Sepsis-Q Real-Time PCR Kit

Product Overview

Sepsis is a condition primarily caused by the inflammatory response of the immune system to bacterial, viral, protozoan, or fungal infections in the lungs, brain, urinary tract, skin, or abdominal area. In the absence of early diagnosis and timely treatment, sepsis may advance to severe septic shock, leading to organ failure and death. Sepsis afflicts more than 30 million people globally and is a leading cause of maternal and newborn illnesses and fatalities, particularly in low- and middle-income nations.

To address this critical clinical need, Genes2Me introduces the Sepsis-Q Real-Time PCR Kit, a multiplex molecular diagnostic solution designed for the qualitative detection of Sepsis related pathogen DNA extracted from human whole blood or positive blood culture samples. The assay is intended to be performed by a laboratory professional in a clinical laboratory.

Targets:
32 Major Sepsis causing Pathogens
Technology:
Real-Time PCR (Multiplex qRT-PCR)
Detection:
Qualitative (Detected / Not Detected)
Sample Type:
Whole Blood, Positive Blood Culture
Certification:
IVD
Sepsis-Q Comprehensive

How the Assay Works

The Sepsis-Q Kit is a multiplex real-time PCR assay designed for the specific amplification of Sepsis specific DNA target sequences. The assay employs primers and probes labelled with four distinguishable fluorescent dyes (FAM, HEX, Texas Red, and Cy5), allowing parallel detection of 32 major sepsis causing organisms and an Internal Control through corresponding detector channels on an open real time PCR instrument. The kit consists of qRT-PCR Master Mix and 8 tubes comprising primer probe mixes for different pathogens, covering Staphylococcus aureus, Acinetobacter baumannii, Aspergillus fumigatus, Escherichia coli, Pseudomonas aeruginosa, Klebsiella pneumoniae, CoNS spp. (Staphylococcus epidermidis and Staphylococcus haemolyticus), Enterococcus faecium, Listeria monocytogenes, Enterobacter cloacae, Streptococcus spp. (S. pyogenes and S. agalactiae), Enterococcus faecalis, Streptococcus pneumoniae, Stenotrophomonas maltophilia, Candida albicans, Candida nonalbicans species (C. parapsilosis, C. tropicalis, and C. krusei), Enterococcus gallinarum, Serratia marcescens, Candida nonalbicans species (C. auris and C. glabrata), Campylobacter spp., Salmonella enterica, Haemophilus influenzae type B, Proteus mirabilis, Enterobacter aerogenes, Fusarium spp., Bacteroides fragilis, and Klebsiella oxytoca, with an Internal Control integrated into Tube 6, 7, and 8 to validate DNA extraction, PCR inhibition, and overall assay performance.

Clinical Relevance

Escherichia coli, Klebsiella pneumoniae, Staphylococcus aureus, Staphylococcus epidermidis, Enterococcus faecalis, Enterococcus faecium, Pseudomonas aeruginosa, Candida albicans, Candida glabrata, and Candida tropicalis are among the most common organisms which cause sepsis. In early and later ages, compromised immune systems brought on by cancer, diabetes, severe trauma, or burns are risk factors for sepsis. Rapid identification of the causative pathogen directly supports timely, targeted treatment decisions and helps reduce the risk of progression to severe septic shock, organ failure, and death.

Sample Type & Reporting Output

Sample Type:
Human Whole Blood, Positive Blood Culture
Reporting Output:
Qualitative detection of Sepsis related pathogen DNA (Detected / Not Detected)
Targets Detected:
32 major sepsis causing organisms

Key Features & Benefits

Comprehensive Multiplex Detection

Parallel detection of 32 major sepsis causing organisms across 8 primer probe tubes using four distinguishable fluorescent dyes (FAM, HEX, Texas Red, and Cy5).

Integrated Internal Control

An Internal Control integrated into Tube 6, 7, and 8 validates DNA extraction, PCR inhibition, and overall application performance in every run.

High Analytical Performance

100% analytical sensitivity and 100% analytical specificity, with a limit of detection of 100 copies per ml and a measuring range of 1 to 109 copies per reaction.

Strong Clinical Performance

98% clinical sensitivity and 99% clinical specificity support dependable qualitative result interpretation.

Long Shelf Life

The kit has a shelf life of 12 months from the date of manufacture and remains stable until the labelled expiration date when stored as specified.

Flexible Compatibility

Validated on leading Real-Time PCR platforms including Thermo Fisher QuantStudio 5, Bio-Rad CFX96, Roche LightCycler 480, and Genes2Me RapiCycler 96.

Versatile Sample Compatibility

Designed for human whole blood and positive blood culture samples, supporting routine clinical workflows for sepsis diagnosis.

Applications

  • Rapid identification of causative bacterial and fungal pathogens in patients with suspected sepsis or bloodstream infection
  • Supporting clinical decision making in intensive care and emergency settings where timely pathogen identification influences patient outcomes
  • Guiding targeted antimicrobial therapy and supporting antimicrobial stewardship programs in hospital and critical care laboratories
  • Testing of positive blood culture samples to confirm and speciate the causative organism following initial culture positivity
  • Surveillance and epidemiological monitoring of sepsis causing organisms within clinical microbiology laboratories

Analytical Performance

  • Analytical sensitivity of 100% and analytical specificity of 100% for detection of Sepsis related pathogen DNA
  • Trueness (bias) of 99% and accuracy (resulting from trueness and precision) of 99%
  • Precision with a coefficient of variation of less than 2% for both repeatability and reproducibility
  • Limit of detection of 100 copies per ml, with a measuring range of 1 to 109 copies per reaction and linearity of R squared equals 0.999
  • Ct value cut off of less than or equal to 35 for differentiating positive and negative results
  • Well controlled identification and control of known relevant endogenous and exogenous interfering substances, including human genomic DNA, NaCl, BSA, and hemoglobin
  • No cross reactivity observed against Chlamydia pneumoniae, Mycoplasma pneumoniae, Bordetella pertussis, and Legionella pneumophila
  • Compatible with QuantStudio 5, CFX96, LightCycler 480, and RapiCycler 96 platforms
  • Clinical sensitivity of 98% and clinical specificity of 99%
  • Manufactured under strict quality standards with reagent stability maintained under recommended storage conditions of negative 30 degrees Celsius to negative 10 degrees Celsius

With the Sepsis-Q Real-Time PCR Kit, laboratories can achieve sensitive, specific, and clinically meaningful detection of the major pathogens responsible for sepsis. By supporting rapid pathogen identification across a broad multiplex panel, the kit helps clinicians make timely, informed decisions for patient care and disease management. Empower your laboratory with the Sepsis-Q Real-Time PCR Kit, because rapid molecular insights can make a lasting difference in patient outcomes.

Data Analysis and Report

Sepsis-Q Real Time PCR Kit

Sepsis-Q Real Time PCR Kit, specific amplification plot of Treponema pallidum Positive Control (HEX Channel) along with Internal Control (Cy5 Channel)

Ordering Information

Commercial Name Old Cat No. New Cat No. Pack Size
Sepsis-Q Real Time PCR Kit G2M804026 G610027 25 Tests

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Since its inception in 2016, Genes2me has been constantly striving towards setting a benchmark in the diagnostics space by introducing premium quality (Made in India) diagnostic kits which are CE-IVD, ISO-13485:2016, and ISO 9001:2015 certified, assuring our clients of unparalleled quality and compliance with international standards.

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