A549 HCP ELISA Kit

Name: A549 HCP ELISA Kit
SKU: DEIABL475
Rating: 5 (1 reviews)

Regulatory status: For research use only, not for use in diagnostic procedures.

COA

SDS

Datasheet

Summary

Sample

Biological products

Species Reactivity

Human

Detection Method

Sandwich-ELISA

Intended Use

This kit is intended for use in determining the presence of protein contamination from the human cell line A549 in products manufactured by recombinant expression in A549 host cells. The kit is for Research and Manufacturing Use Only and is not intended for diagnostic use in humans or animals.

Contents of Kit

No.	Components	Size	Storage Conditions
1	Anti-A549-HRP	1 × 12 mL	2-8°C
2	Anti-A549 coated microtiter strips	12 × 8 wells	2-8°C
3	A549 HCP Standards	6 × 1 mL/vial	2-8°C
4	Stop Solution	1 × 12 mL	2-8°C
5	TMB Substrate	1 × 12 mL	2-8°C
6	Wash Concentrate (20×)	1 × 50 mL	2-8°C

Storage

1. All reagents should be stored at 2°C to 8°C for stability until the expiration date printed on the kit.
2. After prolonged storage, you may notice a salt precipitate and/or yellowing of the wash concentrate. These changes will not impact assay performance. To dissolve the precipitate, mix the wash concentrate thoroughly and dilute as directed in the 'Reagent Preparation' section.
3. Reconstituted wash solution is stable until the expiration date of the kit.

Performance Characteristics

CD has qualified this assay by conventional criteria as indicated below. This qualification is generic in nature and is intended to supplement, but not replace certain user and product specific qualification and qualification, which should be performed by each laboratory. At a minimum each laboratory is urged to perform a spike and recovery study in their sample types. In addition, any of your samples types containing process derived HCPs within or above the analytical range of this assay should be evaluated for dilutional linearity to ensure that the assay is accurate and has sufficient antibody excess for your particular HCPs. Each laboratory and technician should also demonstrate competency in the assay by performing a precision study similar to that described below. A more detailed discussion of recommended user qualification protocols can be obtained by contacting our Technical Services Department or at our web site.
Hook Capacity
Increasing concentrations of HCPs greater than 200 ng/mL were assayed as unknowns. The hook capacity, defined as that concentration which will give an absorbance reading less than the 200 ng/mL standard was ~ 200 μg/mL.

Precision

Both intra (n=20 replicates) and inter-assay (n=5 assays) precision were determined on 3 pools with low (~9 ng/mL), medium (~25 ng/mL), and high concentrations (~75 ng/mL). The % CV is the standard deviation divided by the mean multiplied by 100.