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dont they test the tests make sure they are 3 month window period before they tell people
Yes they do test the tests.
When a manufacturer introduces a new assay (test) the assays have to ungergo laboratory and clinical trials before they are approved. The Assays are tested against each other using various seroconversion panels ( a set of bloods from patients with known infection status), some with borderline (very weak) positives, some from patients who later seroconverted, some with co-infections (hep, chlamydia, TP etc) some with other conditions such as lymphoma, cancer etc, non HIV-1 B clade infections, HIV-2 infections.
In human trials the assays are used in parallel with existing assays on large cohorts of non-medical (i.e. those in for testing) patients and results sent to the approvals agency and the manufacturer.agency.
The knowledge that the vast majority of seroconversions occur within 3 months has been gained from clinical experience and limited studies on those presenting with ARS. That a minority of those presenting with ARS symptoms were actually experiencing HIV ARS (the Doctors on the expert forum say 1%) means those types of studies are too resource intense to be financially viable hence they are 'limited studies'.
The only way to truly test seroconversion time is to give a known innoculum at a known time to humans and test every day until seroconversion occurs and for obvious moral reasons that study will never be done. There are plenty datasets on simian seroconcersion time and I'd hazard that plenty enough is known on the similarities of simian and human to draw parallels.
The testing of assays appears to have no temporal element but most assays are three nines plus sensitivity and specificity anyway so there is an extremely strong correlation with those assays that have been used in seroconversion time studies. When testing the seroconversion panels some new assays identify positives that the assays they were tested against didn't indicating that they will identify infections earlier. The studies are all peer-reviewed and published so are traceable and repeatable.
You needn't have to worry about all this, it's all based on good science, they know what they are doing.
When a manufacturer introduces a new assay (test) the assays have to ungergo laboratory and clinical trials before they are approved. The Assays are tested against each other using various seroconversion panels ( a set of bloods from patients with known infection status), some with borderline (very weak) positives, some from patients who later seroconverted, some with co-infections (hep, chlamydia, TP etc) some with other conditions such as lymphoma, cancer etc, non HIV-1 B clade infections, HIV-2 infections.
In human trials the assays are used in parallel with existing assays on large cohorts of non-medical (i.e. those in for testing) patients and results sent to the approvals agency and the manufacturer.agency.
The knowledge that the vast majority of seroconversions occur within 3 months has been gained from clinical experience and limited studies on those presenting with ARS. That a minority of those presenting with ARS symptoms were actually experiencing HIV ARS (the Doctors on the expert forum say 1%) means those types of studies are too resource intense to be financially viable hence they are 'limited studies'.
The only way to truly test seroconversion time is to give a known innoculum at a known time to humans and test every day until seroconversion occurs and for obvious moral reasons that study will never be done. There are plenty datasets on simian seroconcersion time and I'd hazard that plenty enough is known on the similarities of simian and human to draw parallels.
The testing of assays appears to have no temporal element but most assays are three nines plus sensitivity and specificity anyway so there is an extremely strong correlation with those assays that have been used in seroconversion time studies. When testing the seroconversion panels some new assays identify positives that the assays they were tested against didn't indicating that they will identify infections earlier. The studies are all peer-reviewed and published so are traceable and repeatable.
You needn't have to worry about all this, it's all based on good science, they know what they are doing.
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