Table 1.
Detailed information on evaluated index tests, A) quantitative and B) semi-quantitative.
| A) | ||||||||||||||||||
| Type of test | Quantitative | |||||||||||||||||
| Analyzer name (manufacturer) | QuikRead go (Aidian) | INCLIX (Sugentech) | Spinit (Biosurfit) | LS 4000 (LANSIONBIO) | GS1200 (GenSure Biotech) | STANDARD F 200 (SD BIOSENSOR) | EPITHOD 616 (DXGEN) | IFP-3000 (Xincheng Biological) | ||||||||||
| Analytical measuring interval (mg/L) | 5–120 (plasma and serum) 5–150 (whole blood) | 2.5–300 | 2–300 | 0.5–200 | 0.5–200 | 1–130 (plasma and serum) 1–150 (whole blood) | 2.5–200 | 0.5–200 | ||||||||||
| Sample type | WB*, serum, plasma | WB, serum, plasma | WB, serum, plasma | WB, serum, plasma | WB, serum, plasma | WB, serum, plasma | WB, serum, plasma | WB, serum, plasma | ||||||||||
| Sample volume | 20 μL | 5 μL | 8 μL | 5 μL | 5 μL | 5 μL | 5 μL | 5 μL | ||||||||||
| Storage temperature for consumables | 2–8°C | 2–30°C | 2–8°C | 2–30°C | 2–30°C | 2–30°C | 2–10°C | 2–30°C | ||||||||||
| Shelf-life of consumables | 24 months | 12 months | 18 months | |||||||||||||||
| Estimated preanalytical time | <1 min | 1 min | 5 min | 1 min | 3 min | 3 min | 2 min | 1 min | ||||||||||
| Time to result | 2 min | 5 min | 4 min | 2 min | 3 min | 3 min | 10 sec | 3 min | ||||||||||
| Ability to determine other biomarker(s) using the same device, yes/no, specification | Yes CRP+Hb, wrCRP wrCRP+Hb, HbA1c, STREP A, iFOBT, | Yes hsCRP, PCT, Troponin I, HbA1c, β-hCG, Total IgE | Yes BC, HbA1c, COVID-19 Antibody | Yes PCT, SAA, IL-6, HbA1c, PSA, PG I and PG II, TT3, COVID-19 antigen | Yes PCT, SAA, IL-6, HBP, TNF α, Fungal 1,3 β-D glucan, cTn I, NT-proBNP, BNP, cTnI/Myo/CK-MB, HFABP, D-D, MPO, Lp-PLA2, ST2, S100-β, IGFBP-1, PLGF, β-HCG, FSH, LH, PROG, TES, HGH, AMH, INH B, PRL, E2, VB12, FA, 25-OH-VD, SF, TRF, BGP, PTH, PG I, PG II, GP-17, NGAL, Cys C, β2-MG, RBP, MAU, T3, T4, TSH, TG, HbA1c, INS, C-peptide | Yes U-Albumin FIA, HbA1c | Yes U-Albumin, HbA1c, Hb, COVID-19 antigen, COVID-19 IgM/IgG, COVID-19 IgM | Yes HsCRP, PCT, IL-6, SAA, cTnl, MYO/CK-MB/cTnI, NT-proBNP, D-Dimer, COVID-19 IgG/M, COVID-19 Antigen, COVID-19 Neutralizing Antibody | ||||||||||
| Retail price, consumables (USD) | <3 | <3 | <6 | <1 | <1 | <3 | <2 | <1 | ||||||||||
| Retail price, analyzer (USD) | <1300 | <1000 | <2000 | <600 | <1000 | <2000 | <500 | <500 | ||||||||||
| Analyzer size (mm) | 190 x 140 x 80 | 230 x 250 x 250 | Info not available | 191 x 84.5 x 45 | 315 x 220X 110 | 200 x 240 x 205 | 145 x 210 x240 | 168 x 70 x 44 | ||||||||||
| Analyzer weight | 0.4287 kg | 1.93 kg | Info not available | 0.6 kg | 1.7 kg | 2.7 kg | 1.8 kg | 0.3 kg | ||||||||||
| Data export and connectivity | USB LIS b/HIS c | USB (PDF, Excel) Email and LIS | USB, LIS/HIS | Data transfer via USB not possible d | Data transfer as PDF or xls via USB not possible Storage via LIS | USB, LIS/HIS | USB, Wifi LIS/HIS | Data transfer via USB not possible | ||||||||||
| Practical aspects of the test a | • Analyzer easy to set up and operate • Many languages available • High-throughput measurements are difficult to perform because of the incubation time of 2 min |
• Analyzer easy to handle • “Quick Mode” suitable for testing many samples |
• - Only operated in standard mode e, less suitable for many samples | • “Quick Mode” allows processing of many samples. • -Low battery capacity • -Touchscreen difficult to use with gloves |
• Simple interface • -Very fast workflow possible due to having six cassette slots |
• Only operated in standard mode, less suitable for many samples • Single results cannot be exported |
• Digital data export not possible. • Sample preparation with three different reagents (time consuming and comparatively high consumption of pipette tips) |
• Fast test processing, suitable for many tests (Quick Mode) • No USB. • Touchscreen keyboard small -Sample preparation complex |
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| B) | ||||||||||||||||||
| Type of test | Semi-quantitative | |||||||||||||||||
| Test name (manufacturer) | ACTIM CRP dipstick (ACTIM) | NADAL Dipstick (Nal von minden) | NADAL Cassette (Nal von minden) | ALLTEST Dipstick (Hangzhou Alltest Biotech) | ALLTEST Cassette (Hangzhou Alltest Biotech) | ALLTEST Cassette (Hangzhou Alltest Biotech) | BIOTEST Cassette (Hangzhou Biotest Biotech) | BTNX Quad Line dipstick (BTNX) | BTNX Tri Line Cassette (BTNX) | |||||||||
| Cut-off (mg/L) | ≥10–40 –≤80 | ≥10–40 –≤80 | ≥10–40 –≤80 | ≥10–40 –≤80 | ≥10–40 –≤80 | ≥10 –≤30 | ≥10–40 –≤80 | ≥10–40 –≤80 | ≥10–30 –≤80 | |||||||||
| Sample type | WB, serum, plasma | WB, serum, plasma | WB, serum, plasma | WB, serum, plasma | WB, serum, plasma | WB, serum, plasma | WB, serum, plasma | WB, serum, plasma | WB, serum, plasma | |||||||||
| Sample volume | 10 μL | 10 μL WB 5 μL S/P | 10 μL WB 5 μL S/P | 10 μL | 10 μL | 10 μL | 10 μL WB 5 μL S/P | 10 μL WB 5 μL S/P | 10 μL WB 5 μL S/P | |||||||||
| Storage temperature for consumables | 2–25°C | 2–30°C | 2–30°C | 2–30°C | 2–30°C | 2–30°C | 2–30°C | 2–30°C | 2–30°C | |||||||||
| Shelf-life of consumables | ||||||||||||||||||
| Estimated preanalytical time | 2 min | 2 min | <1 min | 3 min | 5 min | <1 | <1 min | <1 min | 1 min | |||||||||
| Time to result | 5 min | 5 min | 5 min | 5 min | 5 min | 5 min | 5 min | 5 min | 5 min | |||||||||
| Retail price, consumables (USD) | <1 | <1 | <1 | <1 | <1 | <1 | <1 | <5 | <5 | |||||||||
| Practical aspects of the test a | • Non-homogeneous test band intensity (sometimes the middle of the band is stronger than the edges and therefore difficult to interpret) | Easily readable band width with homogeneous staining and uniform, consistent color | Low intensity test bands but mostly homogeneous | • First band intensity differs considerably from the control band (assessment difficult) • Band intensity often very non-homogeneous |
• Band width non-homogeneous -Variations in color intensity | • Bright red background appears (complicates interpretation of line intensity) | • Good band intensity—Homogeneity partly irregular | • Homogeneous bands • Intense band staining |
• Homogeneous bands • Intense band staining |
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n/a: not applicable
WB: whole blood
a Practical aspects were defined based on subjective observations of test performers using the form shown in S1 Fig to systematically collect feedback for all tests.
b LIS: Laboratory information system
c HIS: Hospital information system
d The measurement value can be only read on the device
e Standard mode: one sample per run processed