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Product Description
The SHENTEK Vero HCP ELISA Kit is a one-step, solid-phase double-antibody sandwich ELISA for quantitation of host cell proteins (HCPs) derived from Vero cells in bioproducts (suitable for in-process samples, harvested bulk, drug substance and drug product produced by sonication cell lysis). The assay uses an affinity-purified sheep polyclonal capture antibody coated on microtiter strips and an HRP-conjugated sheep anti-Vero HCP detection antibody added simultaneously with standards or samples. HRP catalyzes TMB oxidation producing a colorimetric signal (read at 450 nm with correction 620–650 nm). HCP concentration is calculated from a 4-parameter logistic (4PL) calibration curve generated from supplied calibration standards.
Technical Specifications
| Parameter | Details |
|---|---|
| Assay format | One-step double-antibody sandwich ELISA |
| Intended use | Quantitation of Vero cell-derived host cell proteins (HCPs) in bioproducts; Research Use Only (RUO) |
| Package size / total reactions | 96 tests/Kit |
| Linearity & Range | 3–243 ng/mL, R² ≥ 0.990 |
| LLOQ | 3 ng/mL |
| Calibration standards (nominal concentrations) | ST1 243 ng/mL; ST2 81 ng/mL; ST3 27 ng/mL; ST4 9 ng/mL; ST5 3 ng/mL; ST6 1 ng/mL; NCS 0 ng/mL |
| Specificity / Cross-reactivity | No cross-reactivity reported with E. coli, P. pastoris and Sf9 cells |
| Detection wavelength | Read at 450 nm with correction 620–650 nm |
| Incubation times | Sample/antibody incubation: 3 hours at room temperature (600 rpm recommended); TMB substrate incubation: 10 minutes at room temperature |
| Wash conditions | 1× Wash Buffer, 340 µL per well, 5 washes |
| Working volumes | 100 µL 1×Anti-Vero:HRP per well + 100 µL sample or standard per well; TMB 100 µL/well; Stop solution 50 µL/well |
| Stop solution | 1 M HCl (corrosive) |
| Storage (kit & components) | Kit: 2–8 °C; Microtiter strips stored sealed with desiccant at 2–8 °C (up to 30 days after opening); Reconstituted Calibration Standard: -20 °C, freeze/thaw ≤3 cycles |
| Minimum recommended pipetting volume | Minimum volume recommended for accurate pipetting: 5 µL |
| Result calculation | 4-parameter logistic (4PL) fit of calibration curve; subtract NCS, use dilution factor to get sample concentration |
Features
- One-step assay design: Simultaneous addition of HRP-conjugated detection antibody with standards/samples simplifies workflow and reduces hands-on steps.
- High sensitivity: Lower limit of quantitation (LLOQ) of 3 ng/mL and linear range up to 243 ng/mL (R² ≥ 0.990).
- High antibody coverage (sheep polyclonal): Affinity-purified sheep polyclonal antibodies provide broad coverage of Vero-derived host cell proteins.
- Ready-to-use coated strips: Microtiter strips are pre-coated with capture antibody and packaged with desiccant for convenient setup.
- Complete kit components: Includes calibration standards, diluent, wash buffer concentrate, HRP-conjugated detection antibody, TMB substrate and stop solution for a full assay.
- Validated specificity: Manufacturer reports no cross-reactivity with common alternative host systems (E. coli, P. pastoris, Sf9).
Applications
- Quantitation of residual Vero cell host cell proteins (HCPs) in in-process samples
- Analysis of harvested bulk material
- Testing drug substance and drug product for Vero HCP content
- Assay development and validation in bioprocess monitoring and purification workflow optimization (research use)
Kit Contents
Vero HCP Calibration Standard (PNB012) — lyophilizedStore lyophilized; reconstitute with 500 µL Reconstitution Solution; reconstituted standard stored at -20 °C (freeze/thaw ≤3 cycles)
Anti-Vero HCP Microtiter Strips (PNA013) — 8-well × 12 stripsPre-coated strips stored in vacuum bag with desiccant at 2–8 °C; after opening store sealed with desiccant at 2–8 °C (up to 30 days)
Reconstitution Solution (PNC002) — 1 × 1.5 mL2–8 °C (used only to dissolve calibration standard)
Diluent (PNE004) — 2 × 25 mL2–8 °C (for dilution of standards, Anti-Vero:HRP and samples)
Wash Buffer Concentrate (10×) (PNF001) — 2 × 25 mL2–8 °C; dilute 10× with ultra-pure water before use; warm to 37 °C if crystallized
Anti-Vero:HRP (100×) (PNN007) — 1 × 120 µL2–8 °C; centrifuge before use; dilute 100× in Diluent to prepare 1× working solution; prepare fresh
TMB Substrate (PND005) — 1 × 12 mL2–8 °C, sealed and protected from light; equilibrate to RT before use; discard if colored
Stop Solution (PNI002) — 1 × 6 mL (1 M HCl)2–8 °C; handle as corrosive (avoid contact with eyes/skin/clothing)
Sealing Film (PNK001) — 3 piecesRoom temperature; use to cover plate during incubation to prevent evaporation
* Total: 96 tests/Kit | Method: ELISA (one-step double-antibody sandwich)
Attention
• For Research Use Only (not for clinical or diagnostic use).
• Store kit at 2–8 °C; check expiration date on labels.
• Avoid samples containing sodium azide (NaN3) — it will inactivate HRP and cause underestimation of HCP levels.
• Do not mix reagents from different lot numbers.
• Reconstituted calibration standards and Anti-Vero:HRP working solution are recommended for single use due to instability; prepare fresh before each experiment.
• TMB substrate should be colorless before use; discard and contact provider if colored.
• Stop solution is 1 M HCl — corrosive; avoid contact with eyes, skin, and clothing and follow appropriate safety procedures.
• Maintain sample pH between 6.5 and 8.5; values outside this range may cause abnormal results.
• Avoid repeated freeze–thaw cycles; for long-term storage of samples, -70 °C recommended.
• Complete plate reading within 30 minutes after termination.
• Use ultra-pure or sterile water for dilutions and ensure temperature does not exceed 37 °C when preparing solutions.
• Minimum recommended pipetting volume for accurate dilution: 5 µL.
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: Is this kit suitable for clinical diagnostic use?
No. This product is intended for Research Use Only (RUO) and is not for clinical or diagnostic use.
Q2: What is the assay sensitivity and dynamic range?
The assay linear range is 3–243 ng/mL with an LLOQ of 3 ng/mL and reported R² ≥ 0.990.
Q3: How should the kit and reconstituted standards be stored?
Store the complete kit at 2–8 °C. Reconstitute calibration standard per instructions and store reconstituted standard at -20 °C (limit freeze/thaw cycles to ≤3). Keep unused strips sealed with desiccant at 2–8 °C.
Q4: What are the recommended incubation times and reading parameters?
Incubate samples with 1× Anti-Vero:HRP for 3 hours at room temperature (600 rpm recommended). After washing, incubate with TMB for 10 minutes at room temperature. Read absorbance at 450 nm with correction wavelength 620–650 nm.
Research Use Only
✔
Research Use Only (RUO) – 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.
