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January 1998 Volume 1, Number 3-4, Section 6

Laboratories That Offer the Ultra-sensitive PCR Test to Individuals

The Roche Ultra-sensitive test measures to 50 copies/ml, while the standard approved tests used commonly to measure viral load are the Roche Amplicor 400 copy test and the Chiron bDNA 500 copy test. Many individuals want to use the Ultrasensitive test but may not know where its available. Previously the test was only a research tool and not available to the general public. NATAP has assembled a list of labs that offer the test to treating physicians and individuals. Click on "Baseline Viral Load, Nadir of Response, How low should my viral load be?" for more discussion.

There are several points about the test results to bear in mind. The test is not yet FDA approved, although the manufacturer has applied for approval. Different labs may give you varying results because their methods can be different. Youshould use the same lab when retesting.

Each laboratory listed below has told me they validate their testing in house. You may want to speak to the lab yourself or ask your doctor to call to ask about their testing as there can be differences between labs in the reliability or accuracy of the results they obtain. You want a lab which has validated its testing adequately so the results will be reliable.

Test Results Variability. As with the standard viral load tests, although not common, test results can have variability because of several reasons. From 50 copies/ml and above you can see a 2-fold variability within a given lab just based on the performance of the procedures for the test. You can see a 2-3 fold biological variability due to your own changes within your body (fluctuations in immune system, colds, flus, or vaccines); as you may know you can get different CD4 counts from one day to the next. All together, it is estimated that a 5-fold variability may fall within normal test result variability.

Insurance reimbursement and cost. NATAP conducted a phone survey of the labs. Most labs said private insurers were paying for the test. New York State medicaid is not yet generally paying for the test, but Specialty Lab said they are receiving and accepting NYS medicaid reimbursement. Immediately below is a table for contact information. Some of the labs listed below may be more convenient for an individual than other labs based on location. If you are paying cash, pricing can vary between labs, so it is recommended to discuss cost with the lab; you can negotiate.

Some of the labs use the Roche test while other labs use a what they call a "home brew," where they have put together their own test. Based on my research, using the Roche test kit may produce more consistently reliable results but a "home brew" can be just as accurate and reliable. This is another question you may want to ask the lab and your doctor about. You can request the Roche test.

Some labs report it to you if they cannot find any virus at all. If you request, some labs will give you your absolute count (eg, 13 copies/ml). Remember, the accuracy of test results are most reliable when reported as either below or above 50 copies/ml. You can test the same sample today and not find any virus at all, but if you conduct the same test, in the same lab the next day you may find 20 copies/ml. So not finding virus does not mean virus is not present in the blood.

LabCorp and Quest are national with a number of locations. Consolidated is an independent lab and previously only performed viral load testing for drug research studies. It is based in LA but has an office in NYC for testing. You can call Richard Fung at Manhattan Medical Care (1780 Broadway, 12th floor; ph: 212 787-0900).

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