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Product Description
This solid-phase enzyme-linked immunosorbent assay (ELISA) employs a double-antibody sandwich format to quantify CHO PLBL-2 (Phospholipase B-like 2) protein in biological samples. A CHO PLBL-2-specific capture antibody is pre-coated on microtiter strips. Calibration standards and test samples are added and incubated, followed by a biotinylated detection antibody that binds CHO PLBL-2 to form a sandwich complex. Streptavidin–HRP (SA-HRP) is then added and, after washing, TMB substrate is used to generate a colorimetric signal (blue), which is stopped to produce a yellow product with maximum absorbance at 450 nm. Absorbance (450 nm, with 620–650 nm reference subtraction) correlates with CHO PLBL-2 concentration and sample concentrations are determined using a 4-parameter logistic (4-PL) calibration curve. The kit is supplied for research use only (RUO).
Technical Specifications
| Parameter | Details |
|---|---|
| Assay format | Solid-phase double-antibody sandwich ELISA |
| Kit size | 96 tests/Kit |
| Linearity & Range | 50–12,800 pg/mL, R2 ≥ 0.990 |
| Lower Limit of Quantitation (LLOQ) | 50 pg/mL |
| Specificity / Cross-reactivity | No cross-reactivity observed with Sf9 HCP, E. coli BL21 HCP and MDCK HCP |
| Typical calibration curve (4-PL) | 4-PL parameters: A = 5.33548; B = -1.02792; C = 26167.08880; D = -0.00074; R2 = 1.00000 |
| Plate reading | Absorbance measured at 450 nm with reference at 620–650 nm; read within 10 minutes after stopping |
| Recommended replicates | 2–3 replicates recommended per sample |
Features
- High sensitivity: LLOQ of 50 pg/mL and linear dynamic range up to 12,800 pg/mL.
- Double-antibody sandwich format: Specific capture antibody pre-coated on microtiter strips with biotinylated detection antibody and SA-HRP for robust signal generation.
- Ready-to-use components: Pre-coated strips and concentrated conjugates provided; most reagents diluted immediately prior to use for convenience.
- Validated specificity: No observed cross-reactivity with tested non-CHO host cell protein sources (Sf9, E. coli BL21, MDCK).
- 96-test throughput: Kit configured for 96 tests (8 × 12 strips), suitable for routine testing and method validation.
Applications
- Detection and quantitation of CHO PLBL-2 protein (HCP) in CHO cell culture supernatant
- Analysis of in-process samples and harvested bulk from CHO processes
- Testing of drug substance and drug product for CHO PLBL-2 content
- Method validation and process development monitoring for biologics expressed in CHO systems
Kit Contents
CHO PLBL-2 Calibration Standard (lyophilized)Lyophilized; reconstitute with 500 µL Reconstitution Solution; aliquot and store ≤ -18 °C, avoid freeze-thaw
Anti-CHO PLBL-2 Microtiter Strips (pre-coated)Sealed in bag with desiccant; store at 2-8 °C; after opening keep in bag with desiccant (up to 90 days)
Reconstitution Solution (1.5 mL)Room temperature equilibration before use; store per kit storage (2-8 °C)
Diluent (2 × 25 mL)Store at 2-8 °C; use for standard and conjugate dilutions
Wash Buffer Concentrate (10×) (2 × 25 mL)Store at 2-8 °C; dilute 1:10 with ultra-pure water before use
Anti-CHO PLBL-2: Biotinylated Conjugate (200×) (60 µL)Store at 2-8 °C; centrifuge before use; dilute 200× with Diluent fresh on day of assay
Streptavidin-HRP (100×) (140 µL)Store at 2-8 °C; centrifuge before use; dilute 100× with Diluent fresh on day of assay
TMB Substrate (12 mL)Sealed, keep away from light; equilibrate to room temperature (25 ± 3 °C) for 20 min before use
Stop Solution (1 × 6 mL, 1 M HCl)Store at 2-8 °C; corrosive (1 M hydrochloric acid) — avoid direct contact
Sealing Film (3 pieces)Room temperature; use to cover strips during incubations
* Total: 96 tests/Kit | Method: ELISA (double-antibody sandwich)
Attention
• For Research Use Only (RUO). Not for clinical diagnostic use.
• Intended for use by qualified technicians only.
• Validate assay and sample suitability before routine testing.
• Use sterile, single-use consumables; recommended to wipe benches/equipment with 75% ethanol before and after use.
• Do not mix reagents from different lot numbers.
• Prepare 1×Biotinylated Conjugate and 1×Streptavidin-HRP fresh on the day of assay; calibrators and these working solutions are recommended for single use.
• Reconstituted calibration standard: aliquot and store ≤ -18 °C; avoid repeated freeze–thaw cycles.
• TMB Substrate must be colorless prior to use; discard if colored.
• Stop Solution is 1 M HCl — corrosive; avoid contact with eyes, skin, and clothing and follow appropriate safety procedures.
• Use fresh ultra-pure water (temperature should not exceed 37 °C).
• Avoid drying wells before substrate incubation; seal plate to prevent evaporation.
• Centrifuge concentrated conjugates before dilution to avoid loss of reagent.
• Minimum pipetting volumes and careful technique recommended (minimum recommended pipetting volume: 5 µL) to reduce pipetting error.
• Avoid samples containing sodium azide (NaN3) as it will inactivate HRP and cause underestimation of HCP levels.
Quality Management & Certifications
Quality System
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Download CertificateQuality Advantages
View ReportQuality Control Process
Download ProcessTechnical Resources & Downloads
Frequently Asked Questions (FAQ)
Q1: What is the assay detection range and LLOQ?
The assay linear range is 50–12,800 pg/mL with a reported LLOQ of 50 pg/mL.
Q2: What sample types are compatible with this kit and how should samples be prepared?
Compatible sample types include CHO cell culture supernatant, in-process samples, harvested bulk, drug substance and drug product. Samples should be clear and free of insoluble material (centrifuge or filter if necessary) and diluted into the calibration curve range using the provided diluent. Method validation is recommended to establish dilution series and matrix suitability.
Q3: How should reagents and the kit be stored?
Store the kit at 2–8 °C. Pre-coated strips should be kept sealed with desiccant at 2–8 °C (opened strips stable up to 90 days). Reconstituted calibration standard should be aliquoted and stored ≤ -18 °C and protected from repeated freeze–thaw cycles. Concentrated conjugates should be diluted fresh on the day of use.
Q4: Is there cross-reactivity with other host cell proteins?
No cross-reactivity was observed with the tested Sf9 HCP, E. coli BL21 HCP and MDCK HCP preparations per the kit data.
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.
