Table 5d.
Portable device vs. reference | EE-µPAD, vs. ELISA | Tidbit with HYPER platform, vs. ELISAa | Tidbit without HYPER platform, vs. ELISA |
---|---|---|---|
Vitamin A biomarkerf | RBPb | RBPb | RBPb |
Sample type | Whole blood | Whole blood | Serum |
Study population | 95 adults (commercial) | 12 adults | 43 adults (commercial) |
Concentration difference | NR | NR | NR |
Correlation coefficient | NR | NR | 0.75 |
R2 (index, unless specified) | NR | Index: 0.81 vs. ref: >0.99 | 0.56 |
Regression equation | NR | Slope = 0.99 | Slope = 0.97 |
RMSE, index vs. ref | NR | 3.75 vs. 1.3 µg/mL | 4.34 µg/mL vs. NR |
Operational range | ∼10–70 µg/mL (graph) | ∼5–20 µg/mL (graph) | 2.2–20 µg/mL (0.10–0.95 µmol/L) |
VAD or VAI (%), index vs. ref | <16.3 µg/mL: AUC = 0.7139 vs. 17.2% | NR | <14.7 µg/mL (≤0.70 µmol/L): NR vs. 9.3% |
Precision | |||
Sensitivity | 75% at MFR cutoff, 0.831 | NR | 100% |
Specificity | 62.3% at MFR cutoff, 0.831 | NR | 100% |
Intra-assay %CV | 10.8% vs. 3.9% | 20.3% deviation per test strip, recommend taking average of 3 test strips | NR |
Inter-assay %CV | NR | NR | NR |
Inter-observer %CV | NR | NR | NR |
Bland Altman analysis comments | NR | NR | Bias at −0.05 µg/mL (-2.3 nmol/L) |
Reference | (Lee et al., 2016) | (Lu and Erickson, 2017, Lu et al., 2017, Lu et al., 2018) | (Lu and Erickson, 2017, Lu et al., 2017) |
Notes:MD, mean difference; MFR, multi-faceted ratio i.e., the ratio of the light transmission in the test area to that in the background control area, calculated for RBP for each sample repeat. NR, not reported; RE, retinol equivalents defined as the sum of retinol and retinyl esters, equal to 3.3 International Units (IU) of vitamin A or as 1 µg (units reported by manufacturer—however, retinol activity equivalents (RAE) are the preferred unit for reporting (Institute of medicine, 2001); RMSE, root mean squared error; VAD, vitamin A deficiency; VAI, vitamin A insufficiency.
Reference ELISA utilized samples that were filtered using HYPER system.
Units: µg/mL, mg/L, or µmol/L.