Interpretation of Results Disclaimer
: DNA Connexions is not a clinical diagnostic laboratory and cannot provide a diagnosis for disease and/or subsequent treatment. These
results are from DNA PCR testing, and
indicate the presence of disease-causing agents known to be transferred by ticks. A positive result indicates the presence of DNA
from B. burgdorferi and/or other tick
-transmitted organisms. A negative result only indicates the absence of detectable targeted organismal DNA in the submitted
specimen.
The information is supplied as a courtesy to health care providers to aide in an overall assessment. This information alone should not be used to diagnose and/or
treat
a health problem or disease. All reported results are intended for research purposes only and consultation with a qualified health care provider is required.
4685 Centennial Blvd.
Colorado Springs, CO 80919
Telephone: 888-843-5832
Fax: 719-548-8220
CLIA#: 06D2019763
TIN: 47-2642690
Lab Director: Robert McMullen, PhD Lab Manager: Leslie Douglas, PhD
Patient: Sample, Sally (1/27/1964)
Provider: Jane Doe, MD Test ID: 33524
Sample Collected Sample Received
01/03/2020
Sample Tested
01/09/2020
Test Reported
01/11/2020
01/01/2020
Sample type: Urine
Test performed by: L. Douglas
This test utilizes the polymerase chain reaction (PCR) technology to detect the presence of targeted microbial
DNA for the causative agent of Lyme disease and common tick-transmitted co-infections. Sensitivity of the
test is 1 to 10 microbes with a specificity exceeding 5 x 10
18
.
The highlighted microbes were detected in the submitted sample:
Borrelia burgdorferi F7
B.
bur
gdorferi Osp A
B. burgdorferi Osp B-NPS
B. burgdorferi Osp C
Babesia microt
i
B
abesia divergens
Babesia duncani
Bartonella bacilliformis
Bartonella henselae-NPS
Bartonella quintan
a
B
orrelia miyamotoi
Borrelia recurrentis
Ehrlichia chaffeensis-IND
Anaplasma phagocytophilium
NONE
Lyme Panel
Positive
A Positive result is indicated by the organism or gene being highlighted in yellow.
When our species-specific primer sets are designed, the expected size of the amplification product (in base pairs)
is known. As every patient sample, every positive control, and every negative control are run in duplicate, when a sample
produces an amplification product of the expected size on either, or both, of the assay runs, it is scored as a ‘positive’.
Non-Predicted Size (NPS)
A NPS result is indicated by the organism or gene being highlighted in yellow, followed by NPS.
When we see an aberrantly sized amplification product, we consider the following: These microbial genomes are
small, on the order of a million bp, and tend to reproduce quickly. If a mutation occurs within the genome, something
non-deleterious to the organism, the mutation will then be perpetuated in subsequent generations. If this mutation occurs
in our target amplification region, the size of the subsequent amplification product will change (small or larger). The
product size differential could possibly be due to mutation, degraded DNA, mutation of species, unspecified subspecies,
etc. We have found that the NPS are more commonly detected in individuals with long-term infections. To be scored as
an NPS, the product needs to be visualized on both runs of the sample. It is at the discretion of a qualified medical
provider to interpret NPS results.
Indeterminate (IND)
An Indeterminate result is indicated by the organism or gene being highlighted in yellow, followed by IND.
An Indeterminant result indicates that an amplification product was produced for a particular organism on the
panel. However, the amplification product was not the expected size and was only present on one test run of the sample.
The explanation for this is the same as the NPS, however the aberrant amplification product was only present on one test
run. It is at the discretion of a qualified medical provider to interpret IND results.
Interpretation of Results
