TABLE 2.

Comparison of NGSP-Certified A1C POC Devices

CharacteristicBayer 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 methodologyImmunoassayBoronate affinity separationImmunoassay
(latex agglutination inhibition)
Blood sample size (μL)51.51
Analysis time (min)536
Reporting A1C range (%)4.0–13.04.0–15.02.5–14.0
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 addresshttp://www.ptsdiagnostics.comhttp://www.axis-shield.comhttp://www.siemens.com