Why Not Just Buy a Kit?
Posted on Oct 28, 2020
Some kits are suitable, but will they fit your purpose? Should you use a kit for an ELISA, cell based assay, and enzyme assay or even a PCR project? Some kits are appropriate for certain applications. The advantage of a kit is that it typically costs less, since development is already completed by the vendor. However, some kits run over $1000/kit, and could be manufactured by MarinBio much more economically. Consideration as to which vendor manufactures the kit is important, as availability and reproducibility is essential and not all vendors offer high quality products with expected reproducibility from lot to lot. Since it is critical to have reproducible data for lot release assays and sample stability projects over years, vendor and kit selection as well as availability of the kit is extremely important. MarinBio has experience with many off-the-shelf kits and can determine whether they are suitable or whether an adaption or a better method should be developed.
Vendors often quote precision and accuracy but with analyte in buffer and at the midpoint of the quantitative range. Will it work in a complex matrix, like neat (undiluted) mouse or human serum? With complex matrices, there often are interference that affects the accuracy or provides a “hook” effect at higher concentrations of the drug. What sometimes works is the dilution of the drug/matrix to minimize the interference. Additionally, there are other reagents that can be employed to also minimize the interference. However, will the vendor take time to understand your needs and work with you to achieve your goals? Many of our clients need accuracy and precision at a low drug concentration (sensitivity limit). These types of studies and experiments can be performed at MarinBio in order to adapt the kit to a specific need.
Is a kit validated?
A kit can be validated by the vendor meaning that it has been shown to perform adequately under certain defined conditions. Do they match your conditions? More frequently, the commercial kits do not match the specific conditions required by our clients. Additionally, the vendor most probably has not validated the kit for your drug/matrix to satisfy FDA requirements for GLP or GMP standards? Marin Biologic will help you all the way. We are your scientists “next door”. We discuss the project with you, adapt to your methods, show you our experimental plans for your approval, and keep constantly in touch for meeting your timelines.
What about developing, validation a customized kit?
MarinBio scientists can develop a custom kit specifically suited to your needs. Selection of reagents to use in the kit will be from our audited vendors, knowing that the reagents are top quality and will be available long term. We will work with you to determine how long the assay kit will be used, (e.g. 3-5 years for stability studies) and will procure the critical reagents and consider their stability over the life of the project. The attention to detail that is important to our clients, such as specificity, accuracy, precision, sensitivity can be incorporated into the assay kit. MarinBio scientist designed, developed and produced a GMP ELISA kit (more than 2000 units produced) that yielded accurate and reproducible results in an amazing 90 minutes procedure time. We also successfully managed the distribution and training of hospital medical technologists in multiple hospital sites for a clinical trial, where the test results were critical to life and death decision within a 48 hour period of the patient entering the hospital.