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Sepsis Pathogenic Microorganism Detection Kit (Digital PCR)

Product Highlights

  • Results can be obtained directly from patient whole blood in less than 5 hours without the need for blood cultures
  • Highly automated; prevents laboratory-acquired infection
  • The solution has been validated on ICU patient samples from more than 10 hospitals with over 2,000 beds
  • Panels cover up to 31 highly prevalent bacteria and fungi and 9 common clinical antibiotic resistance genes (ARGs).

Product Description

A high-multiplex digital PCR assay designed for direct whole-blood detection of critical sepsis pathogens, offering superior sensitivity, rapid turnaround, and actionable results.

Why sepsis?

Bloodstream infection refers to a systemic infectious disease caused by bacteria, viruses, fungi, etc., invading the bloodstream, which can lead to sepsis. Sepsis refers to life-threatening organ dysfunction resulting from a dysregulated host response to infection. It has the characteristics of high morbidity, a high disability rate, and a high mortality rate, and is one of the causes of in-hospital death in patients in the intensive care unit.

The number of morbidities is high:

  • Global: 49 million people/year (WHO, 2020)
  • China: about 6.11 million people/year

High mortality rate:

  • Global deaths: 11 million/year (WHO, 2020)
  • Morbidity and mortality rate of more than 30%, plus cognitive dysfunction rate of 16.7%

Rapid onset:

  • 58% increase in risk of death for each 6-hour delay in treatment
  • Delaying treatment by two days increases the risk of death by 38.8 times

The gold standard – blood cultures:

  • Low sensitivity:

- Broad-spectrum antibiotics are often misused, inhibiting colony growth

- Many pathogens cannot be cultured

  • Longer incubation:

- More sets of blood are required

- Detection is empirical and susceptible to environmental influences

  • Long testing time:

- 3–5 days — often too slow for effective diagnosis

  • High sample volume requirement:

- 40–60 mL of blood needed → poor clinical accessibility

Comparison of Standard Diagnostic Methods vs. Digital PCR

Technology
Detection
Sensitivity
Specificity
Cost
Overall assesment
blood culture
3-5d
+
+
+
Gold standard for pathogen identification, but slow and technologically outdated, often failing to meet urgent clinical needs
mNGS / TNGs
24–72h
+++
++
++++
High cost and long turnaround time; performance affected by host background, resulting in variable sensitivity and specificity; limited ability to detect antimicrobial resistance
qPCR (FilmArray)
17.2h
++
+++
++
Useful for targeted detection with good specificity, but requires prior blood culture and cannot provide absolute quantification
digital PCR
4-5h
+++
+++
++
Fast, highly sensitive, and highly specific with absolute quantification; RainSure's solution enables direct whole-blood detection with no culture step required

Product Specifications

Multiplex Detection Panels:

  • Panel 1 & 2: 21 key pathogens: 8 Gram-negative, 7 Grav-positive, 6 fungi (CE-IVD Certified)
  • Panel 3: 10 additional pathogens (Research Use Only)
  • Panel 4: 9 antibiotic resistance genes (Research Use Only)
Position 1
Position 2
Position 3
Position 4
Position 5
Panel 1
FAM&HEX
Staphylococcus capitis
Acinetobacter baumannii
Candida tropicalis
Candida krusei
Staphylococcus epidermidis
ROX&Cy5
Enterococcus faecium
Cryptococcus neoformans
Stenotrophomonas maltophilia
Klebsiella pneumoniae
Streptococcus pneumoniae
Cy5.5
Serratia marcescens
Panel 2
FAM&HEX
Bacteroides fragilis
Escherichia coli
Candida parapsilosis
Pseudomonas aeruginosa
Pseudomonas aeruginosa
ROX&Cy5
Enterococcus faecalis
Haemophilus influenzae
Pseudomonas aeruginosa
Pseudomonas aeruginosa
Pseudomonas aeruginosa
Cy5.5
Internal Control
Panel 3
FAM & HEX
Burkholderia cepacia
Citrobacter freundii
Streptococcus pyogenes
Morganella morganii
Staphylococcus haemolyticus
ROX & Cy5
Klebsiella aerogenes
Klebsiella oxytoca
Corynebacterium striatum
Proteus mirabilis
Moraxella catarrhalis
Panel 4
FAM & HEX
OXA23
VanA
VanB
ROX & Cy5
OXA48
MecA
MecC
blaKPC
blaNDM
Cy5.5
SmeDEF