What are Verichem products used for?

What advantages are there to using Verichem Products?

Are Verichem Products suitable for my analyzer?

Does Verichem offer data reduction?

Verichem's concentration range does not exactly match my manufacturers stated dynamic range. Do I need to use a calibration verification product that has ranges custom designed for my system?

 

What are Verichem products used for?
Verichem products are so cost effective and stable you may use them routinely in the clinical lab for:
	calibration verification •  accuracy determinations •  linearity studies •  reportable range verification •  determination of system sensitivity new instrument validation tracking normal range drift pre-proficiency testing post-maintenance performance evaluation system bias to the true value
What advantages are there to using Verichem Products?
There are major benefits to using Verichem Products.
1. Independent, Non-Consensus Value Assignment: Verichem's supreme quality and value accuracy is inherent in the root process of manufacturing. Verichem's primary focus is to produce the most accurate and stable gravimetric standards. However, some analyte concentrations, such as lipoprotein and enzymes, cannot be produced gravimetrically. These types of products we call “verifiers.” Verifiers may be either secondary standards or controls. Verichem's secondary lipoprotein and enzyme verifiers include lot-specific assigned values obtained from instrument manufacturers, direct measurement using clinical reference methods and/or direct measurement using a reference method calibrator. All Verichem primary standard concentrations are known by gravimetric procedure. This approach to value assignment is truly independent and eliminates the use of consensus, instrument-specific or reagent specific values. As a result, Verichem's protein based standards are used to determine the absolute accuracy of your clinical system in direct agreement with CLIA and peer agency requirements for verifier materials with known values . 2. Product Value and Stability: Compare kit size and expiry of Verichem products against all others. You will find that Verichem offers products with a low cost per mL and excellent long term stability. The benefit is continued use of the same kit, same lot, time after time, with less reordering. Our mission is to provide quality control products for the clinical laboratory with maximum accuracy, extended stability and a low cost per mL that can be used more routinely. We believe this approach will support and encourage universal clinical laboratory standardization, Verichem's ultimate goal. 3. Convenient and Ready to Use: All Verichem fluids are sold in liquid, ready to use format. Verichem concentration ranges are universal and designed to challenge the majority of clinical systems. Occasionally, you may need to dilute between concentration levels to obtain a lower value at the upper end of the assay range where linearity falls off. 4. Lot Certified Accuracy: A lot-specific Certificate of Analysis accompanies each gravimetric standard kit. The Certificate includes actual data from that lot when referenced to available Standard Reference Material obtained from the National Institute of Standards and Technology.
Are Verichem Products suitable for my analyzer?
Verichem Products are suitable for most diagnostic, wet chemistry analyzers and are not custom designed for any one analyzer. This is a cost-effective design strategy that allows us to produce larger lots and keep manufacturing costs to a minimum. In some cases, you may need to dilute between concentration levels to obtain a lower value at the upper end of the assay range where linearity falls off. Your verification range can be customized and extended for certain analytes by using the optional Level (F). Certain clinical systems, such as the Integra or Dimension, require electrolytes at physiological pH. Verichem will supply its Electrolyte Standard Kit, List Number 9200, at no charge for Dimension and Integra users. Verichem's knowledgeable technical support staff is ready to assist you in determining what products are right for your system. The Technical Support Department can be reached at 800-552-5859.
Does Verichem offer data reduction?
Yes. Verichem uses EP Evaluator™, the industry standard for calibration verification. Acceptance criteria are according to CLIA tolerances stated in 42CFR493, Section 493.931, Routine Chemistry. The cost of the data reduction is not built into the cost of the kits, so Verichem must charge a nominal fee of $2.00 per analyte report. Each report includes accuracy, reportable range verification, linearity and sensitivity according to CLIA requirements. The report is very comprehensive and includes a scatter plot, linearity plot, statistical analysis and experimental results, specifications and analytical claim. The data reduction price can be included with your kit purchase or you may send a separate purchase order. The data is sent to Verichem Customer Service and the reports are faxed, mailed or e-mailed to you within a few days. Verichem offers technical support if you have any questions about your report.
Verichem's concentration range does not exactly match my manufacturers stated dynamic range. Do I need to use a calibration verification product that has ranges custom designed for my system?
The patient results of most laboratories rarely covers the entire dynamic range stated by the system manufacturer. Therefore, it is not required by CLIA that you verify the manufacturer's stated range to an exact degree. You are required by CLIA and other peer agencies to “verify or establish the patient reportable range before reporting patient results.” CAP abides by the CLIA requirement stating “…the laboratory must demonstrate that the reportable range is comparable to that established by the manufacturer.” The key word of the requirement is “comparable.” Verichem's universal ranges are designed to establish the patient reportable range and verify the manufacturer's stated range of most clinical laboratory systems. Once calibration verification procedures are completed and you have determined your laboratory's reportable range, then all patient results within that range have been validated. This is true regardless of whether or not your reportable range closely matches the manufacturer's dynamic range. It may be unnecessary, tedious and costly to attempt to verify the stated range of the manufacturer using custom designed control material. Verichem's six level reference kits are designed to meet or exceed the reportable range of patients as well as manufacturer's stated ranges with four to six concentrations in agreement with CLIA requirements. In most cases the reportable range established using Verichem materials is very close to the manufacturers' dynamic range.