Comparison |
| Application |
General Chemistry Reagent | Molecular Reagent | Immunoassay Reagent | Molecular Reagent | General Chemistry Reagent |
| CLIA Classification |
CLIA Waived | | | | |
| CLIA Classified |
CLIA Waived | | | | |
| Country of Origin |
Unknown | Unknown | United States | United States | United States |
| For Use With |
For Afinion AS100 Analyzer | For GeneXpert Systems | For BD Viper Instrument | For BD Viper Instrument | For ACE Axcel / ACE Alera Clinical Chemistry Systems |
| Number of Tests |
1 Test | 10 Tests | 1,152 Tests | 1,152 Tests | 450 Tests |
| Product Dating |
McKesson Acceptable Dating: we will ship >= 90 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 | McKesson Acceptable Dating: we will ship >= 90 days |
| Sample Type |
Capillary / Venous Blood Sample | Urine / Vaginal Swab / Endocervical Swab Sample | Urine / Endocervical Swab / Vaginal Swab / Male Urethral Swab Sample | Urine / Endocervical Swab / Vaginal Swab / Male Urethral Swab Sample | Serum / Plasma Sample |
| Specialty |
General Chemistry | Molecular | Immunoassay | Molecular | General Chemistry |
| Storage Requirements |
Requires Refrigeration | | | | Requires Refrigeration |
| Test Category |
HbA1c | Sexual Health | Sexual Health | Sexual Health | General Chemistry |
| Test Format |
Cartridge | Cartridge | | | |
| Test Method |
| | Amplified DNA Assay | | |
| Test Name |
Hemoglobin A1c (HbA1c) | Chlamydia Trachomatis / Neisseria Gonorrhoeae (CT / NG) | Chlamydia Trachomatis / Neisseria Gonorrhoeae (CT / NG) | Neisseria Gonorrhoea (NG) | Aspartate Aminotransferase (AST) |
| Test Type |
Diabetes Management | Real-Time PCR | Infectious Disease | DNA Amplification / Detection | Hepatic |
| Time to Results |
3 Minute Results | 90 Minute Results | | | |
| UNSPSC Code |
41116205 | 41116011 | 41116011 | 41116011 | 41116105 |
| Volume |
15 Cartridges | | 1,152 Tests | | R1: 3 X 12 mL, R2: 3 X 12 mL |
| 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
|
- 90 minute detection and differentiation of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG)
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- Qualitative detection of Chlamydia trachomatis DNA in clinician-collected female endocervical and male urethral swab specimens, patient-collected vaginal swab specimens (in a clinical setting), and male and female urine specimens
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- Qualitative detection of Neisseria gonorrhoeae DNA in clinician-collected female endocervical and male urethral swab specimens, patient-collected vaginal swab specimens (in a clinical setting), and male and female urine specimens
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- For the quantitative determination of aspartate aminotransferase activity in serum and lithium heparin plasma
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