Sepsis Overview

Clinical application- Bloodstream Infections: Huge Market, Existing Technologies Fail to Meet Clinical Needs

The number of morbidities is high:

• Global: 49 illion 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 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 misused to inhibit colony growth, and blood cultures are often not culturable

—Longer incubation, more sets of blood drawn, increased detection rate, empirical, susceptible to environmental influences

• Long testing time, 3-5 days, not able to give an effective diagnosis in time

• High sample volume requirements, 40-60 ml of blood drawn, poor clinical accessibility

Technology

Detection

Sensitivity

Specificity

Cost(USD)

Overall assessment

blood culture

3-5d

+

+

$20-$30

Gold standard, but outdated technology unable

to meet clinical needs

mNGS/tNGs

24-72h

+++

++

$400-$700

Heavily influenced by host gene background, poor sensitivity and specificity; poor timeliness; can not detect antibiotic resistant genes

qPCR(filmarray)

17.2h

++

+++

$100-$125

Blood culture requirde before testing Cannot be absolutely quantified

digital PCR

4-5h

+++

+++

$20-$30

absolute quantification High sensitivity + fast detection Direct whole blood detection, no blood culture required

Bloodstream Infection:

Digital PCR's core advantage, Fast and Accurate Meeting Clinical Needs

Bloodstream Infection:

Digital PCR's core advantage,

Fast and Accurate Meeting Clinical Needs

Blood Culture is clinical golden standard but with delayed turn around time

Often lead to unnecessarily long courses of empiric broad- spectrum antibiotics (i.e., antibiotics given without knowledge of the etiologic agent), exposing patients to unnecessary risk of adverse events, and leading to selection pressure for downstream resistance.

Analytical performance characteristics

RainSure digital PCR multiplexing bloodstream infection detection solution
• Results can be obtained directly from patient whole blood in less than 5 hours without the need for blood cultures
• The RainSure solution is the only dPCR platform available for direct testing of patient whole blood samples
• The solution has been validated on ICU patient samples from more than 10 hospitals with over 2,000 beds
• Panels cover 21 highly prevalent bacteria and fungi. Panel covers common clinical antibiotic resistance genes (ARGs) available

Gram Positive Bacteria

Enterococcus faecalis

Enterococcus faecium

Streptococcus pneumoniae

Straphylococcus epidermidis

Straphylococcus haemolyticu

Straphylococcus capitis

Straphylococcus aureus

Straphylococcus hominis

Gram Negative Bacteria

Acinetobacter baumannii

Bacteroides fragilis

Pseudomonas aeruginosa

Stenotrophomonas maltophilia

Enterobacter cloacae

Escherichia coli

Klebsiella pneumoniae

Proteus mirabilis

Salmonella enterica

Pneumocystis jirovecii

Fungi

Candida parapsilosis

Aspergillus fumigatus

Candiada albicans

Candida tropicalis

Candida glabrata

Cryptococcus neoformansi

Candida Krusei

Antimicrobial Resistance Genes

CTX-M

NDM

mcr-1

KPC

vanA/B

mecA/C and MREJ(MRSA)

mecA/C

OXA-48-like

VIM

All-in-one Digital PCR System RS32 SYSTEM

Contrasting RainSure's previous generation DropX individual digital PCR system, the RS32 series seamlessly unites the PCR Amplifying Apparatus and the Biochip Scanner into a harmonious whole, achieving true fully automatic integration following the introduction of nucleic acid samples.

DropX 2044 digital PCR system

Third generation digital PCR technology
Quickly achieve absolute quantification of single molecules

Digital PCR Cartridge

A digital PCR cartridge is a specialized device used to perform the dPCR assay. The cartridge serves as a platform for partitioning the PCR reaction mixture into numerous individual reaction chambers, where each chamber represents a separate PCR reaction. A single cartridge can process up to four samples.

Heat Transfer Film

Heat transfer film refers to a specialized film or thermal interface material used to ensure efficient and uniform heat transfer between the digital PCR cartridge and the heating/cooling elements of the PCR Amplifying Apparatus.

Sepsis Pathogenic Microorganism Detection Kit (Digital PCR)

An innovation in rapid sepsis molecular diagnosis. The digital PCR detection method can accurately determine the type and load of pathogenic microorganism in the blood without the need for blood culture steps and plays an extremely critical role in the treatment of infection.

Droplet Generation Oil

Droplet generation oil is a specialized oil-based fluid that is used to create and stabilize the droplets in dPCR. The oil is immiscible with the PCR reaction mixture, forming a distinct phase that surrounds and encapsulates the reaction mixture droplets. This oil barrier helps to isolate and compartmentalize each PCR reaction, preventing cross-contamination and ensuring accurate quantification of target nucleic acids.
Doctors are using RainSure dPCR sepsis tests helping ICU patients from department of infection in the first affiliated hospital of Soochow University weekly

Case Studies