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For Research Use Only (RUO)
$876.00
Sku: 1402427
Product Description
One-step double-antibody sandwich ELISA for quantitative detection of Human Serum Albumin (HSA). The kit uses pre-coated microtiter strips with polyclonal anti-HSA capture antibody. Calibration standards (or samples) and HRP-conjugated anti-HSA detection antibody are added simultaneously (one-step format), incubated, washed, then developed with TMB substrate; HRP catalyzes TMB oxidation to generate a colorimetric signal read at 450 nm (with long-wavelength correction 620–650 nm). The assay is designed for sensitive, specific quantitation of trace HSA in biological products (natural and recombinant) and is intended for research use only.
Technical Specifications
| Parameter | Details |
|---|---|
| Format / Scale | 96 tests per kit (8 × 12 well strips) |
| Assay type | One-step sandwich ELISA (simultaneous addition of sample and HRP-conjugated detection antibody) |
| Linear range | 0.25–16 ng/mL |
| Linearity (fit) | R² ≥ 0.990 (typical calibration R² = 0.99998) |
| Lower Limit of Quantitation (LLOQ) | 0.25 ng/mL |
| Typical calibration model / equation | 4-parameter logistic (4PL): y = (A - D) / [1 + (x/C)^B] + D; example parameters A=5.91069, B=-1.06512, C=20.56331, D=0.00881, R²=0.99998 |
| Specificity / Cross-reactivity | No cross-reactivity reported with fetal bovine serum (FBS) and horse serum |
| Sample types | In-process samples, harvested bulk, drug substance, drug product; recommended validation for other biological matrices |
| Recommended sample pH | pH 6.0–8.0 |
| Reading wavelength | 450 nm (reference/correction 620–650 nm) |
| Incubation conditions (example) | Sample reaction: ~2 hours at room temperature on shaker (500–600 rpm); TMB development: 10 min at room temperature |
Features
- One-step assay format: Simultaneous addition of sample and HRP-conjugated detection antibody simplifies workflow and reduces hands-on time.
- High sensitivity: LLOQ of 0.25 ng/mL and linear range down to 0.25 ng/mL for trace-level HSA detection.
- Specific double-antibody sandwich: Polyclonal anti-HSA capture antibody with HRP-conjugated detection antibody provides high specificity for HSA.
- Ready-to-use pre-coated strips: Strips are pre-coated and vacuum-sealed with desiccant for convenience and reduced lot-to-lot handling.
- Quantitative output: 4-parameter logistic (4PL) calibration curve for accurate quantitation across the stated range.
Applications
- Quantitation of Human Serum Albumin (HSA) in in-process samples
- Measurement of HSA in harvested bulk (bioprocess samples)
- Quantitation of HSA in drug substance and drug product
- Detection of natural and recombinant HSA in research workflows
- Method validation and process monitoring in biomanufacturing research
Kit Contents
HSA Calibration Standard (PNB018)1 × 150 μL — refer to tube label; store at 2-8 °C; prepare fresh
Anti-HSA Microtiter Strips (PNA017)8 strips × 12 wells — pre-coated; vacuum bag with desiccant; store at 2-8 °C (unused strips: keep sealed with desiccant)
Diluent (PNE004)2 × 25 mL — store at 2-8 °C
Wash Buffer Concentrate (10×) (PNF001)1 × 25 mL — store at 2-8 °C; may crystallize at low temp (incubate at 37 °C to dissolve)
Anti-HSA:HRP (100×) (PNN012)1 × 120 μL — store at 2-8 °C; dilute 100× in Diluent immediately before use; prepare fresh
TMB Substrate (PND004)1 × 12 mL — sealed, protect from light, equilibrate to room temp before use; store at 2-8 °C
Stop Solution (PNI002, 1 M HCl)1 × 6 mL — corrosive (1 M HCl); store at 2-8 °C; handle with goggles and appropriate PPE
Sealing Film (PNK001)3 pieces — room temperature (cover plate during incubation to prevent evaporation)
* Total: 96 tests/Kit | Method: One-step sandwich ELISA (double-antibody, HRP/TMB colorimetric)
Attention
• For Research Use Only (not for clinical or diagnostic use).
• Store entire kit at 2–8 °C; check expiration dates on labels.
• Opened microtiter strips: store sealed with desiccant at 2–8 °C; stable up to 90 days.
• Prepare Anti-HSA:HRP (1×) freshly by 100× dilution in Diluent immediately before use; avoid repeated freeze-thaw.
• TMB substrate must be colorless before use; discard if colored. Protect from light.
• Stop Solution is 1 M HCl — corrosive. Avoid contact with skin, eyes, and clothing; use appropriate PPE.
• Avoid sodium azide (NaN3) in samples or reagents — it will deactivate HRP and cause underestimation.
• Recommended sample pH between 6.0 and 8.0; outside this range may cause abnormal results.
• Avoid drying wells before substrate addition and avoid excessive foaming during dilutions.
• Do not mix reagents from different kit lot numbers.
• Use sterile, disposable tips and reservoirs. Minimum recommended pipetting volume: 5 μL.
• Complete plate reading within 30 minutes after termination.
• If Wash Buffer Concentrate or Diluent is cloudy or contains precipitate, heat at 37 °C until clear.
Quality Management & Certifications
Quality System
Download QMSQMS (ISO, GMP)
Download CertificateQuality Advantages
View ReportQuality Control Process
Download ProcessTechnical Resources & Downloads
Frequently Asked Questions (FAQ)
Q1: What is the assay range and sensitivity (LLOQ) of the kit?
The assay linear range is 0.25–16 ng/mL with a reported LLOQ of 0.25 ng/mL. Typical calibration shows R² ≥ 0.990 (example R² = 0.99998).
Q2: What sample types can be tested with this kit and are validations required?
Intended for in-process samples, harvested bulk, drug substance and drug product. For other biological matrices, a method validation is recommended to verify sample suitability and recovery.
Q3: How long does the assay take to run?
Typical workflow requires a ~2 hour sample incubation at room temperature plus ~10 minutes for TMB development and additional wash/handling steps; overall time is less than 3 hours.
Q4: How should critical reagents be stored and handled?
Store kit at 2–8 °C. Prepare Anti-HSA:HRP fresh by 100× dilution in Diluent before each assay. Keep TMB protected from light and ensure it is colorless before use. Keep unused strips sealed with desiccant.
Research Use Only
✔
Research Use Only (RUO) — Not intended for clinical or diagnostic use. – This product is intended for laboratory research purposes only and not for clinical or regulatory diagnostic use.
✔
Not intended for use in USDA or FDA regulated diagnostic testing or official compliance testing.
When can I expect my order to ship?
Most orders are filled and shipped within 2-3 business days from the time they are received.
Our standard shipping usually take 2-5 days.
We also provide express shippping for time-sensitive deliveries.
Email contact@biofargo.com if you have any requirements.
