TABLE 2.
Comparison of NGSP-Certified A1C POC Devices
| Characteristic | Bayer A1CNow (22) | Axis-Shield Afinion (21) | Siemens DCA Vantage (20) |
| Physical size | ● Disposable, portable, handheld | ● Bench-top unit | ● Bench-top unit |
| ● Dimensions: | ● Dimensions: | ● Dimensions: | |
| ❍ Depth: 6.35 cm (2.5 in) | ❍ Depth: 34 cm (13.4 in) | ❍ Depth: 27.7 cm (10.5 in) | |
| ❍ Height: 1.0 cm (0.4 in) | ❍ Height: 17 cm (6.7 in) | ❍ Height: 25.4 cm (9.0 in) | |
| ❍ Width: 5.1 cm (2.0 in) | ❍ Width: 19 cm (7.4 in) | ❍ Width: 28.7 cm (11.5 in) | |
| ❍ 0.18 kg (0.4 lb) | ❍ Weight: 5 kg (11 lb) | ❍ Weight: 3.88 kg (9 lb) | |
| Assay methodology | Immunoassay | Boronate affinity separation | Immunoassay (latex agglutination inhibition) |
| Blood sample size (μL) | 5 | 1.5 | 1 |
| Analysis time (min) | 5 | 3 | 6 |
| Reporting A1C range (%) | 4.0–13.0 | 4.0–15.0 | 2.5–14.0 |
| Sources of interference (24) | HbF (when level is 10–15%) | HbF (when level is 10–15%) | HbF (when level is >20%) |
| HbC | |||
| HbS | |||
| Other quantitative tests (moderate complexity requiring quarterly proficiency testing) | None | ● Albumin:creatinine ratio | ● Albumin:creatinine ratio |
| ● Creatinine | ● Creatinine | ||
| ● C-reactive protein and cholesterol (not available in the United States) | ● Microalbumin | ||
| Storage | ● Store the test kit refrigerated (2–8°C) until the expiration date or at room temperature (15–25°C) for up to 4 months. | ● Store the test kit refrigerated (2–8°C) until the expiration date or at room temperature (15–25°C) for up to 3 months. | ● Store the test kit refrigerated (2–8°C) until the expiration date or at room temperature (15–25°C) for up to 3 months. |
| ● Use the test cartridge within 2 minutes after opening the foil pouch. | ● Use the test cartridge within 10 minutes after opening the foil pouch. | ● Use the test cartridge within 5 minutes after opening the foil pouch. | |
| Features | ● Memory capacity: none | ● Memory capacity: 500 patient results and 500 control results | ● Memory capacity: 4,000 patient and control records |
| ● Display: black and white, nontouch | ● Display: color touch | ● Color touch display | |
| ● Power supply: battery | ● Power supply: AC/DC adapter | ● Power supply: AC/DC adapter | |
| ● Calibration: none | ● Calibration: none | ● Calibration: lot specific calibration card | |
| ● Separate test cartridge and sampling device | ● Integrated test cartridge and sampling device | ● Separate test cartridge and sampling device | |
| ● Data export: none | ● Data export: | ● Data export | |
| ● Accessories: one | ❍ USB flash drive | ❍ USB flash drive | |
| ❍ Ethernet port | ❍ Ethernet port | ||
| ❍ RS232 | ❍ Accessories: barcode scanner, onboard printer | ||
| ● Accessories: barcode scanner, purchased separately | |||
| Approximate cost per unit (prices vary by distributor) | $40 for unit with 2 cartridges (for the home-use version) | $3,500 for base station | $2,100–3,600 for base station |
| $170 for unit with 20 cartridges | $120 for 15 single-use testing kits | $75 for 10 single-use testing kits | |
| $60 for 2 control sets | $60 for 2 control sets | ||
| Company Internet address | http://www.ptsdiagnostics.com | http://www.axis-shield.com | http://www.siemens.com |