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The interferon-α modeling study

Gunn WJ, Komaroff AL, Bell DS, Connell DB, Levine SM, Cheney PR.
Inability of retroviral tests to identify persons with chronic fatigue syndrome, 1992.
Morbidity and Mortality Weekly Report, vol. 42, pages 183-190, 1993.

Summary

This report summarizes the results from a collaborative effort to examine the validity of using HTLV-II-like retroviral sequences as a method for identifying CFS cases. Blood specimens were obtained from 68 patients who were participants in four unrelated studies in New Jersey, North Carolina, and New York. Healthy controls were selected from the same geographic areas. Each control was also matched to each individual patient so that they not only came from the same area, but were also the same age, sex and race. The blood specimens from CFS cases and controls were coded (blinded) to prevent their identification by laboratory workers, and tested using two versions of the polymerase chain reaction (HTLV-II-like sequences), and lymphocyte culture was also performed for evidence of spuma virus. None of these tests was able to distinguish CFS cases from healthy controls.

Abstract

This reports results of a study conducted by private and academic investigators to detect evidence of retrovirus infection in CFS patients and controls. Blood samples were obtained from 68 case-patients from four study populations (New Jersey; Charlotte, NC; Lyndonville, NY) and from 68 controls selected from the same geographic area. Blood samples were sent to two laboratories that had developed retroviral tests based on previous reports. None of the assays could differentiate between case-patients and controls. Assays from one laboratory were positive for 50 to 59% of both cases and controls. Assays from the other laboratory were negative for 90% of case patients and 96% of controls. This was the first controlled blinded trial to examine the ability of retroviral tests to distinguish CFS case-patients from controls. The findings did not support the hypothesized association between infection with retroviruses and CFS and are consistent with negative findings from other studies assessing evidence of retroviral infection. On the basis of this and other studies no scientific basis exists for the use of retroviral testing to confirm the diagnosis of CFS. Diagnostic testing of patients with suspected CFS should be done solely to exclude other diagnoses.

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