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FDA Approved HIV tests for Information
For Information to users
1. OraQuick Rapid HIV-1/2 Antibody Test
2. Reveal G3 Rapid HIV-1 Antibody Test
3. Uni-Gold Recombigen HIV Test
4. Multispot HIV-1/HIV-2 Rapid Test
5. Clearview HIV 1/2 Stat Pak
6. Clearview Complete HIV 1/2
http://www.cdc.gov/hiv/topics/testing/resources/factsheets/rt-lab.htm
1. OraQuick Rapid HIV-1/2 Antibody Test
2. Reveal G3 Rapid HIV-1 Antibody Test
3. Uni-Gold Recombigen HIV Test
4. Multispot HIV-1/HIV-2 Rapid Test
5. Clearview HIV 1/2 Stat Pak
6. Clearview Complete HIV 1/2
http://www.cdc.gov/hiv/topics/testing/resources/factsheets/rt-lab.htm
PCR-RNA tests (NAT) are not FDA approved for diagnostic use. The are approved for as supplemental use in conjunction with antibody tests.
messed up on the cut and past on my first post resd the second post people this info is off the labcorp website
Human Immunodeficiency Virus 1/O/2 (HIV-1/O/2) Antibody With Reflex to Nucleic Acid Testing (NAT)
The presence of HIV RNA in an HIV antibody-negative sample may be due to the presence of acute HIV infection prior to seroconversion. Repeat HIV antibody and Western blot confirmatory testing from a newly collected sample is needed to confirm the diagnosis of HIV. In a recent study, the interval from nucleic acid detection to first antibody reactivity ranged from 6 to 42 days with a median interval of 11.5 days. The NAT test has been FDA approved for the screening of plasma products but is not approved for HIV clinical diagnostics. The result should not be used as a definitive diagnosis of HIV infection without confirmation by HIV antibody and Western blot from a subsequent blood draw.
This test uses recombinant antigen sources and detects antibodies by specific immune binding and subsequent chemiluminescent reaction (ICMA technology). Sensitivity and specificity of this assay are 100% and 99.9%, respectively. Sera which are repeatedly reactive in two out of three tests are subject to confirmatory testing by the Western blot method. Some individuals may be initially reactive by the preliminary test and negative or indeterminate by Western blot. This may be caused by other viral antibodies or autoantibodies which cross react with the viral antigens, although this is extremely rare. The addition of nucleic acid testing (NAT) to HIV antibody testing algorithms significantly increases the detection of acute HIV cases and identifies highly contagious individuals, providing an HIV public health prevention targeting opportunity. Because acute infection, prior to seroconversion, is usually accompanied by high viral titers (10E5-10E7), it is possible to identify viral nucleic acid with sufficient sensitivity in pools of more than 100 samples per test. Pooled sample testing is the basis for widespread use of NAT testing of antibody-negative samples in the blood screening industry. The NAT assay has been optimized to detect 1-5 copies/mL of HIV viral RNA in a 512 specimen pool of HIV antibody-negative samples (the sensitivity per individual sample included in the pool is approximately 2000 copies/mL).
why do we not hear about this test it is FDA approved for the blood bank to use (blood bank has to know now ) it if i donate my blood and if you get blood transfusion this is the test they checked the blood you got
The result should not be used as a definitive diagnosis of HIV infection without confirmation by HIV antibody and Western blot from a subsequent blood draw. <------this is for false positve not for a negative
it is used in California and the wait is 2 days after exposer
The presence of HIV RNA in an HIV antibody-negative sample may be due to the presence of acute HIV infection prior to seroconversion. Repeat HIV antibody and Western blot confirmatory testing from a newly collected sample is needed to confirm the diagnosis of HIV. In a recent study, the interval from nucleic acid detection to first antibody reactivity ranged from 6 to 42 days with a median interval of 11.5 days. The NAT test has been FDA approved for the screening of plasma products but is not approved for HIV clinical diagnostics. The result should not be used as a definitive diagnosis of HIV infection without confirmation by HIV antibody and Western blot from a subsequent blood draw.
This test uses recombinant antigen sources and detects antibodies by specific immune binding and subsequent chemiluminescent reaction (ICMA technology). Sensitivity and specificity of this assay are 100% and 99.9%, respectively. Sera which are repeatedly reactive in two out of three tests are subject to confirmatory testing by the Western blot method. Some individuals may be initially reactive by the preliminary test and negative or indeterminate by Western blot. This may be caused by other viral antibodies or autoantibodies which cross react with the viral antigens, although this is extremely rare. The addition of nucleic acid testing (NAT) to HIV antibody testing algorithms significantly increases the detection of acute HIV cases and identifies highly contagious individuals, providing an HIV public health prevention targeting opportunity. Because acute infection, prior to seroconversion, is usually accompanied by high viral titers (10E5-10E7), it is possible to identify viral nucleic acid with sufficient sensitivity in pools of more than 100 samples per test. Pooled sample testing is the basis for widespread use of NAT testing of antibody-negative samples in the blood screening industry. The NAT assay has been optimized to detect 1-5 copies/mL of HIV viral RNA in a 512 specimen pool of HIV antibody-negative samples (the sensitivity per individual sample included in the pool is approximately 2000 copies/mL).
why do we not hear about this test it is FDA approved for the blood bank to use (blood bank has to know now ) it if i donate my blood and if you get blood transfusion this is the test they checked the blood you got
The result should not be used as a definitive diagnosis of HIV infection without confirmation by HIV antibody and Western blot from a subsequent blood draw. <------this is for false positve not for a negative
it is used in California and the wait is 2 days after exposer
Human ImmunodeficiencyImmunodeficiency disorders Virus 1/O/2 (HIV-1/O/2) Antibody With ReflexBabinski's reflex
Infantile reflexes
Moro reflex
Urge incontinence to Nucleic Acid Testing (NAT)
The presence of HIV RNA in an HIV antibody-negative sample may be due to the presence of acuteAcute hiv infection
Acute bilateral obstructive uropathy
Acute bronchitis
Acute cerebellar ataxia
Acute cholecystitis (gallstones)
Acute cytomegalovirus (cmv) infection
Acute gouty arthritis
Acute kidney failure
Acute lymphocytic leukemia (all)
Acute lymphocytic leukemia - photomicrograph
Acute pancreatitis HIV infection prior to seroconversion. Repeat HIV antibody and Western blot confirmatory testing from a newly collected sample is needed to confirm the diagnosis of HIV. In a recent study, the interval from nucleic acid detection to first antibody reactivity ranged from 6 to 42 days with a median interval of 11.5 days. The NAT test has been FDA approved for the screening of plasma products but is not approved for HIV clinical diagnostics. The result should not be used as a definitive diagnosis of HIV infection without confirmation by HIV antibody and Western blot from a subsequent blood draw.
This test uses recombinant antigen sources and detects antibodies by specific immune binding and subsequent chemiluminescent reaction (ICMA technology). Sensitivity and specificity of this assay are 100% and 99.9%, respectively. Sera which are repeatedly reactive in two out of three tests are subject to confirmatory testing by the Western blot method. Some individuals may be initially reactive by the preliminary test and negative or indeterminate by Western blot. This may be caused by other viral antibodies or autoantibodies which cross react with the viral antigens, although this is extremely rare. The addition of nucleic acid testing (NAT) to HIV antibody testing algorithms significantly increases the detection of acute HIV cases and identifies highly contagious individuals, providing an HIV public health prevention targeting opportunity. Because acute infection, prior to seroconversion, is usually accompanied by high viral titers (10E5-10E7), it is possible to identify viral nucleic acid with sufficient sensitivity in pools of more than 100 samples per test. Pooled sample testing is the basis for widespread use of NAT testing of antibody-negative samples in the blood screening industry. The NAT assay has been optimized to detect 1-5 copies/mL of HIV viral RNA in a 512 specimen pool of HIV antibody-negative samples (the sensitivity per individual sample included in the pool is approximately 2000 copies/mL).
why do we not hear about this test it is FDA approved for the blood bank
to use (blood bank has to know now ) it if i donate my blood and if you get blood transfusion this is the test they checked the blood you got
The result should not be used as a definitive diagnosis of HIV infection without confirmation by HIV antibody and Western blot from a subsequent blood draw. <------this is for false positve not for a negative
it is used in California and the wait is 2 days after exposer
Infantile reflexes
Moro reflex
Urge incontinence to Nucleic Acid Testing (NAT)
The presence of HIV RNA in an HIV antibody-negative sample may be due to the presence of acuteAcute hiv infection
Acute bilateral obstructive uropathy
Acute bronchitis
Acute cerebellar ataxia
Acute cholecystitis (gallstones)
Acute cytomegalovirus (cmv) infection
Acute gouty arthritis
Acute kidney failure
Acute lymphocytic leukemia (all)
Acute lymphocytic leukemia - photomicrograph
Acute pancreatitis HIV infection prior to seroconversion. Repeat HIV antibody and Western blot confirmatory testing from a newly collected sample is needed to confirm the diagnosis of HIV. In a recent study, the interval from nucleic acid detection to first antibody reactivity ranged from 6 to 42 days with a median interval of 11.5 days. The NAT test has been FDA approved for the screening of plasma products but is not approved for HIV clinical diagnostics. The result should not be used as a definitive diagnosis of HIV infection without confirmation by HIV antibody and Western blot from a subsequent blood draw.
This test uses recombinant antigen sources and detects antibodies by specific immune binding and subsequent chemiluminescent reaction (ICMA technology). Sensitivity and specificity of this assay are 100% and 99.9%, respectively. Sera which are repeatedly reactive in two out of three tests are subject to confirmatory testing by the Western blot method. Some individuals may be initially reactive by the preliminary test and negative or indeterminate by Western blot. This may be caused by other viral antibodies or autoantibodies which cross react with the viral antigens, although this is extremely rare. The addition of nucleic acid testing (NAT) to HIV antibody testing algorithms significantly increases the detection of acute HIV cases and identifies highly contagious individuals, providing an HIV public health prevention targeting opportunity. Because acute infection, prior to seroconversion, is usually accompanied by high viral titers (10E5-10E7), it is possible to identify viral nucleic acid with sufficient sensitivity in pools of more than 100 samples per test. Pooled sample testing is the basis for widespread use of NAT testing of antibody-negative samples in the blood screening industry. The NAT assay has been optimized to detect 1-5 copies/mL of HIV viral RNA in a 512 specimen pool of HIV antibody-negative samples (the sensitivity per individual sample included in the pool is approximately 2000 copies/mL).
why do we not hear about this test it is FDA approved for the blood bank
to use (blood bank has to know now ) it if i donate my blood and if you get blood transfusion this is the test they checked the blood you got
The result should not be used as a definitive diagnosis of HIV infection without confirmation by HIV antibody and Western blot from a subsequent blood draw. <------this is for false positve not for a negative
it is used in California and the wait is 2 days after exposer
No it's not, that is a list of rapid tests. PCR-RNA tests are not stand alone tests and have to be followed up with an antibody test.
"How long after a possible exposure should I wait to get tested for HIV?"
"Most HIV tests are antibody tests that measure the antibodies your body makes against HIV. It can take some time for the immune system to produce enough antibodies for the antibody test to detect, and this time period can vary from person to person. This time period is commonly referred to as the “window period.” Most people will develop detectable antibodies within 2 to 8 weeks (the average is 25 days). Even so, there is a chance that some individuals will take longer to develop detectable antibodies. Therefore, if the initial negative HIV test was conducted within the first 3 months after possible exposure, repeat testing should be considered >3 months after the exposure occurred to account for the possibility of a false-negative result. Ninety-seven percent of persons will develop antibodies in the first 3 months following the time of their infection. In very rare cases, it can take up to 6 months to develop antibodies to HIV.
Another type of test is an RNA test, which detects the HIV virus directly. The time between HIV infection and RNA detection is 9–11 days. These tests, which are more costly and used less often than antibody tests, are used in some parts of the United States." ( Reference CDC)
"Most HIV tests are antibody tests that measure the antibodies your body makes against HIV. It can take some time for the immune system to produce enough antibodies for the antibody test to detect, and this time period can vary from person to person. This time period is commonly referred to as the “window period.” Most people will develop detectable antibodies within 2 to 8 weeks (the average is 25 days). Even so, there is a chance that some individuals will take longer to develop detectable antibodies. Therefore, if the initial negative HIV test was conducted within the first 3 months after possible exposure, repeat testing should be considered >3 months after the exposure occurred to account for the possibility of a false-negative result. Ninety-seven percent of persons will develop antibodies in the first 3 months following the time of their infection. In very rare cases, it can take up to 6 months to develop antibodies to HIV.
Another type of test is an RNA test, which detects the HIV virus directly. The time between HIV infection and RNA detection is 9–11 days. These tests, which are more costly and used less often than antibody tests, are used in some parts of the United States." ( Reference CDC)
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