Cardiol Res

Cardiology Research, ISSN 1923-2829 print, 1923-2837 online, Open Access

Article copyright, the authors; Journal compilation copyright, Cardiol Res and Elmer Press Inc

Journal website https://cr.elmerpub.com

Original Article

Volume 17, Number 3, June 2026, pages 190-196

Analytical Evaluation of a Point-of-Care Platform for Glycated Hemoglobin and N-Terminal Pro-B-Type Natriuretic Peptide Testing in Cardiometabolic Care

↓ Figure 1. Method comparison between AFIAS-3 POCT and Tosoh G8 HPLC for HbA1c. (a) Passing–Bablok regression showing strong correlation (r = 0.98, P < 0.0001; slope = 0.95; intercept = 0.32%). The blue area indicates the 95% confidence interval. (b) Bland–Altman plot showing a negligible mean bias of −0.03% (blue line) with 95% limits of agreement (red lines) ranging from −0.60% to +0.53%. HbA1c: hemoglobin A1c; POCT: point-of-care testing; HPLC: high-performance liquid chromatography.

↓ Figure 2. Method comparison between AFIAS-3 POCT and cobas 8000 e602 (ECLIA) for NT-proBNP. (a) Passing–Bablok regression showing very high correlation (r = 0.99, P < 0.0001; slope = 1.24; intercept = −40 ng/L). The blue area indicates the 95% confidence interval. (b) Bland–Altman plot showing a positive mean bias of +1,145 ng/L (blue line) with 95% limits of agreement (red lines) ranging from −3,281 to +5,570 ng/L, reflecting systematic overestimation at higher concentrations. NT-proBNP: N-terminal pro-B-type natriuretic peptide; POCT: point-of-care testing; ECLIA: electrochemiluminescence immunoassay.

↓ **Table 1.** Precision and Accuracy of HbA1c Measurements at Two Quality Control Levels
Analyte	QC level	HbA1c (%)	Mean HbA1c (%)	SD	CV (%)	Bias (%)	TE_obs (%)
HbA1c: glycated hemoglobin; QC: quality control; SD: standard deviation; CV: coefficient of variation; TE_obs: total observed error.
HbA1c	QC1 (low)	5.47	5.22	0.10	1.86	4.5	7.57
	QC2 (high)	9.71	9.63	0.17	1.80	0.8	4.30

↓ Table 1. Precision and Accuracy of HbA1c Measurements at Two Quality Control Levels

Analyte

QC level

HbA1c (%)

Mean HbA1c (%)

CV (%)

Bias (%)

TE_obs (%)

HbA1c: glycated hemoglobin; QC: quality control; SD: standard deviation; CV: coefficient of variation; TE_obs: total observed error.

HbA1c

QC1 (low)

5.47

5.22

0.10

1.86

4.5

7.57

QC2 (high)

9.71

9.63

0.17

1.80

0.8

4.30

↓ **Table 2.** Precision and Accuracy of NT-proBNP Measurements at Two Quality Control Levels
Analyte	QC level	NT-proBNP (ng/L)	Mean NT-proBNP (ng/L)	SD	CV (%)	Bias (%)	TE_obs (%)
NT-proBNP: N-terminal pro-B-type natriuretic peptide; QC: quality control; SD: standard deviation; CV: coefficient of variation; TE_obs: total observed error.
NT-proBNP	QC1 (low)	275.00	249.95	13.23	5.29	9.11	17.84
	QC2 (high)	5,495.30	5,051.15	776.83	15.38	8.08	33.46

↓ Table 2. Precision and Accuracy of NT-proBNP Measurements at Two Quality Control Levels

Analyte

QC level

NT-proBNP (ng/L)

Mean NT-proBNP (ng/L)

CV (%)

Bias (%)

TE_obs (%)

NT-proBNP: N-terminal pro-B-type natriuretic peptide; QC: quality control; SD: standard deviation; CV: coefficient of variation; TE_obs: total observed error.

NT-proBNP

QC1 (low)

275.00

249.95

13.23

5.29

9.11

17.84

QC2 (high)

5,495.30

5,051.15

776.83

15.38

8.08

33.46

↓ **Table 3.** Categorical Agreement Between AFIAS-3 POCT and Tosoh G8 HPLC for HbA1c at the 6.5% Diagnostic Cut-Off
Cut-off = 6.5%	Reference method Tosoh G8	κ value
HbA1c: glycated hemoglobin; POCT: point-of-care testing; HPLC: high-performance liquid chromatography; κ: Cohen’s kappa.
POCT	Positive	26	2	28	0.92
	Negative	0	22	22
	Total	26	24	50

↓ Table 3. Categorical Agreement Between AFIAS-3 POCT and Tosoh G8 HPLC for HbA1c at the 6.5% Diagnostic Cut-Off

Cut-off = 6.5%

Reference method Tosoh G8

κ value

Positive

Negative

Total

HbA1c: glycated hemoglobin; POCT: point-of-care testing; HPLC: high-performance liquid chromatography; κ: Cohen’s kappa.

POCT

Positive

0.92

Negative

Total

↓ **Table 4.** Categorical Agreement Between AFIAS-3 POCT and Cobas 8000 e602 for NT-proBNP at Clinical Decision Cut-Offs
	Cobas 8000 module e602	κ value
NT-proBNP: N-terminal pro-B-type natriuretic peptide; POCT: point-of-care testing; κ: Cohen’s kappa.
Cut-off ≥ 125 ng/L
POCT
Positive	10	1	11	0.88
Negative	1	38	39
Total	11	39	50
Cut-off ≥ 2,000 ng/L
POCT
Positive	37	0	37	0.89
Negative	2	11	13
Total	39	11	50

↓ Table 4. Categorical Agreement Between AFIAS-3 POCT and Cobas 8000 e602 for NT-proBNP at Clinical Decision Cut-Offs

Cobas 8000 module e602

κ value

Positive

Negative

Total

NT-proBNP: N-terminal pro-B-type natriuretic peptide; POCT: point-of-care testing; κ: Cohen’s kappa.

Cut-off ≥ 125 ng/L

POCT

Positive

0.88

Negative

Total

Cut-off ≥ 2,000 ng/L

POCT

Positive

0.89

Negative

Total

↓ **Table 5.** User-Friendliness of the AFIAS-3 for HbA1c and NT-proBNP Point-of-Care Testing
Criteria	Satisfactory (S)	Intermediary (I)	Unsatisfactory (U)	HbA1c results	NT-proBNP results
HbA1c: glycated hemoglobin; NT-proBNP: N-terminal pro-B-type natriuretic peptide; POCT: point-of-care testing; SKUP: Scandinavian Evaluation of Laboratory Equipment for Primary Health Care; QC: quality control; S: satisfactory; I: intermediary; U: unsatisfactory.
Device weight	< 5 kg	5–10 kg	> 10 kg	S, S, I, I, U	I, I, I, I, U
Device size	< 5 × 5 cm	5 × 5 cm < x < 30 × 30 cm	> 30 × 30 cm	I, I, I, I, U	I, I, I, I, U
Additional equipment needed (device, cartridges, consumables)	No	1:2	≥ 3	S, S, S, S, I	S, I, I, I, I
Description of the sample collection process	Yes	Incomplete	No	S, S, S, S, S	S, S, I, S, S
Description of the test process	Yes	Incomplete	No	S, S, S, S, S	S, S, S, S, S
Description of how the results are presented	Yes	Incomplete	No	S, S, S, S, S	S, S, S, S, S
Function and use of the test	Yes	Incomplete	No	S, S, S, S, S	S, S, S, S, S
Presence of the necessary instructions for correct use	Yes	Incomplete	No	S, S, S, S, S	S, S, S, I, I
Training required to collect samples	No	Incomplete	Yes	S, S, S, I	S, S, I, I
Training required to use the device	No	Basic training	Special training	S, S, S, S, I	S, S, I, I
Training necessary for calibration and QC	No	Incomplete	Yes	S, S, I, U, U	S, S, S, I, I

↓ Table 5. User-Friendliness of the AFIAS-3 for HbA1c and NT-proBNP Point-of-Care Testing

Criteria

Satisfactory (S)

Intermediary (I)

Unsatisfactory (U)

HbA1c results

NT-proBNP results

HbA1c: glycated hemoglobin; NT-proBNP: N-terminal pro-B-type natriuretic peptide; POCT: point-of-care testing; SKUP: Scandinavian Evaluation of Laboratory Equipment for Primary Health Care; QC: quality control; S: satisfactory; I: intermediary; U: unsatisfactory.

Device weight

< 5 kg

5–10 kg

> 10 kg

S, S, I, I, U

I, I, I, I, U

Device size

< 5 × 5 cm

5 × 5 cm < x < 30 × 30 cm

> 30 × 30 cm

I, I, I, I, U

Additional equipment needed (device, cartridges, consumables)

1:2

≥ 3

S, S, S, S, I

S, I, I, I, I

Description of the sample collection process

Yes

Incomplete

S, S, S, S, S

S, S, I, S, S

Description of the test process

Yes

Incomplete

S, S, S, S, S

Description of how the results are presented

Yes

Incomplete

S, S, S, S, S

Function and use of the test

Yes

Incomplete

S, S, S, S, S

Presence of the necessary instructions for correct use

Yes

Incomplete

S, S, S, S, S

S, S, S, I, I

Training required to collect samples

Incomplete

Yes

S, S, S, I

S, S, I, I

Training required to use the device

Basic training

Special training

S, S, S, S, I

S, S, I, I

Training necessary for calibration and QC

Incomplete

Yes

S, S, I, U, U

S, S, S, I, I