Redlabs is a licensed clinical and research laboratory located in Reno, Nevada. We are a specialty laboratory with a focus on the diagnosis and treatment of chronic immune disorders such as Chronic Fatigue Syndrome, Fibromiagia and Multiple Sclerosis. Although we offer many diagnostic tests our primary diagnostic tools are formed around the RNAse L antiviral pathway. Fragmentation of native RNAse L yields a 37 kilo dalton fragment, which is typically found in Chronic Fatigue Syndrome patients but not healthy individuals.

• RedLabs USA, Inc. Mission Statement
• Testing to aid in the diagnosis and treatment of Chronic Fatigue Syndrome
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Our Mission Statement

It is the mission of REDLABS U.S.A. to provide accurate and timely laboratory services to physicians for the diagnosis of chronic immune diseases and related maladies. Our continuing efforts focus on giving physicians the resources they need to effectively treat their patients while we search for an eventual cure. We welcome inquiries and suggestions that may enable us to better serve the medical community.

Quantitative Measurement of RNAse L Proteins: The Confirmatory Test to Aid in the Diagnosis and Treatment of Chronic Fatigue Syndrome

Chronic Fatigue Syndrome (CFS) is recognized as one of the most common chronic illnesses in the world. CFS is a complex disease syndrome of unknown etiology, afflicting people of all ages. Currently CFS is defined by its symptoms, the hallmark of which is chronic, debilitating fatigue of six months or more in duration.¹ In addition, patients suffer from a number of physical problems including myalgia, arthralgia, cognitive impairment, and sleep disorders.

Emergence of a Possible Diagnostic Marker

In 1995, Dr. Robert Suhadolnik and his co-workers at Temple University, Philadelphia, PA, detected a novel intracellular protein related to RNAse L, one of the interferon-inducible enzymes. These enzymes, which also include 2'-5' Oligoadenylate Synthetase, and double-stranded RNA dependent Protein Kinase, play a key role in protecting the cell from viral infection.^2,3 The novel protein was determined to have a molecular weight of approximately half of the native RNAse L (and is thus referred to as the Low Molecular Weight RNAse L or ‘LMW,' while the native RNAse L protein is referred to as the High Molecular Weight (HMW) species).

Working together with clinicians Daniel Peterson and Paul Cheney, Dr. Suhadolnik was able to demonstrate the presence of this LMW protein in a subset of patients with CFS.^4,5 His findings were independently confirmed by Dr. Bernard Lebleu, at the Institute for Genetic Molecular Medicine, Montpellier University, Montpellier, France, working together with clinician Kenny De Meirleir at the Free University of Brussels, Belgium.⁶

RNAse L Protein as a Clinical Assay

Redlabs USA offers a clinical assay for the RNAse L LMW protein. The assay is performed by 1) preparation of a cytoplasmic extract of the patient's peripheral blood mononuclear cells, 2) combination of this extract with a labeled probe that binds specifically to 2'-5'A-binding proteins such as RNAse L and the LMW species, 3) SDS-polyacrylamide gel electrophoresis, and 4) densitometry to determine the relative quantities of 2'-5'A-binding proteins (see Figure 1 below).

Results & Interpretation

Results are quantified with normal reference ranges provided. A numerical value is calculated by densitometry as "the amount of LMW protein present divided by the amount of native (HMW) RNAse L present" multiplied by a factor of 10 (or (LMW/HMW) x 10). The numerical cut-off values have been determined to be as follows:

Negative Ratio = <0.1 - 1.9               Positive Ratio = 2.0 or greater

The results of this test should be used in addition to all other relevant clinical data before making a diagnosis and/or a recommendation for treatment. Ranges are subject to change dependent on future data.

References

1. Holmes, G., et al., "Chronic Fatigue Syndrome: A Working Case Definition," Annals of Internal Medicine 108:387-389 (1988).
2. Suhadolnik, R., et al., "Changes in the 2-5A Synthetase/RNase L Antiviral Pathway in a Controlled Clinical Trial with Poly(I)-Poly(C12U) in Chronic Fatigue Syndrome," in vivo 8:599-604 (1994).
3. Suhadolnik, R., et al., "Upregulation of the 2'-5'A Synthetase/RNase L Antiviral Pathway Associated With Chronic Fatigue Syndrome," Clinical Infectious Disease 18:S96-S104 (1994).
4. Suhadolnik, R., et al., "Biochemical Evidence for a Novel Low Molecular Weight 2'-5'A-Dependent RNAse L in Chronic Fatigue Syndrome," J. Interferon & Cytokine Research 17:377-385 (1997).
5. Suhadolnik, R., et al., "Biochemical Dysregulation of the 2'5A Synthetase/RNase L Antiviral Defense Pathway in Chronic Fatigue Syndrome," J. Chronic Fatigue Syndrome 5:223-242 (1999).
6. De Meirleir, K., et al., "A Novel 2'-5'A Binding 37 kDa RNAse L as a Biochemical Marker for Chronic Fatigue Syndrome," American Journal of Medicine 108: 99-105 (2000).

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