Urine Protein and Urine Protein to Creatinine Ratio

Why Get Tested?
To detect excessive protein escaping into the urine, to help evaluate and monitor kidney function, and to detect kidney damage
When to Get Tested?
As part of a routine physical, as a follow-up to a previous positive urine protein test, or when you have a disorder or disease that affects the kidney
Sample Required?
A random or 24-hour urine sample; occasionally, a split 24-hour sample, with the night collection separated from the day collection.
How is it used?
Urine protein testing is used to detect protein in the urine, to help evaluate and monitor kidney function, and to help detect and diagnose early kidney damage and disease. A semi-quanititative test such as a dipstick urine protein is used to screen the general population for the presence of protein in the urine as part of a routine urinalysis. If slight to moderate amounts of protein are detected, then a repeat urinalysis and dipstick protein may be performed at a later time to see if there is still protein in the urine or if it has dropped back to undetectable levels. If there is a large amount of protein in the first sample and/or the protein persists in the second sample, then a 24-hour urine protein may be used as a follow-up test. Since the dipstick primarily measures albumin, the 24-hour urine protein test also may be ordered if a doctor suspects that proteins other than albumin are being released.

The urine protein test tells the doctor that protein is present in the urine, but it does not indicate which types are present or the cause of the proteinuria. When a doctor is investigating the reason, he also may order a serum and urine protein electrophoresis test to determine which proteins are being excreted and in what quantities. This is especially true if he suspects abnormal protein production, such as with multiple myeloma. He may order a Comprehensive Metabolic Panel (CMP) to look at albumin and total protein levels in the blood and to help evaluate kidney and liver function. If kidney disease or damage is suspected, he may also may imaging scans to evaluate the appearance of the organ.

A protein to creatinine ratio may be ordered on a random urine sample if a child shows evidence of significant and persistent protein in their urine with the dipstick urine test. Children, and sometimes adults, occasionally have some degree of transient proteinuria without apparent kidney dysfunction and may have a higher excretion of protein into their urine during the day than at night. The doctor may monitor their urine at intervals to see if the amount of proteinuria changes over time.

Either a 24-hour urine protein or a random protein to creatinine ratio may be used to monitor a patient with known kidney disease or damage. A dipstick urine protein and/or a protein to creatinine ratio may be used to screen patients on a regular basis when they are taking a medication that may affect their kidney function.

Total Protein and A/G Ratio : labtest

Why Get Tested?
As part of a general health checkup, to determine your nutritional status or to screen for certain liver and kidney disorders as well as other diseases
When to Get Tested?
When you have a routine physical exam or if you experience unexpected weight loss or fatigue or if your doctor thinks that you have symptoms of a liver or kidney disorder
Sample Required?
A blood sample drawn from a vein in your arm or by fingerstick (adults and children) or heelstick (newborns)

How is it used?
Total protein measurements can reflect nutritional status and may be used to screen for and help diagnose kidney disease, liver disease, and many other conditions. Sometimes conditions are first detected with routine testing before symptoms have begun to appear. If total protein is abnormal, further tests must be performed to identify which specific protein is abnormally low or high so that a specific diagnosis can be made.

5-HIAA : labtest

Why Get Tested?
To help diagnose and monitor treatment for a serotonin-secreting carcinoid tumor
When to Get Tested?
When you have symptoms suggestive of a carcinoid tumor such as flushing, diarrhea, and/or wheezing, and at intervals following treatment
Sample Required?
A 24-hour urine sample; rarely a random urine sample

How is it used?
5-HIAA may be ordered by itself or along with a blood serotonin level to help diagnose and monitor carcinoid tumors. A 24-hour urine sample is preferred for the 5-HIAA test because the metabolite level in the urine can vary during the day. A random urine sample is sometimes tested, usually along with a urine creatinine level, when a 24-hour sample is not feasible. The random sample is not as accurate, however, and if the excess 5-HIAA is released intermittently, then it may be missed.

17-Hydroxyprogesterone

Why Get Tested?
To screen for, detect, and monitor treatment for congenital adrenal hyperplasia (CAH); sometimes to help rule out other conditions
When to Get Tested?
As part of a routine newborn screen, when an infant has ambiguous genitalia, when a young female has hirsutism or other symptoms of virilization, when a male child has premature sexual development, and periodically to monitor CAH treatment
Sample Required?
A blood sample drawn from a vein in your arm or blood from a heelstick for an infant.

How is it used?
The 17-hydroxyprogesterone (17-OHP) test is routinely ordered as part of newborn screening in the United States to detect congenital adrenal hyperplasia (CAH), a group of inherited disorders caused by specific gene mutations and associated with cortisol-related enzyme deficiencies. About 90% of CAH cases are caused by a mutation in the CYP21A2 gene that leads to a 21-hydroxylase deficiency and to accumulation of 17-OHP in the blood.

Up to 75% of newborns affected by 21- hydroxylase deficiency CAH will also produce less aldosterone, a hormone that regulates the retention of salt. The loss of too much fluid and salt in the urine can lead to a life-threatening adrenal crisis also called "salt-wasting" crises.

The 17-OHP test may be used to screen for CAH before symptoms appear or confirm a CAH diagnosis in persons with symptoms. The newborn screen is so sensitive that there may be a significant number of false positive test results. Positive 17-OHP screening tests may be repeated, or other tests performed, such as androstenedione and testosterone. If a 17-OHP test is abnormal, then an ACTH stimulation test may be also be ordered as a follow-up test. Molecular genetic testing may be performed to detect CYP21A2 gene mutations that can cause the condition. A karyotype test may be ordered as a follow-up test to detect chromosome disorders and to help determine a baby's sex. Electrolytes may be ordered to measure the person's sodium and potassium levels.

Measurement of 17-OHP in the blood may also be used to aid in the diagnosis of CAH in older children and adults who may have a milder, "late-onset" form.

If someone is diagnosed with 21-hydroxylase deficiency, treatment will involve suppressing ACTH production and replacement of the deficient cortisol with glucocorticoid treatment. A 17-OHP test may be used periodically to monitor the effectiveness of this treatment.

A 17-OHP test may also sometimes be used, along with other hormone tests, to help rule out CAH in people who have similar symptoms, such as hirsutism and irregular periods. This includes women with suspected polycystic ovarian syndrome (PCOS) and infertility, and rarely those with suspected adrenal or ovarian cancers.

Test Procedure : Copper

Why Get Tested?
To measure the amount of copper in the blood, urine, or liver; to help diagnose and monitor Wilson’s disease; sometimes to identify copper deficiencies and excesses
When to Get Tested?
When you have jaundice, fatigue, abdominal pain, behavioral changes, tremors, or other symptoms that your doctor thinks may be due to Wilson’s disease or, rarely, to copper deficiency or excess; at intervals when you are being treated for a copper-related condition
Sample Required?
A blood sample drawn from a vein in your arm and/or a 24-hour urine sample; sometimes a liver biopsy sample.

How is it used?
Copper testing is primarily ordered to help diagnose Wilson’s disease. If a doctor suspects Wilson’s, then he would typically order a total and/or free (unbound) blood copper test along with a ceruloplasmin level. If these tests are abnormal or equivocal, then they may be followed by a 24-hour urine copper test to measure copper excretion and a hepatic (liver) copper test to evaluate copper storage. Genetic testing may also be performed to detect mutations in the ATP7B gene if Wilson’s disease is suspected. However, these tests have limited availability and are usually performed in special reference or research laboratories.

If a doctor suspects copper toxicity, copper deficiency, or a disorder that is inhibiting copper metabolism, then he may order blood and/or urine copper tests along with ceruloplasmin to help evaluate the patient’s condition. One or more copper tests may be ordered to help monitor the effectiveness of treatment for Wilson’s disease, copper excess, or copper deficiency.

MS in Clinical Research offered by US Universities

Colleges that offer MS in Clinical Research

Purdue University
Ohio State University
University of California
University of Cincinnati
University of Kentucky
Ferris State University

NOVAVAX Launches Phase I Clinical Trial To Evaluate Its Novel Vaccine Against Respiratory Syncytial Virus (RSV)

Novavax, Inc. (Nasdaq: NVAX) announced that it has begun patient enrollment in a Phase I clinical trial to assess the safety, immunogenicity and tolerability of a vaccine candidate against respiratory syncytial virus (RSV). In this blinded, placebo-controlled, escalating-dose study of healthy adults 18 to 49 years old, a total of 100 subjects will be allocated to four cohorts and randomized to receive vaccine treatment or saline placebo in a 4:1 ratio. It is expected that interim top-line data from the trial will be available in the third quarter of 2011.
Remarking on this key accomplishment for the Company, Dr. Rahul Singhvi, Novavax's President and CEO, said, "The launch of this trial is timely because there are no vaccines currently approved for RSV disease, which is the most important viral cause of lower respiratory tract infection in infants and children worldwide and is a major cause of respiratory illness in elderly adults. The initiation of the trial for this RSV vaccine candidate marks a key milestone for Novavax, as the Company now has a clinical candidate in a second major disease target in addition to influenza."

Novavax has evaluated its RSV vaccine candidate in well-accepted animal models of toxicity and disease and found it to be safe at all doses tested. Preclinical results have shown induction of neutralizing antibodies and protection from RSV challenge with no disease enhancement and no detection of disease in any of the animals immunized with the vaccine at any dose level tested. Novavax's vaccine uses highly purified recombinant particles of RSV-F fusion protein normally found in the virus.

About Respiratory Syncytial Virus

RSV is the most important viral cause of lower respiratory tract infection in infants and children worldwide. The global disease burden is estimated at 64 million cases and 160,000 deaths every year. RSV is the most common cause of bronchiolitis (inflammation of the small airways in the lung) and pneumonia in children under 1 year of age in the United States. Each year, 75,000 to 125,000 children in this age group are hospitalized due to RSV infection. Almost all children will have had an RSV infection by their second birthday. When infants and children are exposed to RSV for the first time, 25% to 40% of them have signs or symptoms of bronchiolitis or pneumonia, and 0.5% to 2% will require hospitalization. Most children hospitalized for RSV infection are under 6 months of age. Additionally, wheezing illnesses caused by RSV, particularly those severe enough to lead to hospitalization, are associated with an increased risk of asthma at school age.

It is also estimated that more than 8.5 million adults, including the elderly over age 65 years, are infected and 900,000 patients are hospitalized annually due to RSV infection in the United States and major European countries. In the United States alone there are 177,500 hospitalizations among high-risk adults resulting in annual medical costs exceeding $1 billion. There is currently no approved vaccine for the prevention of RSV.

Source: Novavax, Inc

Sodium Bicarbonate Injection-Recall Due to Particulates in Some Vials

American Regent and FDA notified healthcare professionals of the nationwide recall of  specific lots of Sodium Bicarbonate Injection, USP, 7.5% and 8.4%, 50 mL Single Dose Vials because some vials of these lots contain particulates. Potential adverse events after intravenous administration include damage to blood vessels in the lung, localized swelling, and granuloma formation.

RECOMMENDATION: Hospitals, infusion centers, clinics and other healthcare facilities should not use American Regent Inc., Sodium Bicarbonate Injection, USP, 7.5% and 8.4%, 50 mL Single Dose Vials with the lots  list in the firm press release for patient care and should immediately quarantine any product for return.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm