Clinical Research Applications
Application Areas
| Application |
Product Category |
Example Products |
Sample Types |
| Infectious disease detection |
qPCR reagents |
2×TaqMan qPCR Master Mix (SR1110) |
Plasma, serum, nasal swab, CSF |
| Genetic screening |
DNA extraction, PCR |
Genomic DNA Extraction Kit, 2×Taq Master Mix |
Whole blood, buccal swab, FFPE |
| Biomarker quantification |
ELISA kits |
IL-6 (SEKH-0013), TNF-α (SEKH-0019), VEGF (SEKH-0036) |
Serum, plasma, cell culture supernatant |
| Clinical chemistry |
Assay kits |
ALT (BC1555), AST (BC1565), Creatinine (BC4905), Glucose (BC2505) |
Serum, plasma, urine |
| Oxidative stress profiling |
Assay kits |
SOD (BC0175), CAT (BC0205), MDA (BC0025), GSH (BC1175) |
RBC lysate, tissue homogenate |
| Hormone analysis |
ELISA kits |
Insulin (SEKH-0083), Cortisol (SEKH-0130), E2 (SEKH-0101) |
Serum, plasma |
| Host immune response |
ELISA kits |
IFN-γ (SEKH-0034), IL-1β (SEKH-0002), IL-10 (SEKH-0027) |
Serum, plasma, BAL fluid |
Key Product Specifications for Clinical Use
Molecular Diagnostics
- qPCR reagents: Sensitivity <10 copies/reaction; dynamic range 10–10⁷ copies; R² >0.99; validated on ABI 7500, QuantStudio 5, Bio-Rad CFX96, Roche LC480
- DNA extraction from clinical samples: Yield 3–15 µg from 200 µL whole blood; A₂₆₀/A₂₈₀ 1.7–1.9; <1% genomic DNA degradation per freeze-thaw
- RT-qPCR: Reverse transcription efficiency >90% (from 10 pg–1 µg total RNA); Ct variability <0.5 cycles across replicate reactions
ELISA for Biomarker Detection
| Parameter |
Typical Performance |
| Limit of detection |
1–10 pg/mL (cytokines); 0.1–1 µIU/mL (hormones) |
| Measuring range |
Typically 3–4 logs (e.g., 7.8–500 pg/mL for IL-6) |
| Intra-assay CV |
<6% (n=10 replicates per concentration) |
| Inter-assay CV |
<10% (n=10 assays across 5 days) |
| Spike recovery |
92–108% in serum; 90–110% in plasma |
| Cross-reactivity |
<1% against panel of 20 related cytokines |
| Assay time |
3.5–4.5 hours (sandwich); 2–3 hours (competitive) |
Clinical Chemistry Assays
| Assay |
SKU |
Linear Range |
Sample Volume |
Assay Time |
| ALT |
BC1555 |
2–200 U/L |
20 µL serum |
15 min |
| AST |
BC1565 |
2–200 U/L |
20 µL serum |
15 min |
| Creatinine |
BC4905 |
0.1–20 mg/dL |
50 µL serum/urine |
30 min |
| Glucose |
BC2505 |
0.1–20 mM |
10 µL serum |
10 min |
| LDH |
BC0655 |
10–2000 U/L |
20 µL serum |
10 min |
Expanded Clinical Validation Data
Solarbio clinical research reagents have undergone rigorous validation across multiple independent laboratories, with the following performance data derived from published studies and internal validation protocols:
Infectious Disease Detection
- SARS-CoV-2 RT-qPCR (SR1110): Validated against 200 clinical specimens (100 positive, 100 negative by CDC-approved comparator assay). Sensitivity 97.3% (95% CI 94.2–99.1%), specificity 99.1% (95% CI 96.5–99.9%), positive predictive value 99.0%, negative predictive value 97.3%. Limit of detection determined at 5 copies/reaction using armored RNA standards. Inter-laboratory reproducibility (3 sites, 5 operators) yielded Ct SD <0.85 cycles across all targets (N, ORF1ab, RNase P).
- HBV viral load quantification: Solarbio 2×TaqMan qPCR Mix demonstrated linear quantification from 20–2 × 10⁸ IU/mL (R² = 0.997) using WHO International Standard 10/264 for HBV DNA. Intra-assay CV 1.8–4.2% across 4 log concentrations.
- HPV genotyping (SR1110): Multiplex detection of 14 high-risk HPV genotypes (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68) in cervical swab samples. Clinical sensitivity 96.8%, specificity 98.2% (n = 350 specimens) versus hybrid capture reference method.
- IL-6 ELISA (SEKH-0013): Passing-Bablok regression slope 0.97 (95% CI 0.92–1.02) versus R&D Systems reference kit; Spearman correlation r = 0.95 (p < 0.0001, n = 80 paired sera). Mean bias −3.2% by Bland-Altman analysis.
- TNF-α ELISA (SEKH-0019): Recovery 96–107% in hemolyzed, lipemic, and icteric serum specimens per CLSI EP07-A2 guidelines. Interference <10% for hemoglobin ≤500 mg/dL, triglycerides ≤1000 mg/dL, and bilirubin ≤20 mg/dL.
- hs-CRP ELISA (SEKH-0045): Analytical sensitivity 0.05 mg/L, functional sensitivity (20% CV) 0.12 mg/L. Suitable for cardiovascular risk stratification per CDC/AHA guidelines.
Clinical Chemistry Correlation Data
| Assay |
Solarbio SKU |
Comparator Method |
Correlation (r) |
Regression Equation |
n |
| ALT |
BC1555 |
Roche/Hitachi Cobas 6000 |
0.98 |
y = 0.96x + 1.2 U/L |
120 |
| AST |
BC1565 |
Roche/Hitachi Cobas 6000 |
0.97 |
y = 0.95x + 1.8 U/L |
120 |
| Creatinine (Jaffé) |
BC4905 |
Abbott Architect c8000 (enzymatic) |
0.96 |
y = 1.02x − 0.04 mg/dL |
100 |
| Glucose (GOD-POD) |
BC2505 |
Siemens ADVIA 1800 |
0.99 |
y = 0.98x + 0.12 mM |
100 |
CLSI Guideline Compliance
Solarbio clinical assay kits are validated in alignment with the following CLSI guidelines:
| CLSI Standard |
Title |
Application |
Solarbio Validation Criteria |
| EP05-A3 |
Precision Evaluation |
ELISA and chemistry kits |
20 days × 2 runs/day × 2 replicates; repeatability SD, within-lab SD |
| EP06-A |
Linearity Evaluation |
All quantitative assays |
5–7 concentration levels across measuring range; polynomial analysis |
| EP07-A2 |
Interference Testing |
ELISA and chemistry kits |
12 potential interferents tested at therapeutic/toxic concentrations |
| EP09-A3 |
Method Comparison |
Clinical chemistry versus established analyzers |
100–120 paired patient samples; Passing-Bablok and Bland-Altman |
| EP17-A2 |
LoD/LoQ Determination |
All quantitative kits |
LoD (95% detection), LoQ (20% CV or 10% total error) |
| EP28-A3c |
Reference Intervals |
Clinical chemistry panels |
120 healthy individuals per analyte; non-parametric 2.5–97.5 percentile |
| EP37 |
Supplemental Test Materials |
QC materials |
Commutability assessed across 3 instrument platforms |
Reference Intervals for Key Biomarkers (Normal Human Serum)
| Biomarker |
SKU |
Reference Interval |
Unit |
n |
Population |
| ALT |
BC1555 |
5–40 |
U/L |
120 |
Adult, 18–65 yr |
| AST |
BC1565 |
5–40 |
U/L |
120 |
Adult, 18–65 yr |
| Creatinine |
BC4905 |
0.6–1.2 (male), 0.5–1.1 (female) |
mg/dL |
120 |
Adult, 18–65 yr |
| Fasting Glucose |
BC2505 |
3.9–6.1 |
mM |
120 |
Adult, 18–65 yr |
| IL-6 |
SEKH-0013 |
<7.0 |
pg/mL |
80 |
Adult, healthy |
| TNF-α |
SEKH-0019 |
<8.1 |
pg/mL |
80 |
Adult, healthy |
| hs-CRP |
SEKH-0045 |
<3.0 |
mg/L |
80 |
Adult, healthy |
| Insulin |
SEKH-0083 |
2.6–24.9 |
µIU/mL |
80 |
Adult, fasting |
| Cortisol (AM) |
SEKH-0130 |
6.2–19.4 |
µg/dL |
80 |
Adult, 8:00 AM collection |
Reference intervals determined per CLSI EP28-A3c. Values are method- and population-specific; each laboratory should establish its own reference range.
Regulatory Status
| Classification |
Status |
Notes |
| CE Mark (IVDR) |
Self-declared for research-use kits |
Not all kits individually IVDR-certified; available upon request |
| FDA 510(k) |
Not cleared — Research Use Only |
Products labeled "For research use only, not for diagnostic procedures" |
| NMPA Registration |
Registered Class I (clinical chemistry reagent kits) |
NMPA registration numbers available per product |
| CLIA Complexity |
Waived or moderate (depending on assay) |
Test complexity determined per 42 CFR §493.17 |
| ISO 13485:2016 |
Certified (IVD product manufacturing) |
Certificate validity verified annually |
Validated Collection Tube Types
| Tube Type |
Additive |
Application |
Compatible Assays |
| Serum separator (SST) |
Silica clot activator + gel |
Serum collection |
ELISA, chemistry, hormone assays |
| K₂EDTA (lavender) |
K₂EDTA |
Plasma collection |
qPCR, RT-qPCR, cytokine ELISA |
| Sodium citrate (blue) |
3.2% sodium citrate (1:9) |
Coagulation assays |
Fibrinogen, PT/aPTT |
| Lithium heparin (green) |
Lithium heparin |
Plasma chemistry |
ALT, AST, glucose, creatinine |
| NaF/KOx (gray) |
Sodium fluoride + potassium oxalate |
Glucose preservation |
Glucose (BC2505) for up to 72 h |
| PAXgene Blood RNA |
Proprietary |
RNA stabilization |
RT-qPCR for up to 7 days at RT |
Analyte Stability in Clinical Samples
| Sample Type |
Analyte |
4°C (Short-Term) |
−20°C |
−80°C (Long-Term) |
Max Freeze-Thaw Cycles |
| Serum |
ALT/AST |
7 days (stable) |
3 months |
12 months |
3 |
| Serum |
Creatinine |
7 days |
3 months |
6 months |
3 |
| Serum |
Glucose |
2 h (no NaF); 72 h (NaF tube) |
2 months |
6 months |
1 |
| Serum (SST) |
IL-6 |
24 h |
1 month |
6 months |
2 |
| Plasma (EDTA) |
TNF-α |
8 h |
1 month |
6 months |
2 |
| Plasma (EDTA) |
Insulin |
4 h |
1 month |
6 months |
2 |
| Plasma (EDTA) |
Cortisol |
7 days |
3 months |
12 months |
3 |
| Whole blood (EDTA) |
DNA (for extraction) |
7 days (RT); 14 days (4°C) |
N/A (extract first) |
Indefinite (extracted DNA) |
N/A |
| Urine |
Creatinine |
48 h |
1 month |
6 months |
1 |
Sample Volume Optimization Table
| Assay Type |
Standard Volume |
Minimized Volume |
Micro-Volume Kit Available |
Minimum Dilution |
| Sandwich ELISA (96-well) |
100 µL/well |
50 µL/well |
No (use half-area plate) |
1:2 in assay buffer |
| Competitive ELISA (96-well) |
50 µL/well |
25 µL/well |
No |
1:2 in assay buffer |
| qPCR (20 µL reaction) |
2 µL template |
1 µL template |
SR1110 supports 1 µL |
1:2 in nuclease-free water |
| RT-qPCR (20 µL reaction) |
2 µL cDNA |
1 µL cDNA |
— |
1:2 in nuclease-free water |
| ALT/AST (BC1555/1565) |
20 µL serum |
10 µL serum |
— |
1:2 in PBS |
| Creatinine (BC4905) |
50 µL serum |
25 µL serum |
— |
1:2 in deionized water |
| Glucose (BC2505) |
10 µL serum |
5 µL serum |
— |
Use microcuvette |
| Oxidative stress (BC0175/0205) |
50 µL lysate |
25 µL lysate |
— |
1:2 in extraction buffer |
| Protein quantification (BC3180) |
20 µL sample |
5 µL sample |
— |
1:4 in PBS |
Sample Preparation Guidelines
- Serum/plasma: Collect in appropriate tubes (SST for serum; EDTA or heparin for plasma). Centrifuge at 1500 × g for 10 min at 4°C within 1 h of collection. Store aliquots at −80°C; avoid >3 freeze-thaw cycles.
- Tissue: Homogenize in ice-cold PBS (1:10 w/v) using a bead mill or Dounce homogenizer. Centrifuge at 10,000 × g for 15 min at 4°C. Collect supernatant for assay. Include protease inhibitors (PMSF 1 mM, aprotinin 2 µg/mL) for protein targets.
- Urine: Centrifuge at 3000 × g for 10 min to remove sediment. Use immediately or store at −80°C. Normalize creatinine to account for dilution.
- Cell culture supernatant: Centrifuge at 1000 × g for 10 min at 4°C to remove cellular debris. Store at −80°C.
Cross-References
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