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Dx Focus Mar 30, 2010: Clinical and Regulatory PCR and Nucleic Acid Testing News


Molecular Detection last week launched Detect-Ready MRSA, a real-time PCR-based diagnostic test for methicillin-resistant Staphylococcus aureus, in Germany, Austria, and Switzerland.

Molecular Detection, based in Wayne, Pa., said that Inverness Medical Deutschland will exclusively distribute the test in those countries.

The Detect-Ready MRSA kit is a qualitative, real-time PCR in vitro diagnostic test that directly detects MRSA nasal colonization to aid in the prevention and control of MRSA infections in hospitals and other health care settings, Molecular Detection said.

Test samples are obtained using nasal swabs, and the assay's pre-mixed reagents require only the addition of patient sample, the company said. The test provides results in less than three hours.

In addition, Detect-Ready MRSA kits do not require refrigeration, and are compatible with multiple RT-PCR platforms currently found in clinical laboratories, including the Roche LightCycler, Qiagen Rotor-Gene, and Cepheid SmartCycler.

This is Molecular Detection's first product, and the company said that it expects to ink additional distribution agreements and launch more RT-PCR-based diagnostics in coming months.

Diatherix Laboratories has added Diatherix GI, a gastrointestinal test panel, to its lineup of rapid response diagnostic tests, the company said this week.

Diatherix GI can detect and differentiate nine types of GI infections: Clostridium difficile; Clostridium difficile toxin B gene; Campylobacter jejuni; Escherichia coli strain 0157; Listeria monocytogenes; Salmonella enterica; Staphylococcus aureus; Vibrio cholerae; and Vibrio parahaemolyticus.

According to Diatherix, the test provides same-day results.

This is Diatherix's sixth diagnostic testing panel. All of Diatherix's tests use the company's proprietary technology, called target-enriched multiplex, or Tem, PCR. Diatherix said that Tem-PCR is the first diagnostic tool introduced to the clinical market that can identify multiple pathogens, detect co-infections, and determine genetic drug resistance in a single result.

Diatherix, located in the HudsonAlpha Institute for Biotechnology in Huntsville, Ala., operates as an independent high complexity CLIA-certified clinical laboratory.

Scientists affiliated with Milford Hospital in Milford, Conn., have developed and are now offering the first highly sensitive and specific DNA test for diagnosing early Lyme disease.

The test, developed by Connecticut physician Sin Hang Lee and colleagues, detects DNA from Borrelia burgdorferi, the spirochete that causes Lyme disease; then uses sequencing methods to validate the DNA.

The test is based on a method called LoTemp nested PCR, developed at Lee's company HiFi DNA. The LoTemp HiFi polymerase ready-to-use reaction mix comprises selected DNA polymerases, stabilizers, and melting reagents optimized for dsDNA denaturing at 85º C, which provides several advantages over traditional heat-resistant DNA polymerase kits, according to HiFi DNA's website.

Milford Hospital said that the test is designed to diagnose early Lyme disease before traditional serology lab tests become positive.

In a statement, the hospital also noted that a negative result from the DNA test does not rule out Lyme disease because spirochemia is transient and its time points in Lyme borreliosis vary from patient to patient. However, erroneous over-diagnoses of Lyme disease can lead to the unnecessary use of antibiotics, which can cause serious side effects in some patients.

Physicians at the Milford Hospital Emergency Center and Walk-in Urgent Care Center usually order traditional antibody testing along with the new DNA test for patients presenting with Lyme disease-like symptoms. Most insurance companies except Aetna will pay for the test, the hospital said.