This CE-marked test kit features multiplex fluorescence detection technology, enabling absolute quantification of common bloodstream infection or sepsis pathogens and key drug resistance genes in a single assay with high sensitivity and specificity. When combined with a fully automated digital PCR platform, the entire sample-to-report workflow is completed in just 3 hours-delivering critical insights to guide early 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 in 3 hours – Rapid time-to-result for timely intervention.

02/

Initial BSI screening–Early identification of bloodstream infections.

03/

Early sepsis detection–Prompt alerts for critical cases.

04/

Diagnostic support–Aids in clinical decision-making.

05/

Dynamic monitoring–Track infection progression or treatment response.

06/

No blood culture needed–Direct testing without culture delays.

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:

Results typically take 2–3 days or longer.

Low Positive Rate

Positive cultures are detected in only approximately 10% of cases.

Risk of False Results

Susceptible to both false-negative and false-positive findings.

Contamination Prone

Sample contamination during processing is a significant concern.

Large Blood Volume

Requires 20–60 mL of blood per draw.

Limited Monitoring Utility

Not well-suited for tracking disease progression or treatment response.

Core Advantages of the Digital PCR Detection Kit

1, Rapid and Efficient – Results in just 3 hours from sample to answer, meeting the urgent clinical need for speed.

2,High Positive Rate – Delivers a ≥200% improvement in detection positivity compared to blood culture.

3,Small Sample Volume – Requires only 2–5 mL of whole blood.

4,Dynamic Monitoring – Enables tracking of pathogens and resistance genes, supporting timely and precise antimicrobial adjustments.

5,Easy to Operate – Fully integrated with the AP10 and AD3207 systems for a highly automated workflow.

6,Clinically Validated – Backed by extensive clinical trials, with medical consensus supporting its use for early sepsis screening in suspected patients.

Why Hours Matter: 3 Hours vs. 3 Days

Time Point	Our Solution (3 Hours)	Traditional Blood Culture Workflow (2-3 Days)
Hour 1	Sample collected; detection initiated.	Sample placed in culture instrument; microbial growth phase begins.
Hour 3	Report issued - with pathogen ID, load quantification, and key resistance markers (e.g.,MRSA, ESBL) identified. Clinicians can initiate precise,targeted therapy immediately.	Blood culture may show early positivity (typically >12 hours),but cannot identify the pathogen or provide susceptibility data. Physicians continue empirical therapy without actionable guidance.
Hours 12–24	Patient has received targeted therapy for 12-24 hours; early clinical improvement may already be observable.	Blood culture positivity confirmed; additional steps-smear and subculture -are initiated, requiring another 12-24 hours.
Hours 48–72	Objective response assessment is possible by monitoring pathogen load changes, allowing timely therapy optimization.	Preliminary susceptibility results become available. Physicians begin adjusting antibiotics only now-2-3 days after sampling, during which the patient has remained on empirical therapy.