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Product Description
One-step, solid-phase sandwich Enzyme‑linked Immunosorbent Assay (ELISA) for quantitative detection of Trypsin-analog residuals in biological product preparations and process samples. The kit uses a sheep polyclonal capture antibody coated on microtiter strips and an HRP-conjugated sheep polyclonal anti-Trypsin-analog detection antibody added simultaneously with samples/standards. HRP catalyzes TMB oxidation producing a colorimetric signal read at 450 nm (with long-wavelength correction 620–650 nm). The kit is suitable for detecting non-animal origin recombinant fungal Trypsin-analog and related engineered enzyme reagents (examples: TrypLE™, Recombinant Trypsin, HyrTryp™). Intended for research use only (not for clinical diagnostics).
Technical Specifications
| Parameter | Details |
|---|---|
| Package | 96 tests/Kit (8-well × 12 strips) |
| Assay format | One-step sandwich ELISA; simultaneous addition of HRP-conjugated detection antibody and samples/standards |
| Linearity & Range | 0.16–10.24 ng/mL, R² > 0.990 |
| Lower Limit of Quantification (LLOQ) | 0.16 ng/mL |
| Typical read wavelengths | Primary: 450 nm; Reference/long-wavelength correction: 620–650 nm |
| Incubation conditions | Sample incubation on thermoshaker: 600 rpm, 2 hours at room temperature; TMB substrate incubation: 15 minutes at room temperature |
| Calibration standards | Seven-point serial dilution prepared from supplied Calibration Standard to produce ST1–ST7: 10.24, 5.12, 2.56, 1.28, 0.64, 0.32, 0.16 ng/mL (NCS = 0) |
| Specificity | No cross-reactivity with common engineered cell lines (MDCK, Vero, HEK293, E. coli, P. pastoris, Sf9) and no cross-reactivity with recombinant human, bovine or porcine trypsin |
| Recommended sample pH | pH 6.5–8.5 (outside this range may cause abnormal results) |
| Recommended long-term sample storage | -70 °C to avoid degradation |
| Wash buffer preparation | Wash Buffer Concentrate (10×) dilute 1:10 with ultra-pure water (prepare fresh) |
Features
- High sensitivity: LLOQ 0.16 ng/mL allows sensitive quantification of residual Trypsin-analog.
- High specificity: No cross-reactivity to common cell lines or to recombinant human/bovine/porcine trypsin; designed for fungal recombinant Trypsin-analog detection.
- Ready-to-use coated strips: Microtiter strips pre-coated with affinity-purified sheep anti-Trypsin-analog polyclonal antibody for consistent capture.
- One-step workflow: Simultaneous addition of HRP-conjugated detection antibody and samples/standards simplifies procedure and reduces hands-on time.
- Quantitative output: Dose–response curve (4-parameter logistic) provides quantitative concentration values; compatible with standard curve software.
Applications
- Detection and quantification of residual Trypsin-analog in cell harvest solutions
- In-process monitoring during biologics production
- Analysis of drug substance and drug product for residual enzyme
- Quality control and method validation for products using Trypsin-analog (e.g., TrypLE™, Recombinant Trypsin, HyrTryp™)
Kit Contents
Trypsin-analog Calibration Standard (PNB009)1 × 100 μL; store at 2-8 °C (solution should be clear/transparent); prepare fresh dilutions before use
Anti-Trypsin-analog Microtiter Strips (PNA009)8-well × 12 strips; strips pre-coated and supplied in vacuum bag with desiccant; store sealed at 2-8 °C
Diluent (PNE005)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 temperature—dissolve at 37 °C before use; dilute 1:10 with ultra-pure water
Anti-Trypsin-analog:HRP (100×) (PNN003)1 × 140 μL; sheep polyclonal antibody conjugated to HRP; store at 2-8 °C; dilute 100× in Diluent immediately before use; centrifuge briefly before use
TMB Substrate (PND002)1 × 12 mL; store at 2-8 °C; equilibrate to room temperature 20 min before use; protect from light
Stop Solution (PNI002)1 × 6 mL; 1 M HCl; store at 2-8 °C; handle with care (avoid contact with eyes/skin/clothing)
Sealing Film (PNK001)3 pieces; store at 2-8 °C
* Total: 96 tests/Kit | Method: One-step sandwich ELISA
Attention
• For Research Use Only (not for clinical diagnostic use).
• Store kit components at 2-8 °C (including opened components); check expiration date on labels.
• Recommended sample pH: 6.5–8.5; samples outside this range may produce abnormal results.
• Avoid repeated freeze–thaw cycles of samples; long-term sample storage at -70 °C is recommended.
• Do not mix reagents from different lot numbers.
• Use fresh ultra‑pure water (do not exceed 37 °C) to prepare buffers; prepare Wash Buffer fresh.
• Avoid samples containing sodium azide (NaN3) as it inhibits HRP and will underestimate Trypsin-analog levels.
• TMB Substrate should be colorless; discard if colored. Protect TMB from light during incubation.
• Stop Solution is 1 M HCl—avoid contact with eyes, skin and clothing; handle with appropriate PPE.
• Centrifuge Anti-Trypsin-analog:HRP(100×) before dilution/use to avoid loss of reagent.
• Calibration Standard Solutions and HRP-conjugated antibody are recommended for single use due to stability.
• Minimum recommended pipetted 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: What is the assay dynamic range and sensitivity?
The assay linear range is 0.16–10.24 ng/mL with an LLOQ of 0.16 ng/mL (R² > 0.990).
Q2: What sample types can be tested and how should they be prepared?
Test samples include cell harvest solutions, in-process samples, drug substance and drug product. Samples must be clear and transparent; remove insoluble material by centrifugation or filtration. Dilute samples into Diluent to bring Trypsin-analog concentration within the calibration range. Avoid repeated freeze–thaw cycles.
Q3: Does the kit cross-react with other trypsins or cell components?
The kit shows no cross-reactivity with common engineered cell lines (MDCK, Vero, HEK293, E. coli, P. pastoris, Sf9) and no cross-reactivity with recombinant human, bovine or porcine trypsin.
Q4: How are calibration standards prepared?
Prepare a 100× dilute stock of the supplied Calibration Standard, then perform serial 1:1 dilutions to obtain ST1–ST7 at: 10.24, 5.12, 2.56, 1.28, 0.64, 0.32, 0.16 ng/mL. NCS (0) is Diluent only.
Research Use Only
✔
For Research Use Only (RUO). Not for clinical 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.
