THE ENVIRONMENTAL TECHNOLOGY VERIFICATION
PROGRAM
xvEPA
U.S. Environmental Protection Agency
ETV Verification Statement
TECHNOLOGY TYPE: QUALITATIVE SPOT TEST KIT
APPLICATION: LEAD-BASED PAINT DETECTION
TECHNOLOGY NAME: LeadPaintCheck
COMPANY: Industrial Test Systems, Inc.
ADDRESS: 1875 Langston Street PHONE: 800.861.9712
Rock Hill, SC 29730
WEBSITE: http:// www.LeadPaintCheck.com
E-MAIL: its@sensafe.com
The U.S. Environmental Protection Agency (EPA) supports the Environmental Technology Verification (ETV)
Program to facilitate the deployment of innovative or improved environmental technologies through
performance verification and dissemination of information. The goal of the ETV Program is to further
environmental protection by accelerating the acceptance and use of improved and cost-effective technologies.
ETV seeks to achieve this goal by providing high-quality, peer-reviewed data on technology performance to
those involved in the design, distribution, financing, permitting, purchase, and use of environmental
technologies. Information and ETV documents are available at www.epa.gov/etv.
ETV works in partnership with recognized standards and testing organizations, with stakeholder groups
(consisting of buyers, vendor organizations, and permitters), and with individual technology developers. The
program evaluates the performance of innovative technologies by developing test plans that are responsive to
the needs of stakeholders, conducting field and laboratory tests (as appropriate), collecting and analyzing data,
and preparing peer-reviewed reports. All evaluations are conducted according to rigorous quality assurance
(QA) protocols to ensure that data of known and adequate quality are generated and that the results are
defensible.
This verification test was conducted under the U.S. EPA through the ETV program. Testing was performed by
Battelle, which served as the verification organization. This verification test was conducted in response to the
call of the Renovation, Repair, and Painting (RRP) rule for an EPA evaluation and recognition program for test
kits that are candidates to meet the false positive and negative goals of this rule. Per the RRP rule, a test kit
should have a demonstrated probability (with 95% confidence) of a false negative response less than or equal to
5% of the time for paint containing lead at or above the regulated level, 1.0 mg/cm2 and a demonstrated
probability (with 95% confidence) of a false positive response less than or equal to 10% of the time for paint
containing lead below the regulated level, 1.0 mg/cm2. Battelle evaluated the performance of qualitative spot
test kits for lead in paint. This verification statement provides a summary of the test results for Industrial Test
Systems LeadPaintCheck test kit.
-------
TECHNOLOGY DESCRIPTION
Following is a description of the LeadPaintCheck test kit technology, based on information provided by the
vendor. The information provided below was not verified in this test.
LeadPaintCheck is a semi-quantitative test kit that can detect the presence or absence of lead in paint. To
evaluate a sample, a half-inch circle paint sample is collected, the paint sample is cut up in smaller pieces, and
then homogenized in the ACID-1 acid solution. Lead in the Homogenized Paint (HP) sample is solubilized as
Pb+2 by the acid. The HP sample is then diluted 1/500 (100 microliters [|oL] per 50 milliliters [mL] of water).
The procedure for measurement of lead in the diluted sample uses 4 mL of the HP extract, which are added to
the built-in photocell of the eXact® LEADQuick™ Photometer. The sample is zeroed, two drops of Pb-2
Buffer are added to make the solution mildly alkali, and an eXact® Strip Pb-3 is then dipped in the sample for
20 seconds. The PB-3 strip simultaneously adds a porphyrin colorimetric indicator and mixes the solution.
After one minute, the eXact® LEADQuick™ Photometer measures the optical density (color) as an absorbance
number (abs). The abs value will be dependent on the amount of lead that is present: the higher the abs value,
the higher the lead concentration in the sample. The test kit determines when lead levels are below 1.0 mg/cm2.
The test also identifies semi-quantitatively if the lead concentrations in the paint are 1, 1.5, 2, or 3 (and above)
mg/cm2.
The LeadPaintCheck Startup Kit is priced at $1999.99. The reagent replacement set is $99.99 for 50 tests.
After the initial Startup investment the cost per paint test is $2. The estimated time to run the test, which
includes the sampling, homogenizing, diluting, and testing time, is under 15 minutes per paint sample.
VERIFICATION TEST DESCRIPTION
This verification test of the LeadPaintCheck test kit was conducted January through June 2010 at the Battelle
laboratories in Columbus, Ohio. This timeframe included testing of the test kit and also completion of all ICP-
AES and QC analyses.
Qualitative spot test kits for lead in paint were evaluated against a range of lead concentrations in paint on
various substrates using performance evaluation materials (PEMs). PEMs were 3-inch by 3-inch square panels
of wood (pine and poplar), metal, dry wall, or plaster that were prepared by Battelle. Each PEM was coated with
either white lead (lead carbonate) or yellow lead (lead chromate) paint. The paint contained lead targeted at 0.3,
0.6, 1.0, 1.4, 2.0, and 6.0 mg/cm2. These lead concentrations were chosen with input from a stakeholder
technical panel based on criteria provided in EPA's lead Renovation, Repair, and Painting (RRP) rule and to
represent potential lead levels in homes. Paint containing no lead (0.0 mg/cm2) was also applied to each
substrate and tested.
Two different layers of paint were applied over the leaded paint. One was a primer designed for adhesion to
linseed oil-based paint and the second coat was a typical interior modern latex paint tinted to one of three
colors: white, red-orange, or grey-black. These colors were chosen by EPA, with input from a technical
stakeholder panel, based on the potential of certain colors to interfere or not with lead paint test kit operations.
The top-coat paint manufacturers' recommended application thickness was used. Two coats at the
recommended thickness were applied.
The LeadPaintCheck test kit for lead paint was operated by a technical and non-technical operator. The
technical operator was a Battelle staff member with laboratory experience who had been trained by the vendor
to operate the test kit. The same technical operator operated this test kit throughout testing. Because this lead
paint test kit is anticipated to be used by certified remodelers, renovators, and painters, it was also evaluated by
a non-technical operator. The non-technical operator was a certified renovator with little to no experience with
lead analysis. The non-technical operator was provided the instruction manual, demonstrational DVD, and
other materials typically provided by the vendor with the test kit for training. He then viewed the materials
himself to understand how to operate the test kit. He was also permitted to ask questions or clarifications of the
-------
vendor on the operation of the test kit. This scenario approximated the training renovators are expected to
receive under the RRP rule.
Tests were performed in duplicate on each PEM by each operator, technical and non-technical. Duplicates were
tested in succession by each operator on a given PEM. PEMs were analyzed blindly. Test kit operators were
not made aware of the paint type, lead level, or substrate of the PEM being tested. PEMs used for analysis
were marked with a non-identifying number. PEMs were not tested in any particular order. To determine
whether the substrate material affected the performance of the test kits, two unpainted PEMs of each substrate
were tested using each test kit, in the same manner as all other PEMs (i.e., per the test kit instructions). Three
PEMs at each lead level, substrate, and topcoat color were prepared for use in this test. Thus, a total of 468
painted PEMs were used in the verification test.
To confirm the lead level of each PEM used for testing, paint chip samples from each PEM were analyzed by a
National Lead Laboratory Accreditation Program (NLLAP) recognized laboratory, Schneider Laboratories, Inc.,
using inductively coupled plasma-atomic emission spectrometry (ICP-AES) as the reference method. The paint
chip samples for reference analyses were collected by Battelle according to a Battelle standard operating
procedure (SOP), which was based on ASTM El729. Lead levels determined through the reference analysis
were used for reporting and statistical analyses.
The LeadPaintCheck test kit was verified by evaluating the following parameters:
• False positive and negative rates - A false positive response was defined as a positive result when paint
with a lead concentration <0.8 mg/cm2 was present. A false negative response was defined as a negative
response when paint with a lead concentration >1.2 mg/cm2 was present. Consistent with the EPA's April
22, 2008 RRP rule, panels with lead levels between 0.8 and 1.0 mg/cm2 were not used in the false positive
analysis, and those with lead levels between 1.0 and 1.2 mg/cm2 were not used in the false negative
analysis.
• Precision- Measured by the reproducibility of responses for replicate samples within a group of PEMs.
Groups of PEMs evaluated for precision included lead concentrations and substrate material. Responses
were considered inconsistent if 25% or more of the replicates differed from the response of the other
samples in the same group of PEMs
• Sensitivity - The lowest detectable lead level by the test kit. This parameter was identified based on the
detection results across all PEM levels and was determined based on the lowest PEM lead level with
consistent (>75%) positive responses.
• Modeled Probability of Test Kit Response - Logistic regression models were used to determine the
probabilities of positive or negative responses of the test kit at the 95% confidence level, as a function of
lead concentration and other covariates, such as substrate type, lead paint type, operator type, and topcoat
color. In order to account for the uncertainty associated with measurement error of the PEMs, the final
multivariable model for each test kit was subjected to a simulation and extrapolation (SIMEX) analysis.
• Matrix Effects - Covariate adjusted logistic regression models were used to determine whether any of the
PEMs parameters (topcoat color, substrate, operator, or lead paint type) affected the performance of the test
kit. Type III Statistics and comparison of likelihoods from logistic regression models were used to
determine the statistical significance of these factors.
• Operational Factors - Ease of use, operator bias, helpfulness of manuals, technology cost, and
sustainability metrics such as volume and type of waste generated from the use of the test kit, toxicity of the
chemicals used, and energy consumption were noted and summarized.
QA oversight of verification testing was provided by Battelle and EPA. Battelle and EPA QA staff conducted
technical systems audits, and a data quality audit of at least 10% of the test data to ensure that data quality
requirements were met. This verification statement, the full report on which it is based, and the test/QA plan for
this verification test are available at www.epa.gov/etv/este.html.
-------
VERIFICATION RESULTS
False Positive/Negative Rates: The overall observed false negative rate for the LeadPaintCheck test kit on
PEMs with confirmed lead levels >1.2 mg/cm2 was 2% for the technical and 1% for the non-technical operator.
The overall observed false positive rate on PEMs with confirmed lead levels of < 0.8 mg/cm2 was 14% for the
technical operator and 16% for the non-technical operator.
Precision: The LeadPaintCheck test kit provided overall consistent responses (either positive or negative) for
both the technical and non-technical operator for all lead levels except 0.6 mg/cm2. At this level, responses
were consistently positive 40-64% of the time. Inconsistent results were also obtained for 1.0 mg/cm2 lead on
plaster PEMs, with positive results 74% of the time. Results for all other lead levels were highly consistent,
between 93-100% and 0-8%. Only the evaluation of metal PEMs returned consistent results for all lead levels
overall. Results for the non-technical operator showed fewer inconsistencies than those for the technical
operator.
Results from the LeadPaintCheck test kit indicated 100% precision in evaluating PEMs with no lead. Because
of the strong consistent results noted for the LeadPaintCheck test kit, the precision of this test kit was high
across both lead paint types. For white lead PEMs, the LeadPaintCheck test kit produced consistent responses
90% of the time. For yellow lead PEMs, the LeadPaintCheck test kit was precise 83% of the time.
Sensitivity: The overall sensitivity of the LeadPaintCheck test kit was at the 1.0 mg/cm2 lead level. The kit
provided consistent positive responses at 1.0 mg/cm2 across both operators and lead paint types in all cases
except for yellow lead PEMs evaluated by the technical operator. In this case, the lowest level for which the
test kit provided consistent positive responses was 1.4 mg/cm2.
Modeled Probability of Test Kit Response: The modeled probability curve results indicate that at 0.8 mg/cm2,
there was no substrate type where the upper prediction bound provided a false positive rate of <10%. At 1.2
mg/cm2, no false negative rates <5% were obtained for any substrates based on the lower prediction bound.
Matrix Effects: After controlling for the significant covariates, the likelihood of a positive test result is
positively and significantly associated with higher lead levels and metal and plaster substrates. It is not
significantly and positively associated with drywall and wood substrates.
Operational Factors: Both the technical and non-technical operator found the LeadPaintCheck test kit
instructions to be clear, informative, and easy to follow. The solutions used for different steps were easily
identifiable within the kit and the storage conditions of the reagents were readily marked. All reagents came
prepared and ready to use.
The LeadPaintCheck test kit as supplied for this verification test came with an eXact® LEADQuick™
Photometer, all necessary reagents (including the quality check standard and the photometer strips), a
homogenizer kit by Omni that included all components necessary to operate the homogenizer, a 500 mL
wash/squirt bottle, 15 mL plastic conical tubes with lids, 50 mL plastic conical tubes with lids, !/2 inch cork
bore, cork bore sharpener, 100 |oL pipette and associated disposable tips, % inch cork bore (for applications not
part of this verification test), scissors, forceps, rod and base to hold the homogenizer, small brush, funnel system
for paint chip collection, scalpel with blades, masking tape, and a cork bore remover. All of these components
approximate the LeadPaintCheck test kit startup kit, which supplied everything listed here in sufficient
quantities for 50 tests.
The HP sample solution, diluted HP sample solution, rinses for the photometer, eXact® Strip Pb-3 strips, and
pipette tips were produced as waste for a single test.
-------
The LeadPaintCheck test kit provided clear and user-friendly instructions, but required multiple steps.
Operation of the test kit took approximately 22 minutes for the technical operator and approximately 27 minutes
for the non-technical operator, not including clean-up time. The non-technical operator considered the
LeadPaintCheck test kit to be inconvenient for use. A regular power supply was needed for the operation of the
homogenizer. Four AAA batteries were needed for the operation of the eXact® LEADQuick™ Photometer.
Signed by: Sally Gutierrez - December 03, 2010
Sally Gutierrez Date
Director
National Risk Management Research Laboratory
Office of Research and Development
NOTICE: ETV verifications are based on an evaluation of technology performance under specific,
predetermined criteria and the appropriate quality assurance procedures. EPA and Battelle make no
expressed or implied warranties as to the performance of the technology and do not certify that a technology
will always operate as verified. The end user is solely responsible for complying with any and all applicable
federal, state, and local requirements. Mention of commercial product names does not imply endorsement.
U.S. Environmental Protection Agency
------- |