Evaluation of analytical and clinical performance of the AFIAS Tn-I plus assay - a new point-of-care

Figures & data

Table 1. Precision study of the AFIAS Tn-I plus assay.

Conc.	Repeatability (Within-run)		Within-laboratory		Lot to lot		Reproducibility (Between-run)
[ng/mL]	AVG	CV (%)	AVG	CV (%)	AVG	CV (%)	AVG	CV (%)
0.23	0.25	6.1	0.24	6.6	0.24	7.3	0.23	7.6
0.94	0.92	8.5	0.91	8.1	0.94	8.1	0.94	7.5
7.5	8.08	6.7	7.93	6.7	7.71	7.5	7.73	7.6

Conc: cardiac troponin-I concentrations measured with the AFIAS Tn-I Plus assay. AVG: average; CV: coefficient of variation.

Table 2. 99th percentile upper reference limit (URL) and confidence interval – overall apparently healthy population and subgroups.

Methodology	99^th percentile URL	95%CI
Overall
Robust (n = 820)	0.0296 ng/mL	0.0252 − 0.0333 ng/mL
Non-parametric (n = 790)	0.0260 ng/mL	0.0232 − 0.0283 ng/mL
Male
Robust (n = 410)	0.0300 ng/mL	0.0253 − 0.0412 ng/mL
Non-parametric (n = 394)	0.0288 ng/mL	0.0243 − 0.0313 ng/mL
Female
Robust (n = 410)	0.0239 ng/mL	0.0208 − 0.0312 ng/mL
Non-parametric (n = 395)	0.0228 ng/mL	0.0198 − 0.0241 ng/mL

Table 3. Precision at the 99^th percentile upper reference limit (URL).

Population	99^th percentile (ng/mL)	%CV
Overall	0.0296	8.2
Male	0.0300	7.8
Female	0.0239	9.4

Figure 1. Absolute (A) and relative (B) difference plots when comparing the Abbott ALINITIY high Sensitive Troponin-I assay and the AFIAS Tn-I plus assay.

Figure 2. Passing Bablok regression analysis to compare AFIAS Tn-I Plus and Abbott ALINITY High Sensitive Troponin-I on 460 clinical samples with values ranging from 0.010 ng/ml to 15 ng/ml.

Figure 3. Pearson’s r correlation coefficient to compare AFIAS Tn-I Plus and Abbott ALINITY High Sensitive Troponin-I on 460 clinical samples with values ranging from 0.010 ng/ml to 15 ng/ml.

Figure 4. Passing Bablok regression analysis to compare AFIAS Tn-I Plus and Abbott ALINITY High Sensitive Troponin-I on 129 clinical samples with values ranging from 0.010 ng/ml to 0.1 ng/ml.

Figure 5. Pearson’s r correlation coefficient to compare AFIAS Tn-I Plus and Abbott ALINITY High Sensitive Troponin-I on 129 clinical samples with values ranging from 0.010 ng/ml to 0.1 ng/ml.