Very Early HIV and Hepatitis C RNA PCR Detection tests
Ultra early and exquisitely accurate HIV-1 (Groups M and O) RNA; HIV-2 RNA; and Hepatitis C RNA test now available from Freedomhealth.
To book this test for exposures just 10 days prior call us on 020 3432 5586 or +44(0)20 7637 1600 from outside the UK. The test costs £280 including consultation fee. Results take up to 5 WORKING days to be returned to us.
We are now able to perform an extremely accurate HIV and Hepatitis C RNA test from as early as 10 days after potential HIV or Hepatitis C exposure. The test has an accuracy of greater than 99% at this point and is absolutely ideal for quickly identifying or ruling out new HIV or Hepatitis C infection.
This time frame was previously unavailable but utilisation of of standard routine technology in a novel diagnostic style will facilitate very early diagnosis.
The technique utilises a fully automated system made by Roche and the testing method uses a technique called polymerase chain reaction (PCR) or NAAT (Nucleic Acid Amplification) to dtecet miniscule amounts of viral genetic material. The technique can be and is applied to bacterial diseases also.
The technique was invented in the early 1980’s by a Dr Kary Mullis, who later won the Nobel Prize for the invention of such an elegant molecular biological technique. Initially, the test was cumbersome and required intensive well-trained technicians to perform it. In addition, the cost of running the test, partly because of the numbers of personnel involved, was high.
Automation via the Roche Taq Multiplex device has enabled highly sensitive, highly specific and fully automated testing to be run on human blood with the early detection of HIV 1 and HIV 2 possible from 10 days post exposure; early detection of Hepatitis C from 6 or 7 days post exposure and also Hepatitis B virus from 20 days post exposure.
The technique has had most application in terms of screening the human blood supply from blood donors and has reduced the numbers of inadvertent contamination with HIV and Hepatitis C virus very considerably. The technique is alos employed in organ donation settings where organs to be donated need to be very quickly screned for HIV 1; HIV 2, Hepatitis C and Hepatitis B viruses.
Thinking laterally and working with The Doctors Laboratory (a major global referral laboratory in London and CPA, UKNEQUAS; WEQUAS; ISFG and EMON approved for quality, robustness and high standards) we have collaborated to apply the early HIV 1 and 2 and Hepatitis C test The process works as follows. We take a measured amount of blood sufficient to run the three NAAT tests for HIV-1 and HIV-2; Hepatitis C virus and Hepatitis B virus. We can also include syphilis IgG and IgM within that screen.
The test is performed using the Roche platform and runs on the “sample in, results out” technique which reduces chances of contamination of product etc to zero. Should a positive sample be produced the whole specimen is drilled down to identify the virus producing the positive result and further confirmatory tests are performed.
The outcome is a highly sensitive, highly accurate detection methodology for detection of the identifed viruses. The turnaround time is swift, taking a maximum of 5 working days.
This has great potential in terms of early identification of newly infected HIV positive patients and also to allow those who think they may have been infected to relax and enjoy considerable peace of mind.
The identification of patients newly infected with HIV is important because it presents several interventional opportunities. It allows for very early identification of newly infected HIV positive people which provides the opportunity to anticpate and if necessary terminate by the use of anti-retroviral drugs the seroconversion illness; to mitigate the chances of that infection being transmitted unknowingly onwards to another individual; possibly to alter the course of the HIV illness by allowing a very early intervention to limit immune system damage should early intervention at the very early stage be proved to be beneficial.
In the FDA Workshop on Implementation of Nucleic Acid Testing as long ago as 1999, a Dr Busch identified the well-known phrase, the “window period” as being of critical importance in identifying and targeting in terms of NAAT.
The window period for HIV 1 and Hepatitis C virus has to date depended very largely on the sensitivity of the HIV 1 and Hepatitis C antibody detection devices.
This was improved on for HIV by the introduction of parallel screening with HIV 1 p24 antigen which reduces the HIV 1 detection interval by a week or so. In Europe we have had this test, commonly referred to as the HIV DUO test or HIV COMBO test for many years. The FDA in the USA have finally approved the test this month. In symptomatic individuals the combination of HIV 1 antibodies and p24 antigen has successfully identified HIV positive individuals at 12 days post infection. Co-infection with Hepatitis C and HIV has presented a diagnostic conundrum with occasional delayed sero-conversion – a group referred to as “immuno-silent”.
Studies on blood taken sequentially and regularly from people in the evolving phases of HIV and Hepatitis C diseases have given valuable information on the window period and which markers appear at what stage. Dr Busch coined the phrase “the eclipse period” which I think is a very elegant way of describing the time between physical transfer of infection to a person and the time when current testing methodologies can identify the illnesses.
Almost invariably when a person has been exposed to HIV then by the time they have symptoms they are already in a “viraemic” phase where there is lots of virus detected.
With lots of virus comes lots of core viral proteins-referred to as p24 antigen and so the combined HIV-1 and HIV-1 P24 antigen test is virtually always positive in the symptomatic patient.
So coming back to Dr Busch and his “eclipse phase”, this is the time period we are interested in detecting and the blood and organ donation services across Europe and the USA have utilised highly sensitive NAT techniques to identify early infection to halt contamination of the transfusion blood supply and transplanted organs.
Use of Nucleic acid Amplification Testing or PCR will reduce the window period, currently contained in the “eclipse phase” as described above, and allow early identification of newly infected HIV positive and Hepatitis C positive individuals at 10 days post infection. Similarly, early identification of hepatitis B will be possible with reduction of the window period for this illness to 20 days.
To book an HIV and Hepatitis C Early Detection test please call us on 020 3432 5586