in vitro Diagnostics

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LyteStar™ Detection Kits

LyteStar™ Detection Kits are developed in compliance with ISO 13485 specifically for emerging needs that are not sufficiently addressed in the global marketplace.

 


LyteStar™ HCV Genotyping Kit

Accurate typing of Hepatitis C Virus (HCV) Genotypes 1, 1a, 1b, 2, 3, 4, 5, and 6 by real-time PCR.


LyteStar™ HIV-2 RT-PCR Kit

Specific detection of HIV-2 RNA (subtypes A and B) without cross-reactivity for HIV-1.


LyteStar™ Leptospira PCR Kit

Specific detection of pathogenic Leptospira species without cross-reactivity for non-pathogenic / saprophytic species.


LyteStar™ TB/NTM PCR Kit

For detection and differentiation of Mycobacterium tuberculosis complex and non-tuberculous mycobacteria (NTM).

Clinical Performance

The LyteStar™ TB/NTM Kit was clinically evaluated against mycobacteria culture in a study at the Korea University Hospital. The evaluation of the clinical sensitivity was performed with 129 specimens and the evaluation of clinical specificity was conducted with an additional 99 specimens. Results were achieved by comparing the results obtained with the LyteStar™ TB/NTM Kit against results obtained by mycobacteria culture for the individual specimen. Specimens with discrepant results between culture and the LyteStar™ TB/NTM Kit were resolved by review of the patient’s clinical records. Results are summarized below.