Urine pregnancy test sensitivity and specificity,how to be pregnant and lose weight jogging,what is the likelihood of getting pregnant with precum,odds of getting pregnant with condom - You Shoud Know

We have blogged previously (here and here) about false negative results in qualitative point-of-care (POC) hCG devices due to high concentrations of hCG?cf in urine. However, only a few research laboratories quantify hCG?cf, so it is difficult for most clinical laboratories to determine which urine samples have high concentrations of this hCG variant. There are many unanswered questions about hCG?cf, including: How high do hCG?cf concentrations get during pregnancy? First, the most common way to detect early pregnancy is by measuring the hormone human chorionic gonadotropin (hCG).
Fourth, when the clinical sensitivity of an hCG test for diagnosing pregnancy is determined, it is usually determined as a function of the number of days relative to the expected day of the menstrual period (EMP). Testing urine samples for the presence or absence of hCG is commonly performed in hospitals and clinics for the rapid assessment of a woman's pregnancy status. Because of these limitations, in particular the risk of false negative results, I've often said that urine hCG testing is inappropriate in healthcare delivery settings.
At long last, a rapid, quantitative blood test for hCG is finally available in the US from Abbott Point of Care, Inc. We evaluated the test using whole blood and plasma (the sample types that were cleared for use) as well as serum.
After our study was published, we were frequently asked whether these devices actually performed poorly in clinical practice or if the results we observed only occurred in a controlled laboratory environment.
Based on the description in the MAUDE report, we subdivided the false negatives by potential cause.
The fact that false negative pregnancy test results occur relatively frequently in clinical practice was an important finding because it highlighted the limitations of currently available devices and emphasized that this problem is not limited to one or two devices. To decrease the occurrence of false negative pregnancy test results, contributions from multiple different groups will be required. In the past, we have blogged about false negative urine qualitative hCG tests in both point-of-care (POC) hospital devices and over-the-counter (OTC) devices due to the presence of high concentrations of hCGbcf. It is our understanding that the FDA is requiring device manufacturers to address this problem in any new devices going through the FDA approval process.
Recently, we were made aware of two manufacturers that had apparently modified their qualitative pregnancy devices: The Cen-Med Elite Plus One-Step Pregnancy Test (a hospital POC device) and the First Response Early Result OTC device (an over-the-counter device).
If you are interested in hCG, like we are, you might be interested in a recent paper, in Clinical Chemistry, by Dr. The first bioassay was described in 1927 by the German scientists Ascheim and Zondek who demonstrated ovarian stimulation in mice when they were injected with the urine from pregnant women. For further reading, another great reference for the history of the pregnancy test was created by the NIH library and can be found here.
Once received in the lab, a blood sample has to be centrifuged to separate the serum (the liquid part of the blood that is actually tested) from the blood cells.
Both of the above steps increase the amount of time needed to perform the test and report the result to the physician. Although many qualitative hCG tests used in health care settings can be used with either urine or serum, qualitative serum testing is impossible to perform at the point-of-care.
Using whole blood instead of serum or urine was a modification of the intended use of an FDA-approved test and as such was against the law without appropriate validation experiments.
Involving laboratory professionals to help identify solutions for clinical dilemmas involving laboratory tests is always a smart idea. A recent post on this blog described the inability of qualitative point-of-care (POC) hCG tests to detect hCG when it was present in urine or serum at a concentration that should, according to the test manufacturer, always be detected.
A false-negative result from a home pregnancy test can be initially disappointing if a pregnancy is desired or a temporary relief if it is not. A recent case report has been published that, like other reports, emphasizes the limitations of qualitative urine hCG testing.
As has been noted in this blog in the past (here and here), urine hCG testing is commonly performed in the health care setting because it is convenient. HCG Urine Pregnancy Test  The Strip format is a One-Step dipstick test designed for clinical and professional use. One Step HCG Urine Pregnancy TestHuman Chorionic gonadotropin (HCG) is a glycoprotein hormone secreted by the developing placenta shortly after fertilization. HCG Pregnancy Urine testOne step HCG Pregnancy Urine test is a self-performing immunoassay designed for the quanlitative determination of human chorionic gonadotropin(HCG) in urine for early detection pregnancy by visual.
HCG pregnancy urine test strip URS-10M 10 parasHCG pregnancy urine test strip on YIDA REAGENT STRIPS are ready to use upon removal from the bottle.


Human chorionic gonadotropin (HCG) is a hormone, produced by the developing placenta shortly after the conception and secreted into the urine.
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If an egg is fertilized, the developing embryo will attach to the lining of the uterus around 6-12 days after ovulation. Qualitative devices are those that can be purchased over-the-counter to detect hCG in urine. Blood tests for hCG are much more reliable but they take longer to produce results because of the time required for sample transport and processing by a centralized laboratory. Overall, the test works quite well in all sample types and is suitable for use in healthcare settings.
While this type of result indicates that hCG is present in the blood, not having an absolute concentration will be insufficiently informative in some clinical situations. This means that when a sample with an extremely high hCG concentration is tested, the result can be falsely decreased. The use of urine hCG testing to determine a woman's pregnancy status is fraught with difficulties and is known to cause harm to patients.
False negative pregnancy tests can result in undesirable outcomes (including loss of pregnancy) if inappropriate treatment is given. Rather, the fact that the vast majority of pregnancy test devices performed poorly in our study and were reported to generate false negative results in clinical practice indicates that this is a much larger problem. First, the FDA should insist that device manufacturers market devices that generate positive results in all pregnant women, including those with high urine concentrations of hCG?cf. It is our hope that a coordinated effort from the FDA, manufacturers, clinicians and laboratorians will eliminate that risk.
However, it is up to manufacturers if they want to voluntarily change their existing devices. Braunstein is one of the researchers that helped develop the first radioimmunoassay specific for hCG in the 1970's and is a leader in the field of hCG. This is because obtaining serum requires centrifugation of the whole blood and centrifugation can't practically be done outside of a laboratory. It is so wrong that two colleagues and I wrote to the journal that published the report to let them know it was a VBI. If reliable results are to be obtained and utilized for patient care decisions, clinical laboratory tests must be performed using validated methods (including the type of sample tested). Some examples: the likelihood of a blood clot in the lungs given a patient’s risk factors or the 30-day likelihood of a heart attack if a patient with chest pain is sent home. By contrast, a false-negative result in the health care setting can result in serious harm to the fetus if a patient who is assumed to not be preganant undergo interventions that are potentially harmul to the pregnancy. The case describes a young woman who required radioactive iodine therapy for Grave's disease.
However, the problems with urine hCG tests are so numerous (see here and here) that urine hCG testing should not be relied upon to determine a patient's pregnancy status.
Currently, this means that serum hCG tests should be used exclusively, in the health care setting, for this purpose. We doesn't provide my first pregnancy products or service, please contact them directly and verify their companies info carefully. We have exported to UK, Germany, Poland, Italy, Moldova, UAE, Honduras, Philippines, South Africa and so on. If you require further details regarding the transaction data, please contact the supplier directly. Are high hCG?cf concentrations associated with certain clinical symptoms or pathological conditions?
Most women estimate EMP by counting 28 days from the first day of the last menstrual period (LMP).
It provides the reliability of laboratory blood-based hCG testing but with the convenience of point-of-care testing.
Despite their problems, urine hCG testing won't be going away any time soon but the availability of a test that performs hCG blood tests close to the patient is a step in the right direction.


In a recent study evaluating the performance of devices used in a hospital setting, 9 of 11 devices were found to be susceptible to false negative results when used to test urine solutions containing hCG?cf concentrations observed in normal pregnancy. 91 different POC hCG devices were described from 14 manufacturers, including 10 of the 11 devices evaluated in our initial screening study. Second, clinicians at large hospitals should request that pregnancy testing be performed on serum using a quantitative assay, especially in patients with abdominal pain, vaginal bleeding or other symptoms that strongly suggest the patient might be pregnant. Hence we have urged manufacturers to modify their devices to eliminate false negatives due to hCGbcf.
However the modified devices gave faint or clear positive signals in the presence of the same hCG concentrations (see figure). To deviate from established protocols without guidance from laboratory professionals is a VBI. Interestingly, this conclusion is similar to the one my group suggested in regards to qualitative serum hCG testing. To rely on less sensitive tests and less accurate urine hCG tests is a disservice to our patients.
It adopts double antibody sandwich method detects the presence of human chorionic gonadotropin (hCG), which appears in urine very early during pregnancy. The ability to estimate the amount of hCG?cf in urine will allow many more laboratories to study the concentrations of this interesting hCG variant. If large amounts of fluids are ingested (think Big Gulp)  then urine concentrations will be more dilute.
This 28-day cycle includes the approximate 14 days between first day of menses and ovulation (called the follicular phase) and the approximate 14 days between ovulation and the day before the next menstrual period (called the luteal phase).
We also found 142 reports that were likely due to hCGbcf hook effect and ten (or 7%) of those were associated with adverse events, including delayed prenatal care, delayed treatment of ectopic pregnancy, performance of inappropriate imaging studies and even surgery leading to loss of pregnancy.
Today, pregnancy tests account for $228 million dollars in annual sales and take up considerable shelf space at retail stores with different brands and styles (see photo). That fact would likely not have been discovered had the physician relied on a qualitative urine hCG test.
This is why first morning urine samples are often recommended because this urine is usually the most concentrated of the day since people don’t tend to drink anything during the sleeping hours.
In addition to the reports documented on the FDA website, it is virtually certain that many more false negative results have occurred and have gone unreported to the FDA.
Lastly, laboratorians should work to decrease the time required to generate test results in order to make quantitative testing more appealing to clinicians. Judith Vaitukaitis, developed new antibodies that were specific to the hCG beta subunit that an hCG-specific assay was developed. Fortunately, the laboratory had performed a quantiative urine hCG test (note that quantitative hCG tests using urine may be performed by the lab but the results are reported as qualitative (e.g. The amount of water in blood is more regulated that that of urine and generally does not change, even after ingesting large amounts of liquid. Interestingly, we have shown that the devices used at home are often more sensitive than the devices used in the hospital!!  We have previously blogged about this topic. Studies have shown that most of the variation occurs in the follicular phase.Therefore, the most accurate way to estimate the EMP is by measuring 14 days from ovulation as estimated by detecting a dramatic rise in the concentration of luteinizing hormone (LH), commonly referred to as the LH surge. At institutions where urine point-of-care testing must be performed, laboratorians should evaluate all available options and select the device that provides an optimal combination of sensitivity and lack of susceptibility to interference caused by elevated concentrations of hCG?cf.
With this assay, they were able to detect pregnancy as early as 7.5 days after fertilization and they were able to develop reference intervals for serum during pregnancy. Quantitative hCG assays are performed using blood samples in laboratories and are much more analytically sensitive than qualitative assays. Our causes of hiv and aids is the number one best selling because it's quite comfortable and thin.
Therefore, quantitative assays will be able to detect pregnancy earlier than qualitative assays.



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