HCY™ Leptospira (Lep) Real-time PCR Detection Kit (Lyophilized Bead)

HCY™ Leptospira PCR Detection Kit

• Designed based on the gene sequences of pathogens prevalent in various regions of the world, fully guaranteeing the accuracy and validity of the test;
• The primers are designed with special bases to reduce the risk of missed detection due to gene mutation;
• Adopting pre-filled freeze-dried microsphere technology for transportation and storage at room temperature;
• Easy to use, no need to prepare reagents in advance;
• The minimum detection limit is 10 copies/Test;
• Clinical sensitivity 100%, specificity 100%;
• Add internal standard to prevent false negative results and facilitate indoor quality control.

Quality by Design

A total of 113 sequences of leptospiral sequences SecY (CP092739.1), lipl32 (CP040840.1), and secY (CP092660.1) included on NCBI GenBank were compared for homology comparison, and an evolutionary tree was constructed for analysis.

HCY™ Leptospira PCR Detection Kit is designed and developed based on the gene sequences of endemic pathogens in different regions of the world, as mentioned above, which fully ensures the accuracy and validity of the detection. At the same time, special bases are introduced in the primer sequence synthesis process to reduce the risk of missed detection due to gene mutation.

LoD and PCR Efficiency

Using real clinical samples, the assay was performed after serial gradient dilution, and the results showed good linear characteristics, and the calculated copy number was as low as 10 copies/Test. Calculation of the experimental data set yielded R2=0.9939 and the amplification efficiency E=105.39%.

Sensitivity and Specificity

The HCY™ Leptospira PCR Detection Kit was compared to similar commercially available products and tested 262 real clinical samples, of which the sensitivity was 100% and the specificity 99.59%.

Cross-reactivity

The HCY™ Leptospira PCR Detection Kit has been validated for the detection of Feline herpesvirus, Bartonella, Borrelia Burgdorferi, Leptospira, Bordetella bronchiseptica, Feline Calicivirus, Feline coronavirus, Feline Parvovirus, Chlamydia felis, Mycoplasma haemofelis, Candidatus Mycoplasma haemominutum and Candidatus Mycoplasma haemominutum. Candidatus Mycoplasma turicensis, Canine parainfluenza Virus, Canine Coronavirus, Canine Herpesvirus, Canine Distempervirus, and Canine Parvovirus. None of them cross-reacted.