Laboratories must conduct assay validations to ensure that accurate, reliable data is provided to physicians and patients, but it is not a routine task for most labs. Laboratory developed test (LDT) validation is a complex task, requiring specialized skills. Because most labs go through the validation process infrequently, in-house teams often have limited experience. If not carefully planned, mistakes in the validation process can lead to unexpected expenses and timelines that can stretch up to 12 months. For labs running on tighter margins than ever before, an efficient and cost-effective validation process is critical.
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Key Takeaways:
WHITE PAPER
• LDT validation can be a challenge even for
experienced clinical and research laboratories.
• Mistakes early in the validation process can
lead to delays, repeated testing, and added
costs.
• A validation consulting service ensures that
the process runs smoothly.
Laboratories must conduct assay validations to
ens
ure that accurate, reliable data is provided to
physicians and patients, but it is not a routine task
for most labs. Laboratory developed test (LDT)
validation is a complex task, requiring specialized
skills. Because most labs go through the validation
process infrequently, in-house teams often have
limited experience. If not carefully planned,
mistakes in the validation process can lead to
unexpected expenses and timelines that can
stretch up to 12 months. For labs running on tighter
margins than ever before, an ef?cient and
cost-effective validation process is critical.
The wrong plan will set validation
back before it begins
When adding a new assay, planning and
decision-making begin long before the validation
stage. The validation plan determines what
equipment, reagents, comparison samples, and
staff training will be needed to complete the work,
and failure to build a comprehensive plan will result
i
n a stressful, last-minute scramble to order
materials, provide training, or repeat studies.
Validation plans must be structured to account for
variable lead times for samples and supplies and
particular requirements by the accrediting agency.
Errors in panel selection, training oversights, and
misunderstood regulatory requirements can turn
what might have been a quick validation into a year-
long drain on your resources (Table 1). Having the
r
i
g
ht plan in place early can prevent costly and time-
consuming delays once the validation begins.
Error or
Adverse Event
Insuf?cient planning
Delay, repeated studies,
additional expense
Study plan mismatch to
accrediting agency
Additional work
Error in panel selection
Inef?ciency, loss of
pro?tability
Inadequate training
Repeated studies, additional
training time, safety issues,
loss of staff morale
Missing supplies
Delay, idle personnel, idle
equipment
Mismatched equipment Restart of project
Mismatched reagents Delay, additional expense
Incorrect, missing, or
inadequate reference
samples
Open ended delays,
unpredictable costs
Potential
Consequence
HOW TO ACHIEVE FAST,
COST-EFFECTIVE PCR ASSAY VALIDATION
The right validation partner can help you avoid costly mistakes
Table 1. Potential consequences of improper validation planning.
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Cost pressures are making many
panels unpro?table
Missing equipment or supplies can
result in signi?cant delays
Validation is not the time to discover that you have
insuf?cient thermocycler capacity or to realize that
you should have ordered a different sized block to
validate a new panel. It’s certainly not the time to
learn that you are missing reagents that are now on
backorder and may take weeks to arrive. When
materials are missing, the entire validation project
may come to a standstill.
Insuf?cient training results in
repeat work
The right skills and training are especially important
in the lab. Laboratory technicians must be experts
on assay protocols, biosafety, sample tracking,
The modern lab must run more tests on tighter
timelines than ever before, while reducing costs to
remain competitive in the increasingly
price-conscious medical sector. Medicare cuts have
strained all labs, but small- to mid-sized reference
labs now face the most severe cost pressures.? This
trend may intensify in the coming years, if Medicare
price updates continue to fail to keep pace with
in?ation.? Wages, materials costs, and overhead
may increase faster than Medicare
reimbursements, so labs must improve ef?ciency
and maximize pro?tability, by selecting focused,
easy-to-use test panels that make the most of
laboratory resources.
instrument calibration, and quality control. Add to
this the necessary expertise in data generation,
analysis, and interpretation, and the burdens of
training and skill assessment can become
overwhelming.? If technicians aren’t properly
trained to run assays, any work completed in the
validation may need to be repeated. It is critical,
therefore, to approach these processes with the
right resources and the best training plan.
Clinical sample sourcing is
cumbersome and prone to delay
Obtaining microbial reference strains and clinical
specimens for validation testing has never been
inexpensive or easy. Most validations require a
variety of pathogenic strains, stereotypes, or
antibiotic-resistant variants, plus positive and
negative clinical specimens, and requirements can
vary among accrediting agencies. When replicate
requirements are considered, it can be a challenge
to ?nd material in the necessary volumes.
Potentially cross-reactive samples and interfering
substances add to sample acquisition challenges.?
Sourcing validation samples from multiple
biobanks can become unmanageable and
validation can’t begin without the right samples.
A lab without ongoing support
may struggle with change
Laboratories must be able to adapt quickly to
increased throughput demands, staf?ng changes,
or to accommodate regulatory updates. And
sometimes changes make it necessary to
re-validate assays. In a busy reference laboratory,
resources may not be readily available to quickly
respond to changing needs, but labs must adapt
to remain compliant and competitive.
The solution: Partner with the right
validation consulting service
Not all laboratories have the time, resources, or
experience to conduct an independent validation.
By enlisting an experienced consulting service to
provide end-to-end validation support, labs can
avoid a potentially prolonged, stressful, and
expensive ordeal.
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1. Experienced team of specialists: Leverage a
team of experts that will guide you through a
regulatory-compliant LDT validation designed to
avoid the most common missteps made by
l
aboratories that add time and expense to the
validation process.
2. Tailored approach: Every laboratory has unique
capabilities. Applications scientists should be
available to perform a detailed assessment of
your current capabilities, create a validation plan
that meets regulatory requirements, and
consider your future operational needs.
3. Direct material sourcing: The right validation
consulting service will specify supply and
equipment needs appropriate for your panel and
validation requirements. An experienced
consultant can foresee potential issues with new
equipment and reagents, make sure that all
materials are in place before validation testing
begins, and help you avoid unexpected expenses
and delays.
4. Direct sample sourcing: A laboratory without the
right reference samples cannot correctly validate
an LDT assay. Thus, having a partner that can
supply reference strains and characterized
clinical samples that can be shipped directly to
your facility is bene?cial.
5. The right panels: Getting help in selecting the
right panel, from a partner with experience in the
market and that can provide high-level support
on billing and claim coding, is essential. A
focused panel translates into cost savings for the
facility, client, and patient.
6. Correct training: Consulting services should
include user-editable protocols, educational
materials, training videos, and comprehension
assessments that have been based on real
reference laboratory experience.
When choosing a validation
consulting service, keep in mind
the following key attributes:
The Bottom Line
Any successful business must acknowledge the
areas where guidance from a dedicated expert is
required for the best result. Most businesses, for
example, partner with an accountant to track their
?nances and provide tax advice. Existing personnel
may be excellent at math and recordkeeping, but
only a professional possesses the specialized
knowledge and experience necessary to perform
accounting tasks at peak ef?ciency, and in a way
that prevents future problems.
A similar, solutions-oriented partnership is available
to clinical and research labs in the form of PCR test
validation consulting services. The right test
validation consulting service will provide resources
and mentorship to guide clinical labs through the
challenges of validation.
Copyright © Streamline Scienti?c 2023
Two Perimeter Park South Suite 200W Birmingham, AL 35243 | 1.855.319.4459 | streamlinesci.com/contact-us
Copyright © Streamline Scienti?c 2023
Two Perimeter Park South Suite 200W Birmingham, AL 35243 | 1.855.319.4459 | streamlinesci.com/contact-us
Streamline Scienti?c’s PCR Test
Val
idation Consulting Service
Streamline Scienti?c’s ?eld applications specialists
have developed customized, regulatory-compliant
LDT validation plans for over 200 labs seeking CLIA
certi?cation or accreditation through COLA or CAP.
Streamline’s clients have completed validations in
an average of only 48 days, or 15 days if only one
panel is validated.
Streamline takes a white-glove approach to
validation consulting and pairs clients with a
dedicated applications specialist to partner with
them at each step. Processes have been re?ned in
Streamline’s in-house reference laboratory to
ensure that the right equipment, materials, and
training tools are provided for a successful
validation. Streamline’s applications specialists
remain available to clients to provide additional
training and support even after validation is
completed.
To learn more about our validation
services, please contact:
marketing@streamlinesci.com
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1. Nichols, James H. et al. What the Protecting Access to Medicare Act Means for Clinical
Laboratories. Clinical Chemistry. 1 Jun 2019. 65(6): 727–732. https://doi.org/10.1373/-
clinchem.2019.303255
2. Congressional Budget Of?ce. The Prices that Commercial Health Insurers and Medicare
Pay for Hospitals’ and Physicians’ Services. United States, 2022. Web Archive. https://w-
ww.cbo.gov/system/?les/2022-01/57422-medical-prices.pdf
3. Burd EM. Validation of laboratory-developed molecular assays for infectious diseases.
Clin Microbiol Rev. Jul 2010. 23(3):550-76. doi: 10.1128/CMR.00074-09. PMID: 20610823;
PMCID: PMC2901657.
References
Copyright © Streamline Scienti?c 2023
Two Perimeter Park South Suite 200W Birmingham, AL 35243 | 1.855.319.4459 | streamlinesci.com/contact-us
Copyright © Streamline Scienti?c 2023
Two Perimeter Park South Suite 200W Birmingham, AL 35243 | 1.855.319.4459 | streamlinesci.com/contact-us
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