Table 4 New biomarker detection technologies.
Information about the Biomarker used for Testing the Detection Technology | Information about the Biomarker Detection Technology | ||||||||||||
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Biomarker | Biomarker molecule type | Biomarker Source | Detected Disease Condition (Detection Type) | Biomarker Levels in Patients | Biomarker Levels in Normal Population | Biomarker Detection Technology | Product Cost | Lower Limit of Detection | Upper Limit of Quantification | Minimum Sample Volume | Detection Time | Technology Readiness for Detecting Biomarker in Non-invasive Source from Patients | Reference |
Paper-based and mobile-phone enabled technologies | |||||||||||||
Human epididymis protein 4 (HE4) | Protein | Urine | Ovarian cancer (D) | 364.5 ng/mL - 458.8 mg/mL | 0.0574 ng/mL - 727.1 ug/mL | Paper-based ELISA + smartphone | N/A | 19.5 ng/mL | 1250 ng/mL | 100 μL | 5 h (may be cut to 15 min) | Within range | |
Mycobacterium tuberculosis nucleic acids | DNA | N/A | Tuberculosis (D) | N/A | N/A | Paper-based Au-nanoprobes + smartphone | N/A | 10 μg/mL | N/A | 5 μL | 65 min (2h30min including PCR amplification) | N/A | |
MMP9 | Protein | Urine | Colorectal cancer (D) | N/A | N/A | Paper lateral flow assay + smartphone/scanner | $2.60 + cost of cellphone | 92 ng/mL | 644 ng/mL | 5 μL | N/A | N/A | |
Thrombin | Protein | Urine | Thrombosis (D) | N/A | N/A | Paper lateral flow assay + smartphone/scanner | $2.60 + cost of cellphone | 72 ng/mL | 504 ng/mL | 5 μL | N/A | N/A | |
Neuropeptide Y | Peptide | Saliva | Post-traumatic stress disorder (P, T) | ∼1.7–5.95 pg/mL(plasma) | 0.014–0.065 pg/mL (saliva), ∼0.21–2.42 pg/mL (plasma) | Paper-Based ELISA + camera/smartphone/scanner/printer | Low cost | 127.59 ng/mL | 21.265 μg/mL | 3 μL | <60 min | Out of range | |
Hepatitis B virus plasmid DNA | DNA | N/A | Hepatitis B (D) | N/A | N/A | Convective polymerase chain reaction + smartphone | N/A | 30 copies per reaction | N/A | 3 μL | 20 min | N/A | |
VEGF | Protein | Inner eye aqueous humor | Proliferative diabetic retinopathy, age-related macular degeneration, retinal vein occlusion (D) | 740.1 ± 267.7 pg/mL, 383 ± 155.5 pg/mL, 219.4 ± 92.1 pg/mL | 14.4 ± 8.5 pg/mL | Paper-based ELISA + Smartphone | Cost of paper-ELISA + cost of cellphone | 33.7 fg/mL | 10 μg/mL | 2 μL | 44 min | Within range | |
Paper-based technologies | |||||||||||||
Chorionic gonadotropin | Protein | Urine | Pregnancy (D) | >2.5 ng/mL | <0.5 ng/mL | Automated paper-based sequential multistep ELISA. + inkjet printing | Low cost | 0.81 ng/mL | 500 ng/mL | 50 μL | 15–25 min | Within range | |
HIV-1 envelope antigen gp41 | Protein | Serum | HIV infection (P) | N/A | N/A | Paper-based ELISA + scanner | Cost of paper-ELISA + $100 for scanner | N/A | N/A | <20 μL | <60 min | N/A | |
Anti-Leishmania antibodies | Protein | Canine blood | Leishmaniasis (D) | N/A | N/A | Paper-based ELISA + scanner | Cost of paper-ELISA + $100 for scanner | 1 mg/mL | N/A | μL range | 60 min | N/A | |
Anti-NC16A autoimmune antibodies | Protein | Blister fluid | Bullous pemphigoid (D) | N/A | N/A | Paper-Based ELISA + desktop scanner | Cost of paper-ELISA + $100 for scanner | 3 ug/mL | 50 μg/mL | 2 μL | 70 min | N/A | |
Lactoferrin | Protein | Tear | Dry eye syndrome (D) | 0.13 ± 0.22 mg/mL | 2.05 ± 1.12 mg/mL | An inkjet-printed microfuidic paper-based analytical device + digital camera | $0.0131 per testing sheet + cost of digital camera | 5 ng/mL | 50 ng/mL | 2.5 μL | 15 min | Within range after dilution | |
Mobile-phone enabled technologies | |||||||||||||
Plasmodium falciparum histidine-rich protein 2 (PfHRP2) | Protein | Serum, Saliva | Malaria (D) | 17–1167 pg/mL (saliva) | 0 | A disposable microfluidic chip + smartphone with embedded circuit | N/A | 16 ng/mL | 1024 ng/mL | 0.5 μL | 15 min | Out of range | |
Bacterial DNA | DNA | N/A | Bacterial infection (D) | N/A | N/A | A disposable micro?uidic chip with primers + a fluorescence detector + smartphone | $350-$600 | 760 DNA copies per μL | N/A | 30 μL | 30 min | N/A | |
Interferon-gamma | Protein | N/A | Latent tuberculosis (D) | 48.69 ± 28.78 pg/ml (blood) | 12.99 ± 5.70 pg/ml (blood) | An opto-acoustic immunoassay + mobile phone technologies ( surface acoustic wave transducer, CMOS camera, LED) | low cost | 17.15 pg/mL | 17.15 ng/mL | N/A | 10 min | Within range | |
Adenovirus DNA | DNA | N/A | Viral infection | N/A | N/A | A microfluidic capillary array + an optical signal amplifier (multi-wavelength LEDs) + smartphone | $180 for capillary array + cost of LED and smartphone | 0.4 ug/mL | 5 μg/mL | 10 μL | N/A | N/A | |
Cortisol | Small molecule | Saliva | Stress, anxiety, depression (D) | 20.7–37.3 ng/mL | 0.4–14.1 ng/mL | Chemiluminescent lateral flow Immunoassay + smartphone with custom-designed 3D printer | Low cost | 0.3 ng/mL | 60 ng/mL | 25 μL | 30 min | Within range | |
N-terminal proBNP molecule | Peptide | Blood | Heart failure (D,P) | 1076 ± 138 pg/mL | 38 ± 4 pg/mL | A disposable biomarker sensing element + HDR image acquisition technique + computer screen photo-assisted technique + smartphone | N/A | 60 pg/mL | 3000 pg/mL | 150 μL | 12 min | Within range | |
IL-6 | Protein | Serum | Cancer (P) | 300- 3500 pg/mL | <300 pg/mL | ELISA + smartphone | N/A | 2 pg/mL | N/A | N/A | 2 hour 40 min | Within range | |
Albumin | Protein | Urine | Kidney disease (D) | >30–300 ug/mL | <30 ug/mL | Fluorescent assay in disposable test tubes + smartphone | $190 + cost of phone | 5–10 μg/mL | 200 μg/mL | 25 μL | 5 min | Within range | |
Other lab-on-a-chip platform technologies | |||||||||||||
Apolipoprotein A1 | Protein | Urine | Bladder cancer (D) | 207.3 -3754.7 ng/mL | ~ 10 ± 8 ng/mL | A negative-pressure-driven microfluidic chip magnetic bead based ELISA + optical measurment device | lower costs than conventional ELISA | 10 ng/mL | 2000 ng/ml | 14.5 μL | 40 min | Within range | |
Minimally invasive finger-prick biomarker technologies | |||||||||||||
C-reactive protein | Protein | Blood | Prostate cancer, colorectal cancer (P), | >3 ug/mL (blood) | <1 ug/mL (blood) | A microtiterplate based ELISA + smartphone | <$660 | 0.3 ng/mL | 81 ng/mL | N/A | <30 min | Within range after dilution | |
HIV-1 gp41 and HIV-2 gp36 | Protein | Blood | HIV infection (P) | N/A | N/A | A low-power, low-cost and compact smartphone dongle of microfluidic ELISA | $34 + + cost of cellphone | 10 μg/mL | N/A | 2 μL | 15 min | N/A | |
N-terminal proBNP molecule | Peptide | Blood | heart failure (D,P) | 1076 +_ 138 pg/mL | 38 +_ 4 pg/mL | A disposable biomarker sensing element + HDR image acquisition technique + computer screen photo-assisted technique + smartphone | N/A | 60 pg/mL | 3000 pg/mL | 150 uL | 12 min | Within range | |
Antibodies against HIV | Protein | Blood | HIV (D) | >0 | 0 | A mobile microfluidic chip for immunoassay | $0.1 per cassette + $0.5 light-emitting diodes+ $6 photodetector + cell phone | N/A | N/A | 1 uL | 20 min | Within range | |
Antibodies against Treponema pallidum | Protein | Blood | syphilis (D) | >0 | 0 | A mobile microfluidic chip for immunoassay | $0.1 per cassette + $0.5 light-emitting diodes+ $6 photodetector + cell phone | N/A | N/A | 1 uL | 20 min | Within range | |
Prostate-specific antigen (PSA) | Protein | Blood | Prostate cancer (D) | >4 ng/mL | <4 ng/mL | A microfluidic purification step + label-free nanosensor detection | low cost | 1.5 ng/mL | N/A | 10 uL | 20min | Within range | |
Carbohydrate antigen 15.3 (CA15.3) | Protein | Blood | Breast cancer (D) | >30 U/ml | <30 U/ml | A microfluidic purification step + label-free nanosensor detection | low cost | 15 U/mL | N/A | 10 uL | 20min | Within range | |
Haemoglobin | Protein | Blood | Anaemia (D) | N/A | N/A | ||||||||
Aspartate aminotransferase (AST) | Protein | Blood | Tuberculosis/HIV (T) | N/A | 5−40 U/L | A paper-based, multiplexed microfluidic assay | <$0.10 per test | 84 U/L | N/A | 15 uL | 15 min | Within range | |
Alkaline phosphatase (ALP) | Protein | Blood | Tuberculosis/HIV (T) | N/A | 30−120 U/L | A paper-based, multiplexed microfluidic assay | <$0.10 per test | 53 U/L | N/A | 15 uL | 15 min | Within range | |
Aspartate aminotransferase (AST) | Protein | Blood | Hepatitis (D) | Acute : ~400 U/L, Chronic: ~ 160 U/L | 5−40 U/L | A micropatterned paper-based microfluidic device + cellphone | low cost | 44 U/L | 400 U/L | 15 uL | 15 min | Within range | |
Alkaline phosphatase (ALP) | Protein | Blood | Liver conditions (D) | N/A | 30−120 U/L | A micropatterned paper-based microfluidic device + cellphone | low cost | 15 U/L | 400 U/L | 15 uL | 15 min | Within range |