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All test results must be assessed by a qualified medical professional. Depending on the
analyte being assessed, high or low results may have medical consequences.
If the result reads > (greater than) or < (less than) or results are not as expected, always
repeat the test correctly with a new unused test strip. If a test result is displayed that is
not expected, consult the following table.
Message or Issue
Probable Cause
What to do
A displayed result reads
< (less than) a value.*
Result is below the measuring
range of the test.
Repeat the test. Run controls and confirm that
controls are in range.
A displayed result
reads > (greater than)
a value.*
Result is above the measuring
range of the test.
Repeat the test. Run controls and confirm that
controls are in range.
Display reads ”_ _
_ _” or N/A.*
Result is not available due to a
missing value from a calculation,
or a value is outside the
measuring range.
Repeat the test using a new, unused test
strip. Run controls and confirm that controls
are in range.
TRIGS TOO HIGH
LDL N/A
Lipid panel test triglycerides
result was 400 mg/dL (4.52
mmol/L) or greater.
No action needed. LDL will not be calculated
on samples with triglycerides of 400 mg/dL
(4.52 mmol/L) or greater.
Interpreting Results
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* See Measuring Range section of each test strip package insert for the measuring range for that specific test strip.
CLIA Information
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General CLIA Information (US Only)
(Please read before testing)
1. CLIA-waived. Each laboratory or testing site using the PTS Panels test strips MUST
have a CLIA Certificate of Waiver (or other CLIA operating license) before testing.
To obtain a Certificate of Waiver or any other type of laboratory license, call your
state health department or PTS Diagnostics at 1-877-870-5610 (Toll-free) or
+1-317-870-5610 for an application (form CMS 116).
2. Before you start testing, carefully read all instructions, including quality control.
Failure to follow instructions, including quality control instructions, will result in
high complexity rating and subject the facility to all applicable CLIA requirements
for high complexity testing. For complete information including performance,
please refer to the product-specific package insert and user guide. The glucose
and lipid panel test systems are currently CLIA waived. The original CLIA waiver
was under the analyzer name BioScanner Plus.
3. CLIA-waived for whole blood (fingerstick and venous EDTA or heparin)
testing only.
USA: Rx Only
