Table 1.
Impact of Buzzy® on routine immunochemistry laboratory testing
| Diagnostic blood specimen collection procedures | |||||||
|---|---|---|---|---|---|---|---|
| Tests | Units | Desirable Bias (%) | CVa | Buzzy® | Gold standard | Mean % difference | p value |
| COL** | (mmol/L) | 4.0 | 1.8 | 4.73 ± 0.7 | 4.58 ± 0.7 | 3.2 | 0.0002 |
| HDL* | (mmol/L) | 5.2 | 4.3 | 1.35 (1.11–1.64) | 1.30 (1.07–1.63) | 3.7 | 0.0079 |
| TG** | (mmol/L) | 10.7 | 2.0 | 1.55 ± 0.6 | 1.51 ± 0.6 | 2.6 | 0.0101 |
| TP** | (g/L) | 1.2 | 1.2 | 80.1 ± 4.4 | 78.9 ± 3.6 | 1.5 | 0.0244 |
| ALB** | (g/L) | 1.3 | 1.2 | 48.9 ± 3.7 | 47.9 ± 3.4 | 2.0 | 0.0135 |
| CRP* | (mg/L) | 21.8 | 1.3 | 50.0 (50.0–50.1) | 49.8 (49.8–50.0) | 0.4 | 0.7500 |
| UREA** | (mmol/L) | 5.5 | 2.6 | 9.35 ± 1.8 | 9.64 ± 1.7 | −3.1 | 0.0004 |
| CRE* | (μmol/L) | 3.8 | 2.5 | 73.4 (61.9–108.7) | 72.5 (61.9–105.2) | 1.2 | 0.7764 |
| UA** | (μmol/L) | 4.9 | 1.0 | 299.7 ± 92.5 | 300.2 ± 89.2 | −0.2 | 0.8494 |
| ALP** | (μkat/L) | 6.4 | 2.7 | 1.19 ± 0.3 | 1.14 ± 0.3 | 4.2 | 0.0232 |
| Lipase* | (μkat/L) | 10.1 | 2.8 | 2.12 (1.34–2.91) | 2.08 (1.30–2.93) | 1.9 | 0.2483 |
| AMYL** | (μkat/L) | 7.4 | 0.8 | 1.29 ± 0.3 | 1.24 ± 0.3 | 3.9 | 0.0069 |
| AST* | (μkat/L) | 5.4 | 1.2 | 0.49 (0.37–0.60) | 0.44 (0.37–0.61) | 10.2 | 0.8217 |
| ALT** | (μkat/L) | 12.0 | 1.3 | 0.61 ± 0.2 | 0.58 ± 0.2 | 4.9 | 0.1253 |
| GGT* | (μkat/L) | 10.8 | 1.6 | 0.54 (0.37–0.81) | 0.53 (0.37–0.80) | 1.8 | 0.0232 |
| LDH** | (μkat/L) | 4.3 | 1.5 | 7.32 ± 1.0 | 7.19 ± 1.2 | 1.8 | 0.1132 |
| CK** | (μkat/L) | 11.5 | 3.3 | 2.25 ± 1.5 | 2.14 ± 1.4 | 4.9 | 0.0035 |
| TBil* | (μmol/L) | 11.4 | 2.2 | 10.3 (5.1–13.7) | 8.6 (5.1–13.7) | 16.5 | 0.1736 |
| P** | (mmol/L) | 3.2 | 3.0 | 1.30 ± 0.2 | 1.32 ± 0.2 | −1.5 | 0.0717 |
| Ca** | (mmol/L) | 0.8 | 0.7 | 2.37 ± 0.1 | 2.36 ± 0.1 | 0.4 | 0.5320 |
| Mg** | (mmol/L) | 1.8 | 1.2 | 0.81 ± 0.07 | 0.81 ± 0.06 | 0.0 | 0.7192 |
| Fe* | (μmol/L) | 8.8 | 2.6 | 14.1 (12.6–18.0) | 14.9 (12.4–17.2) | −5.7 | 0.6817 |
| Transferrin** | (g/L) | 1.3 | 1.2 | 2.31 ± 0.3 | 2.27 ± 0.3 | 1.7 | 0.0266 |
| Na** | (mmol/L) | 0.3 | 1.0 | 144.3 ± 1.9 | 144.3 ± 1.8 | 0.0 | 1.000 |
| K** | (mmol/L) | 1.8 | 1.5 | 4.0 ± 0.4 | 4.0 ± 0.3 | 0.0 | 0.6590 |
| Cl* | (mmol/L) | 0.5 | 1.0 | 102 (101–103) | 102 (101–103) | 0.0 | 0.2755 |
| GLU* | (mmol/L) | 2.2 | 1.5 | 4.66 (4.27–5.11) | 4.66 (4.33–5.11) | 0.0 | 0.9987 |
| Cortisol** | (nmol/L) | 12.5 | 3.7 | 223.9 ± 99.0 | 198.4 ± 104.2 | 11.4 | 0.0317 |
| Insulin* | (pmol/L) | 15.5 | 5.9 | 66.0 (30.0–125.8) | 66.4 (24.2–110.5) | −0.6 | 0.3757 |
| TSH** | (mU/L) | 7.8 | 3.5 | 1.33 ± 0.6 | 1.28 ± 0.6 | 3.8 | 0.0074 |
| T3** | (nmol/L) | 4.8 | 2.1 | 2.01 ± 0.2 | 2.00 ± 0.2 | 0.5 | 0.2723 |
| FT3* | (pmol/L) | 4.8 | 2.2 | 0.054 (0.050–0.059) | 0.055 (0.052–0.059) | −1.8 | 0.6909 |
| T4** | (nmol/L) | 3.0 | 1.3 | 90.7 ± 14.4 | 89.6 ± 14.5 | 1.2 | 0.1661 |
| FT4* | (pmol/L) | 3.3 | 1.4 | 13.4 (12.0–15.2) | 13.2 (11.7–15.2) | 1.5 | 0.3265 |
| HI* | NA | NA | 0.8 | 4.07 ± 0.22 | 4.02 ± 0.20 | 1.2 | 0.7573 |
The bold p values are statistically significant (p < 0.05) and bold mean % differences represent clinically significant variations, when compared with desirable bias [19]
* Non-normal distribution; the values are presented as median (interquartile range); p value represents the significance by Wilcoxon ranked-pairs test
** Normal distribution; the values are presented as mean ± standard deviation; p value represents the significance by paired student’s t test
NA not available [19], ALB albumin, ALP alkaline phosphatase, ALT alanine aminotransferase, AMYL amylase, AST aspartate aminotransferase, Ca calcium, CK creatine kinase, Cl chloride, COL total cholesterol, CRE creatinine, CRP c-reactive protein, Fe iron, FT3 free triiodothyronine, FT4 free thyroxine, GGTg-glutamyltransferase, GLU glucose, HDL HDL-cholesterol, HI haemolysis index, K potassium, LDH lactate dehydrogenase, Mg magnesium, Na sodium P phosphorus, TBil total bilirubin, TG triglycerides, TP total protein, TSH thyroid-stimulating hormone, T3 total triiodothyronine, T4 total thyroxine, UA uric acid