in vitro Diagnostics

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LyteStar™ Detection Kits

The LyteStarTM detection kits have been designed and developed to meet previously unmet customer needs in the Asia Pacific region. All kits have been validated with reference materials and patient samples and utilize specific primers and probes for target amplification and detection. All kits contain Internal Controls as well as Positive and Negative Controls for reliable data analysis.

LyteStarTM TB/NTM PCR Kit

For detection and differentiation of Mycobacterium tuberculosis complex and non-tuberculous mycobacteria (NTM) using real-time PCR

Clinical Performance

The LyteStarTM 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 LyteStarTM TB/NTM Kit against results obtained by mycobacteria culture for the individual specimen. Specimens with discrepant results between culture and the LyteStarTM TB/NTM Kit were resolved by review of the patient’s clinical records. Results are summarized below.

LyteStarTM Leptospira PCR Kit

The LyteStarTM Leptospira PCR Kit 1.0 is based on real-time PCR technology, for the qualitative detection of Leptospira-specific DNA. The kit was designed to detect all pathogenic Leptospira species. Detection of an Internal Control is included in the assay to monitor PCR inhibition and prevent false-negative results. The kit has been validated with EDTA whole blood, plasma and urine.

LyteStarTM HIV-2 RT-PCR Kit

The LyteStarTM HIV-2 RT-PCR Kit 1.0 is based on real-time PCR technology, for the detection and quantification of HIV-2 specific RNA. The kit is designed to target the 5’LTR region, utilizing reverse-transcription (RT) reaction to convert RNA into complementary DNA (cDNA), polymerase chain reaction (PCR) for the amplification of specific target sequences and target specific probes for the detection of the amplified DNA. Detection of an Internal Control is included in the assay to monitor PCR inhibition and prevent false-negative results. The kit has been validated with plasma.

LyteStarTM HCV Genotyping RT-PCR Kit

The LyteStarTM HCV Genotyping RT-PCR Kit 2.0 is a ready-to-use in vitro diagnostic test, based on real-time PCR, for the detection and identification of HCV Genotypes 1 – 6, and further typing of Subtypes 1a and 1b. Besides individual genotyping assays for above targets, the kit contains an amplification system for all HCV genotypes (HCV consensus) and, besides individual typing of HCV 1a and 1b, another assay for all HCV 1 genotypes. The kit includes an Internal Control (IC) to identify possible PCR inhibition, monitor the nucleic acid extraction procedure and to confirm the integrity of the reagents of the kit. The validated sample material for the kit is EDTA plasma.

Validation data – LOD per Genotype