Frequently Asked Questions
1. What are Verichem products used for?

2. What advantages are there to using Verichem Products?

3. Are Verichem Products suitable for my analyzer?

4. Does Verichem offer data reduction?

5. 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?

6. What is calibration verification and how often is it required?

7. What if my calibration verification fails?




1. What are Verichem products used for?

Verichem products are so cost effective and stable you may use them routinely in the clinical lab for:
 
  1. calibration verification
    •  accuracy determinations
    •  linearity studies
    •  reportable range verification
    •  determination of system sensitivity
  2. new instrument validation
  3. tracking normal range drift
  4. pre-proficiency testing
  5. post-maintenance performance evaluation
  6. system bias to the true value

2. 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.


3. 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).

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.

For a list of recommended Verichem products compatible with your analyzer click here.


4. Does Verichem offer data reduction?

Yes, Verichem has developed an easy-to-use free online data reduction service.  All Verichem tolerance limits are in agreement with CLIA specifications and pre-loaded in this program.  Once you have received your Verichem reference materials, you can contact customer service for access to the data reduction service.  Registering for the data reduction services can be done online with access delivered within a few days by filling out the registration form link or for faster service, by calling Verichem Customer Service at 1 800 552-5859.

In each case, Verichem will assign a unique lab number and password.  Using this information you will be able to log on to Verichem’s data reduction website at www.verichem-data-reduction.net/submit.  With access you can download the results spreadsheet, fill in your data and submit.  Your finished pdf reports are available to view and print instantaneously. 

Data Reduction Reports include:

Interpretation Guide   Best Line
Scatter Plot Accuracy Determination
Peer comparisons Grading
Linearity Overall Grade
Reportable Range  

5. 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.


6. What is calibration verification and how often is it required?

Calibration Verification is the testing of materials of known concentration in the same manner as patient specimens to assure the test system is accurately measuring samples throughout the reportable range, thereby proving calibration accuracy.

Calibration verification is to be performed for nonwaived (moderate and high complexity) tests. It must be performed every 6 months (or more frequently if specified in the test system's instructions) and whenever any of the following occur:

  • Change of reagents to new lot numbers, unless the laboratory can prove that changing reagent lot numbers does not affect calibration.  See CFR 493.1255
  • Major preventive maintenance or replacement of critical parts that may influence the test performance.
  • Control materials reflect unusual trends or shifts, or are outside the laboratory's acceptable limits, and other means of corrective action fail to identify and correct the problem.
  • The Laboratory determines that the system's reportable range for patient test results should be checked more frequently.

7. What if my calibration verification fails?

Repeat calibration verification procedure as follows:

  1. First, confirm that your calibrator set point is specifically intended for the reagent you are using and that your daily controls are within limits.
  2. Using a new bottle of reagent and freshly prepared (unopened) calibrator, repeat entire study.
  3. Check the dynamic range of your instrument and make sure you are not challenging the system outside this range.
  4. Highest point failure:  You can either delete the highest point that failed and use your next highest point as the upper limit of your reportable range, OR pool equal amounts of the two highest points and assay your new point. In this case, your target value for the new point will be the average of the two target values used. Verichem strongly recommends using Class A volumetric glassware for preparing dilutions.
  5. Low point failure:  Typically,  is not clinically significant.  The Laboratory Director is responsible for the decision to accept or reject the study.
  6. If your failure is in the mid level range, you can delete the rogue point as long as the remaining points are within specified limits.