BIOTIA-ID, the next generation of urinary tract infection diagnostics

• The BIOTIA-ID Urine NGS Assay is a qualitative next-generation sequencing (NGS)-based in-vitro diagnostic test powered by BIOTIA-DX software.  The assay detects nucleic acid of a panel of common, clinically-relevant uropathogens in unpreserved urine. The identification of specific pathogen DNA in samples from patients with signs and symptoms of urinary tract infection caused by bacteria helps to diagnose these infections in conjunction with other clinical or laboratory findings. Detection of the reported microbial organisms should be interpreted within the context of clinical information, medical history, epidemiological findings, and other laboratory results.
• BIOTIA-ID Urine NGS Assay detects Gram-Negative Enterobacteriales (Citrobacter species, Enterobacter aerogenes, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Klebsiella variicola, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Raoultella ornithinolytica, Serratia marcescens), Gram-Negative Non-Enterobacteriales (Acinetobacter baumanii, Acinetobacter lwoffii, Pseudomonas aeruginosa, Stenotrophomonas maltophilia), Gram-Positive Bacteria (Aerococcus species, Anginosus-Group Streptococci, Corynebacterium urealyticum, Enterococcus faecalis, Enterococcus faecium, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Staphylococcus saprophyticus, Other Staphylococcus species, Streptococcus agalactiae, Mitis-Group Streptococci), Anaerobic Bacteria (Anaerococcus vaginalis, Bacteroides fragilis, Prevotella species), Other Bacteria (Gardnerella vaginalis), and ​Fungal Species ​(Candida albicans, Candida auris, Candida dubliniensis, Candida glabrata, Candida kefyr, Candida krusei, Candida lusitaniae, Candida parapsilosis, Candida tropicalis, Candida guilliermondii ).

• Proper collection, preparation and handling of specimen is required to ensure accurate test results.
• Samples should be collected as clean catch mid-stream urine specimen collected in a sterile urine cup or urine culture transport tube (UTT) or invasively collected specimens such as those collected by suprapubic catheter or from the renal pelvis.
• Specimens in sterile cups are stable for up to 24 hours at room temperature or up to 72 hours when stored at 2°C to 8°C, Specimens in UTT are stable for up to 48 hours at room temperature or for up to 1 week when stored at 2°C to 8°C.

• Place specimen in a biohazard bag before transporting.
• Place the bag in a FedEx UN3373 Category B Pack if mailing specimen.
• Transportation of patient samples must comply with all applicable governing regulations for the transport of etiologic agents.

The BIOTIA-ID Urine NGS Assay is currently under review by NYS as an in vitro diagnostic laboratory developed test (LDT). This assay was developed and its performance characteristics determined by Biotia. The assay has not been cleared or approved by the FDA, nor is it required to be. The Biotia Laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88) and is accredited to perform high-complexity clinical laboratory testing.