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Kit Selection Checklist - Guidelines
Kit Selection Checklist Guideline
Guideline Number
Pur00-09-G
Effective Date
4 Sept
2009
Page
1 of 1
Supersedes
New
Author
Heidi Hanes
International QA/QC Coordinator
SMILE Comments: This document is provided as an example only. It must be revised to
accurately reflect your lab’s specific processes and/or specific protocol requirements. Users are
directed to countercheck facts when considering their use in other applications. If you have any
questions contact SMILE.
PPD Audit:
Question pertaining to instrument or test kits in the PPD audit can be found in Equipment,
Verification of Performance Specifications and Test and Control Articles Sections.
CAP Accreditation Checklist:
Questions pertaining to test kits can be found in the Laboratory General Checklist under Test
methods Validation section.
Background Information:
This checklist should provide basic questions that need to be addressed during the selection
and purchase of in the purchase of new test kits or reagents.
Resources/References
1. PPD Audit Shell.
2. College of American Pathologists (CAP) 2006. Commission on Laboratory
Accreditation, Laboratory Accreditation Program; Laboratory General Checklist Revised
4/6/2006.
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Kit Selection - SOP
Author(s), Name &
Title
Heidi Hanes BS, MT (ASCP) SH
Document
Number
Effective
Date
International QA/QC Coordinator
Pur00-09-SOP
4 Sept 2009
SMILE Comments: This document is provided as an example only. It must be revised to accurately
reflect your lab’s specific processes and/or specific protocol requirements. Users are directed to
countercheck facts when considering their use in other applications. If you have any questions contact
SMILE.
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Purpose
The purpose of this SOP is to outline the steps that should be taken when selecting kits for
either a new test or the replacement of a kit for a test already in use.
Procedure
I.
Initial kit evaluation steps
A. Things to consider prior to the introduction of a new test kit
1. What is the number of test to be performed per week? (At a
minimum should perform the test at least once a week in order for
staff to remain proficient.)
2. Will the introduction of the new test or kit involve additional training?
3. Is the technical expertise of the current staff sufficient for the
technical requirements of the new test kit?
4. Is there enough staff to perform testing if the kit requires accurate
timing or multiple steps? (If staff are required to multi-task may miss
critical timing of kit.)
5. Will additional equipment such as incubators, water baths or mixers
be required? Is the cost of additional equipment included in cost
analysis of the kit?
6. Is time needed for any reagent preparation, calibration, quality
control testing or system maintenance included in the cost of
analysis of the kit?
7. Ensure that additional QC materials or reagents purchased for
validation or startup are included in the kit cost analysis.
8. Consider the workload volume and compare it to the number of
tests per kit to make sure that appropriate kit size is selected.
9. Make sure that there is appropriate storage space for the new kits.
10. To evaluate the precision and accuracy of the kit check proficiency
test standard deviation and coefficient of variation to access the
precision and accuracy of the kit.
11. Are kit instructions written in different languages? Are languages
that are understood by the testing personnel included?
12. Is the amount of technical support provided appropriate? Are
troubleshooting guides and toll-free hot lines available?
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13. Consider all additional costs such as personnel costs, cost of
equipment and the cost of subscribing to a proficiency survey if an
additional one is required to perform kit testing.
II. Kit Selection
A. Make a list of available kits for the test in question using the following
sources:
1. Directories such as the Clinical Laboratory Reference published
annually by Medical Laboratory Observer
2. Manufacturers’ catalogs
B. Contact manufacturer of the selected kits for information. The information
obtained should include the kit configuration and components
C. If possible, get samples of selected kits to try out. See appendix A for a
worksheet to use in the evaluation of the kit.
D. Ask QA staff to obtain and review information about the performance of the
selected kits in proficiency survey programs.
E. Find out if the kit is US FDA approved? (If not FDA approved, validation of
the kit will be more involved. Ask the vendor for a K510 FDA approval letter.
The following website at the CDC can be used to check on this status http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/search.cfm)
F. Make sure that staff members performing the testing are included in the
evaluation of the kit.
III. Kit Comparison
A. Kits should be evaluated for the following factors.
1. Method Complexity.
a) How many steps are performed in kit?
b) Are any of the steps technically demanding steps? (Accurate
pipetting, etc.)
c) Are there critical timing steps?
d) How much operator time is needed?
e) Is the kit in a “Waived” test category?
2. Kit content.
a) Are reagents ready to use or do they require reconstitution?
b) Are kit bottles color coded to so that they can easily be
correctly identified .
c) Is there a user’s manual supplied with the kit?
d) Does the kit include a condensed, easy to read, instruction
card?
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e) Does the kit manual include a problem-solving section?
f) Does the kit manual have illustrations of the reactions or
clarification of any reactions?
g) Does the kit have a technical support toll-free phone number
in case of problems? Can technical help from a hotline be
accessed internationally?
3. Economic Considerations
a) What is the expiration range for the kit; will it out-date before
it can be used?
b) How much reagent is wasted if a kit outdates?
c) What are the storage requirements such as temperature,
humidity, and hazardous chemical components?
d) What type of kit parallel testing will be required?
4. Manufacturer support
a) Is the kit available locally or does it have to be imported?
b) Is there availability of quality control material for the kit?
c) Can control materials be found that are close to the decision
points of the test?
d) Does the manufacturer have a quality control or proficiency
testing program?
e) Can the kit be easily imported into the country?
5. Reliability of the kit.
a) What type of sensitivity and specificity does the kit have?
b) What type of performance does the kit have in proficiency
testing survey programs?(Proficiency testing can give you
incite to precision and accuracy-lack of bias-of the kit as long
as there is no matrix effect of the proficiency product.)
c) Are the reagents in the kits vulnerable to spoilage if not
stored properly either in transit or storage at the laboratory?
d) Are reagents packed in individual pouches?
6. Cost
a)
b)
c)
d)
How much does the kit cost?
Is Quality control included or is it an additional cost?
Is any proficiency testing included in the cost?
If kit requires refrigeration are there any unusually
temperature requirements?
e) What type of space requirement do you need for storage of
kits?
f) What type of waste can be expected with each kit?
Reference
Selecting Reagent Kits and Instruments, Daniel Ma Baer, M.D. and Richard E Belsey, M.D.,
University of Iowa Carver College of Medicine Continuing Education.
Appendix
Appendix A - Test kit selection worksheet
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