In researching the validity of some of the blood tests to detect viruses, my conclusions have been indeterminate, much like the tests themselves. If you read the fine print on the package inserts for some of the serological tests for viruses, you will find a section called 'limitations' of the test.
In a few of them, they state that the tests are not intended or approved for screening the general population, but only 'high risk' groups. They also sometimes mention that the test is based on a 'presumptive diagnosis' or that a positive result 'suggests the presence' of the virus. Check out these links to read for yourself - and please note that I am simply questioning the validity of such tests. I am in no way trying to prove science wrong, but I feel the public has a right to 'informed consent' when undergoing any procedure and the package inserts are worth questioning.
First, a paragraph about blood tests from Online Medicine Tips (.com) :
"The blood test results are important because they allow a doctor to diagnose a disease or disorder. However, just the blood test is not used on its own. The doctor will also correlate the symptoms with the results." (read here)
The Inbios West Nile Detect (tm) IgM Capture Elisa Test states,on page one:
“Assay performance characteristics have not been established for testing cord blood, neonate, prenatal screening, general population screening without symptoms of meningoencephalitis or automated instruments. This assay is not FDA cleared or approved for testing blood or plasma donors.”
And under ‘Limitations’, it states: "All positive WN IgM Capture ELISA test results are presumptive and require confirmation by Plaque Reduction Neutralization Test or by using the latest CDC guideline for diagnosis of this disease. Testing should only be performed on patients with clinical symptoms of meningoencephalitis. This test is not intended for screening the general population. The positive predictive value depends on the likelihood of the virus being present."
From an HIV test kit package insert (Trinity Biotech Uni-Gold™ Recombigen® HIV):
“A Reactive result by Uni-GoldTM Recombigen® HIV suggests the presence of anti-HIV-1 antibodies in the specimen. Uni-GoldTM Recombigen® HIV is intended as an aid in the diagnosis of infection with HIV-1. AIDS and AIDS-related conditions are clinical symptoms and their diagnosis can only be established clinically.
“A person who has antibodies to HIV-1 is presumed to be infected with the virus, except that a person who has participated in an HIV vaccine study may develop antibodies to the vaccine and may or may not be infected with HIV. Clinical correlation is indicated with appropriate counseling, medical evaluation and possibly additional testing to decide whether a diagnosis of HIV infection is accurate."
From an HSV-2 test kit package insert (Trinity Biotech Captia™ HSV 2 Type Specific IgG):
“…the test is indicated for testing sexually active adults or expectant mothers for aiding in the presumptive diagnosis of HSV infection.”
“Testing should not be performed as a screening procedure for the general population. The predictive value of a positive or negative serologic result depends on the pretest likelihood of disease being present. Testing should only be done when clinical evidence suggests the diagnosis of disease.”
“The values obtained from this assay are intended for laboratory diagnosis only. Each treating physician must interpret the results in light of the patient's history, physical findings and other diagnostic procedures.”
In the package insert for the CervistaTM HPV HR test, under limitations:
1. The CervistaTM HPV HR test detects DNA of high-risk HPV types 16, 18, 31, 33, 35,
39, 45, 51, 52, 56, 58, 59, 66, and 68. This test does not detect DNA of HPV low-risk types (e.g. 6, 11, 42, 43, 44) since there is no clinical utility for testing of low-risk HPVtypes.18
10. Prevalence of HPV infection in a population may affect performance. Positive predictive values decrease when testing populations with low prevalence or individuals with no risk of infection.
So, there you have it - product literature straight from the package inserts of the above tests. I have seen many more, including H1N1 vaccination package inserts, which may or may not protect against that strain of flu (more to come).
Ask yourself why you have never seen the package inserts for the blood tests above or for a flu shot, while lining up at a public clinic. Ask your doctor or attending physician if you can read the information before the procedure is done and if they understand how to interpret the results or if they know exactly what is being injected into you.
Something stinks about these blood tests!!
Here are the links to the package inserts:
