Product Directory — Diagnostics, Devices & Equipment

OSOM^® H. pylori Test

For the qualitative detection of Helicobacter pylori antibodies in serum, plasma or whole blood as an aid in the diagnosis of H. pylori infection.

Features and Benefits

• Results in 10 minutes or less
• 95.9% sensitivity versus biopsy/histology
• Serum, plasma or whole blood
• Easy-to-read results
• CPT Code: Whole blood 86318QW/Serum or Plasma 86677

Description	Catalog#	Configuration	Storage	Shelf Life
OSOM® H. pylori Test	175	25-Test	Room Temperature	18 months
OSOM® H. pylori Control Kit	176	1-5mL Bottle Positive;1-5mL Bottle Negative	Refrigeration	18 months

View Brochures and Additional Information

• Additional H. pylori Information

• OSOM® H. pylori Test Guide

SEKISUI DIAGNOSTICS 4 Hartwell Place | | Lexington | MA | For over 35 years Sekisui Diagnostics has been committed to providing innovative medical diagnostics to physicians and laboratories. We develop, manufacture, and supply billions of tests each year to the global healthcare market. Our product lines include clinical chemistry and coagulation systems and reagents, point-of-care molecular, rapid tests and immunoassay system as well as enzymes and specialty biochemicals.

Alere Cholestech LDX^® Analyzer

Accurate, actionable results from the leader in point-of-care lipid testing.

The CLIA-waived Alere Cholestech LDX^® Analyzer is engineered for confidence, providing accurate, actionable, and readily accessible results that have set the standard in point-of-care lipid profile, cholesterol, and glucose testing.

Test fasting lipid profile: total cholesterol (TC), HDL & LDL cholesterol, and triglycerides (TRG) for risk assessment and lipid management. The Alere Cholestech LDX^® System provides lab accurate results in just five minutes from a small fingerstick sample.

Benefits of the Alere Cholestech LDX® Analyzer:

• CLIA-waived – no special training required
• Rapid results – enables face-to-face counseling with patients
• Fingerstick sampling – less painful and time consuming
• Small sample size (40 µL) – easy to obtain
• Lab accurate results
• Improved office efficiencies – eliminates costly call backs to labs and patients

Simple 3-Step Testing:
Testing full lipid profile and glucose is as easy as 1, 2, 3:

1. Perform a fingerstick and collect the sample with a capillary tube within 10 seconds.
2. Dispense the sample into the test cassette.
3. Insert the cassette and press the RUN button.

Relevant Clinical Areas:

1. Family practices
2. Internal medicine practices
3. Pediatric practices
4. Urgent care centers
5. Cardiology practices
6. Endocrinology practices
7. Community health centers
8. Hospital wellness programs

Click Images to View Larger

• Alere Cholestech LDX Adult Data Sell Sheet
• Alere Cholestech LDX Tech Brief
• LDX Infographic
• PediatricTesting Guidelines

ABBOTT RAPID DIAGNOSTICS xxxx my street | | concord | NH | Abbott is a world leader in rapid diagnostics at the point of care, with a focus on cardio metabolic disease, infectious disease and toxicology.

Afinion^™ 2
Simply More Efficient.

Improve the way you monitor and manage your patients

The Afinion^™ 2 analyzer is a compact, rapid, multi-assay analyzer that provides valuable near patient testing at the point-of-care.

With the Afinion^™ System, there's no need to send test results to the lab or spend time tracking them down. That way you can keep your focus where it belongs – on the patient.

Benefits of the Afinion^™ 2 Analyzer:
Multiple analytes on one instrument

• The Afinion^™ 2 analyzer makes it fast and easy to test quantitative determinations of HbA1c and ACR.
• HbA1c test is CLIA Waived

Short assay times

• HbA1c results in 3 minutes
• ACR results in 5 minutes

Multiple sample types

• The analyzer is designed to enable simple and fast on-the-spot testing, regardless of the sample type, which may be whole blood or urine, and to deliver accurate results during patient consultation for improved patient management.

Connected

• The Afinion^™ 2 analyzer can reliably transfer test information to a HIS or LIS system. The Afinion^™ 2 Analyzer automatically transfers patient and control results via TCP/IP networking using the protocols POCT1-A, HL7, ASTM 1381-85 (low level) or ASTM 1394-97 (high level), selectable by configuration.

All-in-one test cartridge

• The analyzer and Test Cartridges have been precision engineered with each test cartridge containing an integrated sample collection device and all necessary reagents for a single test.

Automatic self-check system

• The Afinion^™ 2 analyzer eliminates erroneous results with integrated error detection and self-check systems.

No additional calibration necessary

• Each Afinion^™ 2 analyzer has a fixed factory calibration. Each lot of an Afinion^™ test includes calibration data stored in the barcode label. The lot calibration data is read by the integrated camera and used for calculating results.

3-Step Procedure

1. Collect the sample with the integrated sampling device.
2. Place the sampling device back in the test cartridge.
3. Place the test cartridge in the analyzer and close the lid. The processing starts automatically

Click Images to View Larger

• Abbott Afinion Analyzer

ABBOTT RAPID DIAGNOSTICS xxxx my street | | concord | NH | Abbott is a world leader in rapid diagnostics at the point of care, with a focus on cardio metabolic disease, infectious disease and toxicology.

CoaguChek® XS Plus

Simplified testing with enhanced connectivity for professional use
This small, battery-powered, handheld meter is portable and efficient, ideal for mid to high-volume clinical settings. Plus, you can test and treat in one appointment, using the fingerstick test that patients prefer.

Accurate

• 97% accuracy to lab for confidence in results*
• Only handheld, CLIA-waived PT/INR monitoring system that neutralizes therapeutic levels of heparin and low molecular weight heparin within a specified range. See package insert for more information.
• INR corrected for wide range of hematocrit
• Two levels of built-in, onboard controls within the test chamber — no external QC necessary

Easy to use

• Test results in about 1 minute with a small 8 µl sample
• Large top- and side-dosing area enables easy sample application
• Outside meter blood application — minimizes potential for cross-contamination
• Calibration information is provided by a code chip included in all strip vials – no manual calibration, pipetting or preparation of reagents are needed.
• Up to 21-month strip shelf life from date of manufacture — no refrigeration needed
• Icon-driven, color touchscreen interface

Smart

• Stores 2,000 patient and 500 optional liquid QC results
• Ability to denote patient ID in several fields and add comments after results
• Data storage for up to 60 code chips
• Bidirectional data transfer with Roche cobas® IT1000 and other industry leading connectivity systems
• Operator and QC lockout capabilities

*97% correlation with lab results using Dade Innovin reagent on a Sysmex 560 Analyzer. See package insert for more information. CoaguChek XS PT Test [package insert 05967694001(03)]. Indianapolis, Ind.: Roche Diagnostics; 2013

• CoaguChek XS Plus Brochure

• CoaguChek Product Video

ROCHE DIAGNOSTICS 9115 Hague Road | Bldg. H | Indianapolis | IN | Personalised Helathcare (PHC) is based on the observation that patients with the same diagnosis react to the same treatment in different ways

CoaguChek® XS Meter

Accurate

• 97% accuracy to lab for confidence in results*
• Only handheld, CLIA-waived PT/INR monitoring system that neutralizes therapeutic levels of heparin and low molecular weight heparin within a specified range. See package insert for more information.
• Two levels of built-in, onboard controls within the test chamber

Easy to use

• Test results in about one minute with a small 8 µl sample
• Large top- and side-dosing area enables easy sample application
• Outside meter blood application — minimizes potential for cross-contamination
• Up to 21-month strip shelf life from date of manufacture — no refrigeration needed

*97% correlation with lab results using Dade Innovin reagent on a Sysmex 560 Analyzer. See package insert for more information. CoaguChek XS PT Test [package insert 05967694001(03)]. Indianopolis, IND.: Roche Diagnostics; 2013

• CoaguChek XS Brochure

• CoaguChek Product Video

ROCHE DIAGNOSTICS 9115 Hague Road | Bldg. H | Indianapolis | IN | Personalised Helathcare (PHC) is based on the observation that patients with the same diagnosis react to the same treatment in different ways

cobas® Influenza A/B assay

The cobas® Influenza A/B assay is the first CLIA-waived, real-time PCR test to detect Influenza A and B in ~20 minutes. Available for use in non-traditional testing sites, including ERs, physician offices, pharmacy clinics and other urgent care settings.

Benefits:

• Lab-quality performance in the detection and differentiation of Influenza A and Influenza B
• Fast results—20-min. turnaround time
• Simplicity—minimal hands-on time, walk-away test with easy results interpretation
• Supports timely, confident treatment decisions

ROCHE DIAGNOSTICS 9115 Hague Road | Bldg. H | Indianapolis | IN | Personalised Helathcare (PHC) is based on the observation that patients with the same diagnosis react to the same treatment in different ways

cobas® Strep A assay

The cobas® Strep A assay is a CLIA-waived, real-time PCR test for the detection of Streptococcus group A in throat swab specimens from patients with signs and symptoms of pharyngitis. With excellent sensitivity and specificity, this assay provides the reassurance needed when deciding whether or not to treat with antibiotics.

Benefits:

• Extraordinary performance in the detection of Streptococcus pyogenes (Group A Strep)
• Fast results, 15-min. turnaround time
• Ease of use—minimal hands-on-time, objective, unambiguous results
• No confirmation require at time of visit for confident treatment decisions

ROCHE DIAGNOSTICS 9115 Hague Road | Bldg. H | Indianapolis | IN | Personalised Helathcare (PHC) is based on the observation that patients with the same diagnosis react to the same treatment in different ways

cobas® Influenza A/B & RSV assay

The cobas Influenza A/B & RSV assay is the first CLIA-waived, real-time PCR test that differentiates Influenza A, Influenza B and RSV in 20 minutes. It's available for use in hospitals, physician offices and urgent care settings.

Benefits:

• Lab-quality performance in the detection and differentiation of Influenza A, Influenza B and RSV strains
• Fast results, 20-min. turnaround time
• Simplicity—minimal hands-on time, walkaway test with easy results interpretation
• Supports timely, confident treatment decisions

ROCHE DIAGNOSTICS 9115 Hague Road | Bldg. H | Indianapolis | IN | Personalised Helathcare (PHC) is based on the observation that patients with the same diagnosis react to the same treatment in different ways

 The BTA stat® test is a point of care technology for the early detection of recurrent bladder cancer. This method uses monoclonal antibodies to detect the presence of bladder tumor associated antigen in urine.  It is a single-step, rapid immunochromatographic assay for bladder tumor-associated antigen in voided urine.  The specificity of the BTA stat® test was 93 - 95% in patients with non-genitourinary diseases and cancers and healthy individuals tested as part of a multi-center study.  The test has a sensitivity that is considerably higher than voided urine cytology, enabling detection of recurrent early stage and grade cancers that cytology often misses.  Requiring three drops of urine, the result is delivered in only five minutes.  The appearance of a line in the patient window indicates a positive result.  The BTA stat® test requires one voided urine sample with no sample preparation.  The BTA stat® test is CLIA waived and also available for prescription home use.

POLYMEDCO, INC. 510 Furnace Dock Road | | Cortlandt Manor | NY | Polymedco Inc. is a leading manufacturer, marketer, and distributer in the clinical laboratory marketplace. Polymedco supplies clinical diagnostic test kits and devices that are specialized in chemistry, hematology and cancer.

Purchasing A1CNow+

A1CNow+ is sold exclusively though our network of distributors in the United States and abroad. If you're interested in learning more about purchasing A1CNow+ for your practice, please visit our A1CNow+ distributor listings.

Billing for A1CNow+

Billing for A1CNow+ is simple, as well-established billing codes and procedures are used.

1) CPT (Current Procedure Terminology) Codes

83037QW (must use QW). The Medicare National Limitation Amount (NLA) is $21.06, in most states.

36416 Collection of capillary blood specimen (e.g. finger, heel, ear stick). Medicare does not reimburse for 36416. Private pay average payment varies ($3 to $10). The A1CNow+ is approved for use with either a capillary or venous blood specimen.

36415 Collection of venous blood by venipuncture. Medicare reimbursement for a venipuncture is $3. Private pay average payment may vary. The A1CNow+ is approved for use with either a capillary or venous blood specimen.

Note 1: The CPT code 83037QW service may be billed when performed in a physician's office using a device cleared by the FDA for home use. CPT code 83037QW is not intended to report an A1C test that is obtained in the patient's home or by the patient or family. CPT code 83037QW may not be reported when the test is performed using a desk top analyzer or other devices not approved by the FDA for home use. It would be unusual for a clinical laboratory to report 83037QW.

Note 2: 83037 should be used with the QW modifier when used in the physician office setting. The QW modifier (e.g. 83037QW) indicates that the test and the laboratory has received a CLIA certificate of waiver. The A1CNow+ has been categorized as a waived test under the 1988 CLIA regulations.

Note 3: CPT code 83037QW became available in 2006, and some insurers have already implemented and utilized this new code. Other insurers continue to use 83036QW. Physicians should check with local insurers to confirm CPT and ICD-9 codes that are appropriate. See also Medicare National Coverage Determinations (NCD) Coding Policy Manual and Change Report (Section 190.21 - Glycated Hemoglobin/Glycated Protein).

The Centers for Medicare and Medicaid Services (CMS) has indicated the availability of this code and the use of the QW modifier.

2) Medicare Coverage Policies on Frequency of Testing

CMS has issued national Medicare policies for coverage of glycated hemoglobin/glycated protein clinical laboratory tests:

• The test is also valuable to assess hyperglycemia, a history of hyperglycemia or dangerous hyperglycemia.
• The test may not be reasonable and necessary to perform more often than every three months on a controlled diabetic patient to determine if metabolic control is within range.
• The test may not be covered if performed more frequently than once a month for diabetic pregnant women.
• Testing for uncontrolled Type 1 or Type 2 diabetes may require testing more than 4 times per year.
• Testing every 1-2 months may be appropriate in the patients whose diabetes regimen has been altered to improve control.
• Testing pregnant women with diabetes or gestational diabetes every month may be reasonable and necessary.
• Medical necessity documentation must support such testing in excess of the above guidelines.
  
  3) E & M Code (Evaluation and Management Code)
  
  Physician interpretation of test results is considered to be part of the evaluation and management services provided to a patient during an office visit and is not separately billable. For existing patients, codes 99212 - 99215 should be billed and the code used depends on the complexity of the visit (use codes 99201 - 99204 for new patients).
  
  E & M Code 99211 'Clinic Days'
  If a patient sees a nurse or other non-physician health care professional for the purpose of HbA1C testing (for example, to monitor insulin therapy) and the nurse takes vital signs, compares the results of the HbA1C test to predetermined guide lines, and advises the patient accordingly, E & M code 99211 may be billed.
  
  4) ICD-9 Codes
  
  An appropriate diagnosis (ICD-9) code (or narrative description) must be identified in the patient's medical record and reported on the claim form to the patient's insurer for each service or supply billed under Medicare Part B. ICD-9-CM is an acronym for International Classification of Diseases, 9th Revision, Clinical Modification. When a patient presents with an illness, the ICD-9 code is determined by the 'signs and symptoms' that most accurately describe the patient's condition.
  
  5) Certificate of CLIA Waiver
  
  A1CNow+ is classified as a CLIA Waived Category test by the FDA. A CLIA certificate is required any time a clinical laboratory test is performed; however, performance of waived category tests require only a CLIA Certificate of Waiver. Certificate of Waiver labs must register with Medicare, pay the fee every two years and agree to follow manufacturer's instructions in performing clinical lab tests.
  
  To apply for a Certificate of Waiver, click on www.cms.hhs.gov/clia/cliaapp.asp, and download a CLIA application form (CMS-116), follow the instructions provided, then send it to the appropriate state agency. A list of State Agency addresses is also available on the Internet at www.cms.hhs.gov/clia/ssa-map.asp.

BAYER HEALTHCARE 510 Oakmead Parkway | | Sunnyvale | CA | Bayer's A1CNow provides a fast and easy way of obtaining accurate A1C results.