Real-time PCR and flow cytometry kits for STI, Group B Streptococcus and sperm DNA testing

Inogen develops and manufactures advanced molecular diagnostic kits including the Inogen Vaginal Infections & STIs Fast Real-time PCR Kit, Inogen I-GBS Real-time PCR Kit for antenatal screening, and the Inogen Sperm DNA Fragmentation Kit (SCSA flow cytometry).

Inogen operates compliant with the ISO 13485:2016 Quality Management System for Medical Devices and manufactures products adhering to CE-IVD international regulatory standards.

Each kit has instructions for use and a brochure, available as PDFs on its product page and in Resources. The instructions state the kit's regulatory status, targets, specimens, instruments and storage.

The I-GBS PCR run takes about two hours after DNA extraction, and the sperm DNA fragmentation test takes about 7 to 10 minutes per sample on the flow cytometer. Run conditions and analytical sensitivity for each kit are in its instructions for use.

Brochures and instructions for use for every kit can be opened in the browser or downloaded as PDFs from each product page and from the Resources section.

Inogen Pty Ltd is based in Queensland, Australia. Postal address: PO Box 8380, Gold Coast MC QLD 9726, Australia. Phone +61 413 333 336 (Australia) or +84 90 438 6385 (Vietnam). Email: binh@inogen.world.

The Vaginal Infections & STIs Fast Real-time PCR Kit is validated on the Bio-Rad CFX96 Real-time PCR Detection System and the QuantStudio 5 and 7 Real-time PCR Systems. The I-GBS Real-time PCR Kit is validated on the QuantStudio 5 and 7 and the CFX96.

Vaginal swabs and urine for the STI kit, vaginal-rectal swabs for the I-GBS kit, and semen for the Sperm DNA Fragmentation Kit, as set out in each kit's instructions for use.

Twelve targets in three multiplex mixes in a single run: Neisseria gonorrhoeae, Chlamydia trachomatis, Trichomonas vaginalis, Mycoplasma genitalium, Gardnerella vaginalis, Ureaplasma urealyticum, Ureaplasma parvum, Mycoplasma hominis, Candida albicans, Treponema pallidum, and herpes simplex virus types 1 and 2.

The kit targets the cfb gene of Group B Streptococcus with a limit of detection of 100 CFU/mL. No cross-reactivity was found with the 12 other species tested, including S. aureus, E. faecalis, E. coli and C. albicans, and in silico analysis covers 11 GBS variants.

A flow cytometer with a 488 nm laser. At least 5,000 sperm are analysed per sample, and the kit reports the DNA Fragmentation Index (DFI) and High DNA Stainability (HDS).

Samples can be stored, because the sperm preservation reagent allows storage at 2 to 8 °C for up to 72 hours, at −20 °C for up to 7 days or at −80 °C for up to 30 days, so liquid nitrogen is not needed.

The STI kit is stored at −20 °C (±5 °C) and used within 8 weeks of opening. The I-GBS kit is stored at −20 °C (±5 °C) for up to 12 months with no more than 3 freeze-thaw cycles. The Sperm DNA Fragmentation Kit is stored at 2 to 8 °C.

Each kit's status is stated in its instructions for use: the I-GBS and Sperm DNA Fragmentation kits are labelled IVD, and the STI kit is labelled for research use only. Status may differ between countries, and research use only products are not for use in diagnostic procedures.

Send an enquiry through the contact form or email binh@inogen.world with the kit, quantity and delivery country. Inogen supplies laboratories directly from Vietnam and Australia.