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. 2022;4:253–274. doi: 10.1016/j.crbiot.2022.04.003

Table 5d.

Portable microfluidics-based methods: device performance in human blood.

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.

a

Reference ELISA utilized samples that were filtered using HYPER system.

b

Units: µg/mL, mg/L, or µmol/L.