Frequently
Asked Questions
General Questions
Operations
Technical
Regulatory
References
The observer can only see in two dimensions, but tries to count targets that
rapidly move through three dimensions. Worse, when a microscopy sample is made
very thin to reduce that third dimension, motility data is distorted.
If you're asking this question, then your laboratory semen analysis protocol
is not yet supported by the sort of automation that has taken over other very
difficult tasks. In most laboratory tests today, the technologist is responsible
for preparation, operation/qualification of the system that does the analysis,
and then reporting.
Semen analysis is one of the very few lab tests that -- until now -- has required
estimates and interpretation by the technologist. Ifs easy to make estimates,
and to subjectively interpret, but to be accurate and consistent is almost impossible
when the targets move rapidly in three dimensions. That is why semen analysis
is so difficult, and why the SQA is so important.
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The semen sample is allowed to liquefy. The technician uses a disposable capillary
to pick up the sample, and then wipes it clean and inserts it into the SQA's
optical chamber.
A precision light beam passes through a clear capillary's known cross-section,
and is modulated/changed as sperm cells pass by. Obviously, they must be motile
to be detected. The resulting small changes in light are picked up by a fiber
optic sensor and measured by a phototransistor, or light sensor.
That signal is digitized and fed to a built-in computer, which uses a sophisticated
algorithm to analyze the data and generate the displayed results.
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The conventional World Health Organization numbers reflect total cell concentration,
percent motile cells, and percent normal morphology. These parameters are described
in the )WHO Manual, and later in this document as well.
In addition, the SQA generates the Sperm Motility Index (SMI), the Functional
Sperm Concentration (FSC), and the Motile Sperm Concentration (MSC).
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The system sees only motile (moving) cells, and the "machine language" of
the system is the Sperm Motility Index (SMI). It is provided
as the most direct indicator of male fertility. The Functional
Sperm Concentration (FSC) is the number of motile and
morphologically normal cells per milliliter. This datum
also directly correlates with impregnation potential.
The Motile Sperm Concentration (MSC) is just that; the number (in millions) of
motile cells per milliliter.
Researchers and most physicians who depend upon the SQA
just want to know "how
capable of impregnation is that sample,"
and ifs much easier to understand and use a single number
than a menu of parameters. For those who prefer to use
such a single number, the SQA provides the SMI, FSC,
and MSC.
Remember, in 99% of subfertile cases, there is no therapy or medication which
will improve the number of functional sperm cells. So, the researcher or physician
is best served by a verdict, not an analysis. These single-number parameters
are reliable verdicts, though many practitioners will continue to use the WHO
parameters.
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Under five minutes, assuming few interruptions, because this protocol involves
no judgment or subjective evaluation. The operator siznply loads the capillary,
cleans it, inserts it into the optical chamber, presses the TEST button, and
records the result.
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Assuming the sample is liquefied, it takes less than
ten seconds to load and clean the capillary, and 45 seconds
to complete the test. The internal computer displays
the result immediately. The answer, therefore, is "45
seconds from pressing the TEST button until the results
appear."
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It's excellent, compared to any standard. In research, SQA results have been
highly correlated with both CASA and (well-performed) microscopy. The SQA is
very consistent, while any other techniques are less so. If your lab does some
tests with microscopy and others with the SQA, all on the same samples, you will
see differences, but the range of results from microscopy will be far greater
than from the SQA.
To directly answer the question: the SQA is more accurate than microscopy by
a competent technologist, and less accurate than a $50k CASA system operated
by a trained andrologist.
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It's difficult.
If the instrument fails its own self-test (contaminated
optical chamber?) the internal computer won't permit
operation until if s cleaned. There are only three controls
on the panel, and if one pushes a "wrong" button;
the system won't let an error appear. If the sample hasn't
fully liquefied, it won't climb into the capillary and
the test cannot be performed.
However, if the capillary is dipped too far (contaminating
the light path), the result will be faulty. That's why
the technologist must visually ensure that the capillary
was properly filled and the outer surface cleaned.
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The internal cavity of the capillary measures about 0.03 cm x .5 cm, and
ifs about 1.5 cm deep, so the internal volume is about 0.0225 cc. That
varies, of course, with the height to which the fluid travels in the capillary.
Another variable is fluid that is lost to the cotton swab. Therefore, assuming
no special circumstances, a test uses about 0.03 ml.
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Very! Even if the concentration of viable cells is extremely
low (less than 500,000 motile cells per ml), the instrument
can provide an accurate reading of the impregnation potential
of the sample. Below that number, however, the statistical
correlations to the WHO parameters are no longer valid,
so the SQA's computer prevents their use. You can, however,
report something like "only 200,000 motile cells
per ml", which to a physician is confmnation of
grave subfertility. The SMI and TFSC can be reliably
used to compare subfertile samples, or to measure changes
due to treatment.
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One control is internal, the second external. Fixed/dead samples, or vinyl beads,
cannot be used because the system sees ONLY motile objects that disturb the light
path.
The instrument does internal self-tests similar to those performed by other computerized
medical equipment. When the SQA is first turned on it qualifies itself using
controls based upon the stability of a quartz crystal with the same accuracy
as a quality whst watch. On tum-on, built-in circuitry measures the ability of
the electro-optics to sense signals derived from that precision quartz crystal.
Also, the computer precisely measures the power required to maintain the necessary
brightness of the light source; if the optical path is obscured (dirt, dried
semen, etc.), the instrument will fail its self test and operation is not possible
until the optical path is cleaned. Actually, that test (for obscuration of the
optical path) is performed as the first part of each test.
There's a second test/control. A blank/empty capillary
is inserted into the optical chamber, and the READ button
is pressed. Obviously, the result should be 000 (unless
dust particles got in the way, when it may climb as high
as "002"
and still pass this test).
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This is simple. To demonstrate proficiency, the operator:
• Turns on the instrument and observes the built-in test result. Checks
the 'LOW' range of detection using an empty capillary.
• Allows a collected sample to liquefy, and then stirs/mixes the sample
to ensure homogeneity.
• Fills the capillary tube and uses the provided swab to remove any of
the sample from the exterior surface of the capillary.
• Inserts the capillary into the instrument, presses the 'TEST' button,
and records the results.
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With care, this just won't happen. If it does, however, cleaning is simple.
Each unit comes with "cleaning capillaries" that
are shaped like standard
capillaries but have a foam tip. A drop of alcohol is applied to the foam and
it is inserted and removed several times until the optical path is again clear
and the unit passes its self test.
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This is rare, since the SQA is a digital instrument built in accordance with
the highest quality control standards and with no moving parts. You are far more
likely to accidentally drop something on it than to have it fail due to circuitry
problems. If you're unlucky, the warranty is one year, and that covers all but
the most egregious abuse or damage. Thereafter, an annual service contract is
only ten percent of the purchase price.
But remember, the likeliest cause of problems is failure to clean the capillary.
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About 2,000 are in use by fertility clinics, sperm banks, ob/gyn office labs,
human fertility researchers, and clinical medical labs worldwide.
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Absolutely! The SQA has been heavily studied worldwide, by andrologists, physicians,
and scientists. In the U.S., Japan, Australia, Israel, France, and many other
countries, it has been found to be a highly consistent and reliable test. In
fact, researchers have found a direct correlation between SQA results and impregnation
potential of the specimen! Click here for a list of published articles.
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The honest answer is, "it can be difficult," because
the lab's technologists are usually calibrated against
a set of subjective standards, and the physicians have
become comfortable with the resulting numbers. If s easy
to determine which set of numbers are the more reliable:
have several technologists independently evaluate splits
from the same sample using microscopy and the SQA. After
adopting the SQA, your lab reports will be far more consistent
than they've ever been using microscopy. If s the job
of the lab manager to convey the new technology to the
physician constituency. Your distributor will help with
this when requested.
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Sure, but pick the right parameter: the Sperm Motility Index or the Fertile Sperm
Concentration. The WHO parameters (concentration, motility, morphology) can be
extracted only from undiluted, untreated, un-manipulated, never-frozen specimens.
The instrument sees only live/active cells, and extracts the rest of the information
from proven statistical correlations. Those correlations are built upon more
than 4,000 evaluations of fresh, undiluted, non-manipulated specimens.
Suppose you have a fresh specimen with 100M/ml concentration of which 50% are
motile. The instrument will produce these numbers, and you can trust them. But
diluting will affect the statistical correlations, so thereafter you should use
the SMI or FSC to determine impregnation potential.
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Once again, you must select the right parameter. Here's why.
Suppose you have a fresh, undiluted, never-frozen sample with 100M/ml concentration.
The SQA will produce the correct result, based upon observed motile cell concentration.
If that same sample were then frozen and thawed, there would still be 1OOM/ml
cell concentration, but the SQA would see far fewer live cells due to mortality
caused by the freezing/thawing process. Obviously, the statistical correlations
would be invalid. However, the SMI, FSC, or MSC (once again) can be counted on
to reliably defme impregnation potential of the sample after thawing.
Only a small percentage of men produce sperm cells that can be frozen with a
reasonable survival rate upon thawing. Sperm banks use the SQA to rapidly screen
donor candidates, avoiding the need for microscopy and subjective evaluations.
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20. What's inside that box?
It contains an optical chamber, computer, display, supporting circuitry,
and a power supply. The top of the box houses touch-controls. Other than the
switches, there are no moving parts.
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Yes. It is approved by all appropriate safety management and control agencies
(UL, CUL, CE, CSA, etc.).
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For current pricing, visit our Online Order
Form. For volume orders, please contact our sales department at sales@zdlinc.com or call us at
(800) 998-4567
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The SQA is manufactured in an ISO-9000 environment,
with fully traceable parts and procedures plus the full
documentation process expected in the manufacturing of
medical equipment. Every unit is then calibrated against
multiple "gold
standard"
instruments, and those "gold standards" are
checked against live semen.
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Considering the mission of the clinical laboratory, the Number One benefit of
the SQA is consistency, and therefore reliability of results! If the same sample
were simultaneously measured by multiple technologists using microscopy, there
would be substantially different results. But if the same samples were tested
by SQAS, the results would be consistent.
The second benefit is an overall reduction of lab labor cost. That's true because
the SQA takes far less time than microscopy, and as a "moderate"
test can be performed by any technician.
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You'd love that, but the answer (regrettably) is "no." There will occasionally
be a combination of patient, pathology, and physician where only microscopy will
answer certain questions. As one example, when the SQA indicates zeros, the IVF
question might be "are there any live cells at all?
That answer can only derive from microscopy. Sorry!
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U.S. Patent #4,176,953
U.S. FDA 510(k) K894949
Test System Code 40221
Analyte Code 5822
CDC/CLIA: Moderate Complexity
Manufacturing standards: CE, ISO-9001
Safety: UL, CUL, CE
CPT (MediCode billing): 89310
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