This CE qualified test kit , utilizing multiplex fluorescence detection technology, enables the absolute quantification of common bloodstream infection pathogens and their key drug resistance genes in a single assay, with a higher detection sensitivity and accuracy. Combined with a fully automated digital PCR platform, the entire workflow from sample to report can be completed within 3 hours, significantly reducing the traditional days-long wait associated with blood culture and providing critical decision-making support for early clinical anti-infective therapy.

Detection Scope

(I) Detection Targets (Divided into 4 Panels)

Panel	Targets
One	Pseudomonas aeruginosa Klebsiella pneumoniae Escherichia coli Acinetobacter baumannii
Two	Staphylococcus aureus Enterococcus* Candida* Streptococcus*
Three	Stenotrophomonas maltophilia Enterobacter cloacae Proteus mirabilis Coagulase-negative staphylococci* Serratia marcescens
Four	KPC mecA OXA-48 NDM/IMP vanA/vanB

Remarks:

Enterococcus:Enterococcus faecalis, Enterococcus faecium
Candida:Candida albicans, Candida glabrata, Candida parapsilosis, Candida tropicalis,Candida krusei
Streptococcus:Streptococcus pneumoniae, Streptococcus anginosus, Streptococcus pyogenes, Streptococcus mitis and Streptococcus agalactiae
Coagulase-negative staphylococci:Staphylococcus epidermidis, Staphylococcus hominis, Staphylococcus cephalae, Staphylococcus haemolyticus, Staphylococcus lugdunensis, Staphylococcus warneri

(II) Applicable Sample Types

2-5 mL Peripheral Blood

Clinical Application Scenarios

01/

Results within 3 hours

02/

Initial screening for BSI

03/

Early warning for sepsis

04/

Auxiliary diagnosis

05/

Dynamic monitoring

06/

No blood culture required.

Core Background of Sepsis

1.Definition: Infection+SOFA≥2 , a life-threatening organ dysfunction caused by a dysregulated host response to infection, which is a systemic infectious disease triggered by pathogens such as bacteria and fungi invading the bloodstream.
2.Core Challenges:

High incidence: The incidence rate in developed countries is 437 per 100,000 people, 49 million in 2017 WHO data.
High mortality: The mortality rate ranges from 20% to 50%, resulting in about 11 million deaths annually(WHO, 2017).
High urgency for treatment: For every hour of treatment delay, the mortality rate increases by 7.6%; a 6-hour delay leads to a 58% rise in mortality.
High medical costs: The average hospitalization cost is as high as $11,390, with an average of $502 per day.

Limitations of Traditional Blood Culture Detection

Long turnaround time:

Taking 2-3 days or more.

Low positive rate:

About 10%.

False Result:

High possibilities of false results.

High contamination risk:

There is a high risk of contamination during the operation.

Large blood collection volume:

20ml-60ml blood samples in common.

Inconvenient Monitoring:

It can't be used for dynamic monitoring.

Core Advantages of the Digital PCR Detection Kit

1.Rapid and efficient: It only takes 3 hours from sample to result, meeting the clinical demand for rapid detection.
2.High positive rate: The positive rate is increased at least 200%.
3.Small sample volume required: Only 2 mL-5 mL of whole blood is needed.
4.Support for dynamic monitoring: It can dynamically monitor pathogens and antibiotic resistance genes in patients, guiding the timely and accurate adjustment of antimicrobial prescriptions.
5.Easy to operate: Equipped with the Automated Nucleic Acid Detection Reaction Construction System (AP10) and the Automated Digital PCR System (AD3207), it has a high degree of process automation.
6.Validation: It has undergone extensive clinical trials and the medical community has reached a consensus that our method can be used for early screening of suspected sepsis.

1. 3 Hours vs. 3 Days: The Fundamental Difference in Clinical Outcomes

Time Dimension	Our Solution (3 Hours)	Traditional Pathway (Blood Culture + qPCR, 2–3 Days)
Hour 1	Sample collection completed; detection process initiated.	Sample collected and placed in blood culture instrument. Enters the microbial growth waiting period.
Hour 3	Report issued: Pathogen identification, load quantification, and key resistance genes (e.g., MRSA, ESBL) determined. Clinicians can immediately adjust treatment with precision.	Blood culture instrument may signal early positivity (typically >12 hours), but cannot specify pathogen or provide susceptibility data. Physicians remain in the empirical treatment blind zone.
Hours 12–24	Patient has received over 24 hours of precise, targeted therapy; infection markers may already show improvement.	Blood culture preliminarily positive; confirmation steps (smear, subculture) initiated (requires an additional 12–24 hours).
Hours 48–72	First efficacy monitoring possible; objective assessment of therapeutic response via load changes allows timely optimization.	Preliminary susceptibility results available; physicians only begin adjusting antibiotics now. Patient has been under empirical therapy for 2–3 days.