadol TRA 300*; 100* Lysergic Acid Diethylamide LSD 50* Tricyclic Antidepressants TCA 1000* Marijuana THC 200*; 150*; 50*; 25*; 20 Zolpidem ZOL 50* * Health Canada Approved 16

20 Alcohol Breath, Saliva and ETG Urine Tests ETG Urine Test Cassettes ETG-1C9-40 Accuracy >99% Available cutoff: 500 ng/ml Panel can also come with built-in adulteration or dilution testing for Creatinine, Nitrite, Glutaraldehyde, ph, Specific Gravity, Oxidants and Pyridinium Chlorochromate ETG-1C9-40 Ethyl Glucuronide Test Cassette (Urine) Cassette 40 ETG-1P9-25 Ethyl Glucuronide Test Panel (Urine) Panel 25 Digital Alcohol Breath Detector 03DAD-20 Alcohol Breath Tubes ABDO-XX-XX Alcohol Saliva Test Strips AST-2S47-25 Digital Alcohol Breath Detector provides accurate blood alcohol concentration (BAC) levels from 0%-0.4% BAC on a large 3-digit LED display, results in ten seconds Individual Alcohol Breath Tubes available in 0.02%, 0.04%, 0.05%, 0.06% and 0.10% BAC sensitivities depending on local BAC testing requirements Alcohol Test Strips can detect as low as 0.02% BAC AST-2S47-25 Rapid Response Alcohol Test Strip Strip 25 ABD0-XX-XX Rapid Response Alcohol Breath Tube Breath Detector 3 or 20 ABD1-XX-XX Rapid Response Alcohol Breath Tube with Blow Bag Breath Detector 2 or 15 03DAD-20 Rapid Response Digital Alcohol Detector Analyzer 1 03DAD-20F Rapid Response Digital Alcohol Detector Analyzer 1 02MTH-21 Rapid Response Digital Alcohol Detector Mouthpieces Mouthpieces 4 17

21 Accessories Specimen Cups and Collection Accessories Collection Cups 02SPC-2 Safety Lancets 01SLAN-18G-25 A range of collection cups available to suit various testing parameters Available with optional temperature strip Made with polypropylene allowing for clarity and durability, screw on cap 90 ml volume, 45 mm diameter Ideal for strips, cassettes and 1-12 panel drug tests Safety lancets control cross-contamination and hospital acquired infections Suitable for blood drops of microliters Needle 18G (1.5 mm), penetration depth mm Sterile, single use only Nasal Aspirate Specimen Trap 20NAC-40 Nasal aspirate specimen trap is ideal for collection use with Rapid Response Influenza A & B and RSV tests Eliminates possibility of accidental tube separation during specimen transport 02SPC-1a Plastic Collection Cup Cup SPC-2 02SPC-2b Plastic Collection Cup with Temperature Strip Plastic Collection Cup with Temperature Strip (Sterile) Cup 400 Cup NAC-40 Nasal Aspirate Specimen Trap Collection Device 24 01SLAN-18G-25 Safety Lancet Lancet 25 18

22 Contact Information For more information call For Customer Service dial extension 206 For Technical and Product Support dial extension 216 For IT Support dial extension 212 or visit If you have any questions regarding pricing or products please contact your local representative, or Customer Service hours of operation: Monday-Friday 9:00 a.m.-5:30 p.m. EST 570 Hood Road, Unit 23, Markham, Ontario, L3R 4G7, Canada Copyright BTNX Inc All rights reserved. The health related information in this brochure is meant for informational purposes and is not intended to serve as medical advice. While we make every effort to provide you the most accurate and up-to-date information about our products please note that actual products may differ slightly from the specifications or pictures. 19 Rev

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24 570 Hood Road Unit 23 Markham, Ontario, Canada L3R 4G7 PRSRT STD U.S. POSTAGE PAID NIAGARA FALLS, NY PERMIT NO. 15