Comparison |
| CLIA Classification |
CLIA Waived | CLIA Waived Lithium Heparin Whole Blood | | CLIA Moderate Complexity | CLIA Waived |
| CLIA Classified |
CLIA Waived | CLIA Waived Sample Dependent | | CLIA Non-Waived | CLIA Waived |
| Country of Origin |
Unknown | United States | Poland | Canada | Canada |
| For Use With |
For Afinion AS100 Analyzer | For Piccolo Blood Chemistry Analyzer / Piccolo Xpress Chemistry Analyzers | For Small Clinitek Systems | For i-STAT1 System | For i-STAT System Critical Blood Analyzer |
| Number of Tests |
1 Test | | | 9 Tests | 25 Tests |
| Product Dating |
McKesson Acceptable Dating: we will ship >= 90 days | McKesson Acceptable Dating: we will ship >= 30 days | McKesson Acceptable Dating: we will ship >= 90 days | McKesson Acceptable Dating: we will ship >= 30 days | McKesson Acceptable Dating: we will ship >= 30 days |
| Sample Type |
Capillary / Venous Blood Sample | Lithium Heparin Whole Blood / Lithium Heparin Plasma / Serum Sample | Urine Sample | Whole Blood Sample | |
| Storage Requirements |
Requires Refrigeration | Requires Refrigeration | | Requires Refrigeration | Requires Refrigeration |
| Test Category |
HbA1c | General Chemistry | General Chemistry | General Chemistry | General Chemistry |
| Test Format |
Cartridge | Disc | Test Strip | Cartridge | Cartridge |
| Test Method |
| | Albumin, Creatinine, AC Ratio | | |
| Test Name |
Hemoglobin A1c (HbA1c) | ALB, ALP, ALT, AST, BUN, Ca, Cl-, CRE, GLU, K+, Na+, TBIL, tCO2, TP | Microalbumin | Sodium / Potassium / Chloride / Ionized Calcium / Urea Nitrogen / Glucose / Creatinine / Hematocrit / TCO2 | Creatinine |
| Test Type |
Diabetes Management | Metabolic Assay | Renal | Renal | Renal |
| Time to Results |
3 Minute Results | 12 Minute Results | | 2 Minute Results | |
| UNSPSC Code |
41116205 | 41116104 | 41116138 | 41115808 | 41115808 |
| Volume |
15 Cartridges | 10 Disc / Box | 25 Strips | 25 Cartridges | |
| Application |
General Chemistry Reagent | General Chemistry Reagent | General Chemistry Reagent | General Chemistry Reagent | General Chemistry Reagent |
| Specialty |
General Chemistry | General Chemistry | General Chemistry | General Chemistry | General Chemistry |
| Features and Benefits |
- The HbA1c Test Cartridge contains all reagents necessary for the measurement of glycated hemoglobin
- Test cassette includes an integrated sampling device
- Sample volume: 1.5 µL
- Assay time: 3 minutes
- Measuring range: 4 - 15% HbA1c
- Hb-range: 6 - 20 g/dL
- Total imprecision, external studies: < 3% CV
- Reports DCCT / UKPDS aligned values
- No influence from Hb variants like HbC, HbD, HbE, HbF, HbJ and HbS
- No influence from carbamylated or pre-glycated hemoglobin
- Sample material: Capillary blood or anticoagulated venous blood (EDTA, citrate or heparin)
- Kit size: 15 tests - separately packed cartridges
- The Afinion™ HbA1c Test Cartridges are stable until the expiry date only when stored refrigerated in sealed foil pouches
- The Afinion™ HbA1c Test Cartridges can be stored in unopened foil pouches at room temperature for 90 days
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- Intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), calcium, chloride, creatinine, glucose, potassium, sodium, total bilirubin, total carbon dioxide, total protein, and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma, or serum
- CLIA Waived: Use lithium heparin whole blood, only
- Moderate Complexity: Use lithium heparin whole blood, lithium heparin plasma, or serum
- Store reagent discs in their sealed pouches at 2-8°C (36-46°F)
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- USP Controlled Room Temperature
- A dip-and-read urinalysis product available for the CLINITEK Status® systems, CLINITEK 50, or CLINITEK 100 Urine Chemistry Analyzers and the appropriate software
- Clinitek® Microalbumin Strips provide albumin, creatinine and albumin-to-creatinine ratio results in one minute
- Microalbumin product is useful to test for microalbuminuria in patients with diabetes or hypertension in order to detect early kidney disease
- CLINITEK Microalbumin 2 Strips are CLIA waived when run on the CLINITEK Status systems and CLINITEK 50 Analyzers - certificate of CLIA waiver is required to perform these tests in a waived setting
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- The i-STAT CHEM8+ cartridge with the i-STAT 1 System is intended for use in arterial or venous whole blood in point of care or clinical laboratory settings
- Each i-STAT single-use cartridge uses advanced biosensor technology that applies microfluidics to process the most comprehensive range of clinical tests in a single platform, allowing clinicians to access the time-sensitive diagnostic information they need
- To perform a test, 2 to 3 drops of blood are applied to a cartridge, which is then inserted into the i-STAT handheld
- Prior to running a test, each cartridge initiates a series of preset quality control diagnostics, from monitoring the quality of the sample to validating the reagent
- Each test cartridge contains chemically sensitive biosensors on a silicon chip that are configured to perform specific tests
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