Laboratory-Developed Tests (LDT)

RESPIRATORY PATHOGENS PANEL (RPP) MAXI KIT

The Respiratory Pathogens Panel (RPP) Maxi Kit is a multiplex real-time PCR assay designed for the qualitative detection and differentiation of multiple respiratory pathogens in clinical specimens, including viruses such as Covid19, Influenza A/B, Respiratory Syncytial Virus A/B, Rhinovirus V, Boca Virus, Human Metapneumovirus, and bacterial pathogens like Streptococcus A, Moraxella, Klebsiella pneumoniae, and Bordetella pertussis. This assay assists in diagnosing respiratory infections in symptomatic individuals, supporting healthcare professionals in clinical decision-making. It is intended for use in clinical laboratories by trained personnel andshould not be the sole basis for diagnosis, as it does not differentiate between live and dead pathogens.

SEXUALLY TRANSMITTED INFECTIONS PANEL MIDI KIT

SEXUALLY TRANSMITTED INFECTIONS PANEL MIDI KIT (Ref Number: VSNTI001) is intended for the qualitative detection and differentiation of sexually transmitted pathogens, including HSV-I, HSV-II, Ureaplasma urealyticum, Treponema pallidum, Gardnerella vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, and others. This multiplex RT-PCR-based kit is compatible with multiple fluorescence channels (FAM, HEX, ROX, CY5), enabling the simultaneous detection of multiple targets in a single test. Designed for use in clinical
laboratories, it provides accurate and reliable results, assisting healthcare professionals in diagnosing sexually transmitted infections and supporting effective patient management.

URINARY TRACT INFECTIONS PANEL MIDI KIT

The Urinary Tract Infections Panel MIDI Kit is intended for the qualitative detection and differentiation of urinary tract infection (UTI) pathogens from human biological specimens, such as urine samples. Utilizing multiplex RTPCR technology across four tubes, this kit targets a broad range of bacterial and fungal pathogens, including E.coli, Streptococcus agalactiae, Klebsiella spp., Staphylococcus saprophyticus, Enterobacter cloacae, Pseudomonas aeruginosa, Candida albicans, and others. Compatible with fluorescence channels (FAM, HEX, ROX, CY5), the kit enables simultaneous detection of multiple UTI-causing organisms. Designed for use in clinical
laboratories, it assists healthcare professionals in diagnosing UTIs and supporting effective patient management.

ANTIBIOTIC RESISTANCE GENE PANEL MIDI KIT

The Antibiotic Resistance Gene Panel MIDI Kit is intended for the qualitative detection and differentiation of antibiotic resistance genes in human clinical specimens. Utilizing multiplex RT-PCR technology across four tubes, this kit identifies a broad range of resistance markers, including KPC, VIM, IMP, OXA, QNR a-b-s, VANA/VANB, MEC A/MEC C, NDM, SUL, CTX, and DFRA. Compatible with fluorescence channels (FAM, HEX, ROX), the kit allows for the simultaneous detection of multiple targets in a single run. Designed for clinical laboratories, this kit supports the identification of resistance genes to assist in infection control and optimize
antimicrobial treatment strategies.

WOMAN HEALTH/VAGINITIS INFECTIONS PANEL MIDI KIT

The Woman Health/Vaginitis Infections Panel MIDI Kit is intended for the qualitative detection and differentiation
of pathogens associated with vaginitis and other women’s health infections. Using multiplex RT-PCR technology across four tubes, this kit detects a wide range of microorganisms, including Haemophilus ducreyi, BVAB-2, Candida spp., E. coli, Streptococcus agalactiae, Lactobacillus spp., and others. Compatible with fluorescence channels (FAM, HEX, ROX, CY5), it allows the simultaneous identification of multiple pathogens in one run. Designed for clinical laboratories, this kit supports accurate diagnosis and effective patient management.

MEN HEALTH INFECTIONS PANEL MAXI KIT

The Men Health Infections Panel MAXI Kit is designed for the qualitative detection and differentiation of pathogens associated with male reproductive and urogenital infections from human clinical specimens. Utilizing advanced multiplex RT-PCR technology across eight tubes, this comprehensive kit identifies a wide range of bacterial, fungal, and viral pathogens, including Haemophilus ducreyi, BVAB-2, Chlamydia trachomatis, Candida spp., Treponema pallidum, Mycoplasma spp., Neisseria gonorrhoeae, and others. Compatible with fluorescence channels (FAM, HEX, ROX, CY5), it allows simultaneous detection of multiple pathogens in a single test. Intended for use in clinical laboratories, this kit supports the accurate diagnosis and management of male health infections.

GASTROENTERITIS PANEL MAXI KIT

The Gastroenteritis Panel MAXI Kit is designed for the qualitative detection and differentiation of pathogens associated with gastroenteritis from human clinical specimens. Utilizing advanced multiplex RT-PCR technology
across eight tubes, the kit targets a wide range of bacterial, viral, and parasitic pathogens, including Giardia lamblia, Cryptococcus spp., EPEC, ETEC, STEC, Vibrio cholerae, Adenovirus (F40/41), Rotavirus, Norovirus (GI/ GII), and others. Compatible with fluorescence channels (FAM, HEX, ROX, CY5), it allows simultaneous identification of multiple pathogens in a single test, supporting rapid and comprehensive diagnostics. Intended for use in clinical laboratories, this kit aids in the effective diagnosis and management of gastroenteritis.

CULTURE AND SENSITIVITY TICK-BORNE PANEL MAXI KIT

The Culture and Sensitivity Tick-Borne Panel MAXI Kit is designed for the qualitative detection and differentiation of pathogens associated with tick-borne diseases from human clinical specimens. Utilizing advanced multiplex RT-PCR technology across eight tubes, this comprehensive kit targets a wide range of bacterial, viral, and parasitic pathogens, including Ehrlichia chaffeensis, Borrelia burgdorferi, Anaplasma phagocytophilum, Francisella tularensis, Powassan virus, Theileria/Babesia spp., and others. Compatible with fluorescence channels (FAM, HEX, ROX, CY5), it enables simultaneous detection of multiple tick-borne pathogens in a single test. This kit is intended for use in clinical laboratories to support accurate diagnosis and effective management of tick-borne diseases.

NAIL INFECTIONS PANEL MAXI KIT

The Nail Infections Panel MAXI Kit is designed for the qualitative detection and differentiation of pathogens associated with nail infections from human clinical specimens. Utilizing advanced multiplex RT-PCR technology across eight tubes, this comprehensive kit identifies a wide range of fungal and bacterial pathogens, including Trichophyton violaceum, Candida spp., Fusarium spp., Aspergillus spp., Microsporum spp., and others. Compatible with fluorescence channels (FAM, HEX, ROX, CY5), it allows simultaneous detection of multiple pathogens in a single run. Intended for use in clinical laboratories, this kit supports accurate diagnosis and effective management of nail infections.

HPV FULL GENOTYPING KIT

The HPV Full Genotyping Kit is designed for the qualitative detection and comprehensive genotyping of Human Papillomavirus (HPV) genotypes from human clinical specimens. Utilizing multiplex RT-PCR technology across eight tubes, this kit identifies a wide range of HPV genotypes, including high-risk and low-risk types such as HPV16, HPV18, HPV31, HPV45, HPV52, HPV58, HPV6/11, and others, along with an internal control (RP). Compatible with fluorescence channels (FAM, HEX, ROX, CY5), it enables precise and simultaneous detection of multiple HPV genotypes in a single test. This kit is intended for use in clinical laboratories to aid in the accurate diagnosis and monitoring of HPV-related conditions.

RESPIRATORY TYPE QPCR TEST KITS

The SARS-CoV-2 Detection Kit (Catalog Number: VSRNDB001), SARS-CoV-2/Flu/RSV Detection Kit (Catalog
Number: VSRNDB002), and the Mini Respiratory Pathogens Panel Type Test Kit (Catalog Number: VSNMR001) are intended for the qualitative detection and differentiation of respiratory pathogens, including SARS-CoV-2, Influenza A/B, RSV, and others. These kits use multiplex RT-PCR technology and are compatible with various fluorescence channels, enabling detection of multiple targets in one run. Designed for use in clinical laboratories, these kits assist in identifying respiratory pathogens to support diagnosis and patient management.

SEXUALLY TRANSMITTED INFECTIONS PANEL MAXI KIT

SEXUALLY TRANSMITTED INFECTIONS PANEL MAXI KIT (Ref Number: VSNTI002) is designed for the qualitative detection and differentiation of a wide range of sexually transmitted pathogens, including Haemophilus ducreyi, Neisseria gonorrhoeae, HSV-1, HSV-2, Ureaplasma spp., Mycoplasma spp., and others. Utilizing multiplex RTPCR technology across eight tubes and compatible with multiple fluorescence channels (FAM, HEX, ROX, CY5), this kit enables the simultaneous identification of bacteria, viruses, and fungi. Intended for use in clinical laboratories, it provides reliable results to support the diagnosis and management of sexually transmitted
infections.

URINARY TRACT INFECTIONS PANEL MAXI KIT

The Urinary Tract Infections Panel MAXI Kit is designed for the qualitative detection and differentiation of a comprehensive range of urinary tract infection (UTI) pathogens in human urine samples. Utilizing advanced multiplex RT-PCR technology across eight tubes, this kit identifies bacterial and fungal pathogens such as E. coli, Klebsiella spp., Proteus mirabilis, Enterobacter cloacae, Candida spp., Pseudomonas aeruginosa, Staphylococcus aureus, Ureaplasma spp., and others. Compatible with fluorescence channels (FAM, HEX, ROX, CY5), it allows simultaneous detection of multiple UTI-causing organisms in a single test. Intended for clinical
laboratories, it supports accurate UTI diagnosis and effective patient management.

ANTIBIOTIC RESISTANCE GENE PANEL MAXI KIT

ANTIBIOTIC RESISTANCE GENE PANEL MAXI KIT (Ref Number: VSNAR002) The Antibiotic Resistance Gene Panel MAXI Kit is designed for the qualitative detection and differentiation of a comprehensive range of antibiotic resistance genes in human clinical specimens. Utilizing advanced multiplex RT-PCR technology across eight tubes, this kit targets resistance markers such as KPC, VIM, NDM, IMP, OXA, MEC A/MEC C, VANA/VANB, SUL, CTX, DFRA, ErmB, TetM, AmpC, SHV, QnrA, AAC(6')-Ib-cr, and others. Compatible with fluorescence channels (FAM, HEX, ROX), it enables the simultaneous identification of multiple resistance genes in a single run. This kit is intended for use in clinical laboratories to support infection control, guide antimicrobial therapy decisions, and combat antimicrobial resistance.

WOMAN HEALTH/VAGINITIS INFECTIONS PANEL MAXI KIT

The Woman Health/Vaginitis Infections Panel MAXI Kit is designed for the qualitative detection and differentiation
of a broad range of pathogens associated with vaginitis and women’s health infections. Utilizing advanced multiplex RT-PCR technology across eight tubes, this comprehensive kit detects microorganisms such as Haemophilus ducreyi, BVAB-2, Candida spp., Lactobacillus spp., Mycoplasma spp., Treponema pallidum, E. coli, and others. Compatible with fluorescence channels (FAM, HEX, ROX, CY5), it enables the simultaneous identification of multiple bacterial, fungal, and viral pathogens in a single test. Intended for use in clinical
laboratories, this kit supports the accurate diagnosis and effective management of women’s health infections.

WOUND/SEPSIS PANEL MAXI KIT

The Wound/Sepsis Panel MAXI Kit is intended for the qualitative detection and differentiation of pathogens associated with wound infections and sepsis from human clinical specimens. Utilizing advanced multiplex RTPCR technology across eight tubes, this kit identifies a broad range of bacterial, fungal, and viral pathogens, including E. coli, Klebsiella spp., Staphylococcus aureus, Candida spp., HSV-1, HSV-2, VZV, Streptococcus agalactiae, Acinetobacter baumannii, and others. Compatible with fluorescence channels (FAM, HEX, ROX, CY5), the kit provides simultaneous detection of multiple pathogens, enabling comprehensive and rapid diagnostics. Designed for use in clinical laboratories, it supports the accurate diagnosis and effective management of wound infections and sepsis.

EAR/NOSE/THROAT PANEL MAXI KIT

The Ear/Nose/Throat Panel MAXI Kit is intended for the qualitative detection and differentiation of pathogens associated with ear, nose, and throat (ENT) infections from human clinical specimens. Utilizing multiplex RT-PCR technology across eight tubes, this kit identifies a comprehensive range of bacterial, fungal, and viral pathogens,
including Haemophilus influenzae, Klebsiella pneumoniae, Candida spp., Streptococcus pneumoniae, Trichomonas vaginalis, Staphylococcus aureus, HSV-1/2, EBV, and others. Compatible with fluorescence channels (FAM, HEX, ROX, CY5), it enables simultaneous detection of multiple pathogens in a single test. Designed for use in clinical laboratories, this kit supports the accurate diagnosis and management of ENT infections.

FUNGAL&NAIL INFECTIONS PANEL MAXI KIT

The Fungal & Nail Infections Panel MAXI Kit is intended for the qualitative detection and differentiation of fungal and bacterial pathogens associated with nail and fungal infections from human clinical specimens. Utilizing multiplex RT-PCR technology across eight tubes, this comprehensive kit identifies a wide range of pathogens, including Trichophyton spp., Microsporum spp., Malassezia spp., Aspergillus spp., Candida spp., and others. Compatible with fluorescence channels (FAM, HEX, ROX, CY5), it enables simultaneous detection of multiple pathogens in a single test. Designed for use in clinical laboratories, this kit supports accurate diagnosis and effective management of fungal and nail infections.

HPV DETECTION KIT

The HPV Detection Kit is designed for the qualitative detection and differentiation of high-risk Human Papillomavirus (HPV) genotypes from human clinical specimens. Utilizing multiplex RT-PCR technology, this kit targets multiple HPV genotypes, including HPV16, HPV18, HPV31, HPV33, HPV35, HPV39, HPV45, HPV51, HPV52, HPV54, HPV56, HPV59, HPV66, and HPV68, along with the internal control Rnase P. Compatible with fluorescence channels (FAM, HEX, ROX, CY5), it enables efficient and reliable detection of multiple HPV genotypes in a single test. Intended for use in clinical laboratories, this kit supports early diagnosis and monitoring of HPV-associated conditions.