What pathogens are detected by SepsiTest™?

>> More than 345 bacteria and fungi are potentially detectable by SepsiTest™ (sequence alignment algorithm). This makes SepsiTest™ the only molecular sepsis diagnostic test detecting all relevant blood-borne pathogens. See the growing list of pathogens identified during the current clinical studies here

Does SepsiTest™ detect pathogens directly from blood?

>> Yes. The test is designed for direct blood diagnostics using only 1 ml samples.

Does SepsiTest™ detect pathogens in sample types other than blood?

>> Yes. The test may be used to identify pathogens (research use only) from amniotic fluid, ascites fluid, blood and other body fluids from animal models, bronchoalveolar lavage (BAL), cerebrospinal fluid (CSF), heart valve material, pleural fluid, pus and abscess tissue, sample from positive blood cultures or colonies, smear from deep neck, smear from implant (e.g. prosthesis, stent, oxygenators), swabs, and synovial fluid. For an application overview, click here.

What about the sensitivity?

>> The sensitivity of SepsiTest™ is strain dependent. In several cases less than 40 cfu/ml (for instance, Candida spp., Staphylococcus spp.) or less than 100 cfu/ml blood (e.g. Enterococcus faecalis, Klebsiella pneumoniae) can be detected. For an updated list of strain-specific sensitivities, please contact This e-mail address is being protected from spam bots, you need JavaScript enabled to view it molzym.com

Does SepsiTest™ replace the blood culture? 

>> No. SepsiTest™ is currently used complementary to the blood culture because SepsiTest™ enables pathogen detection within 4 hours. Moreover SepsiTest™ focuses on blood culture-negative infections (e.g. blood culture-negative sepsis [BCNS], blood culture-negative endocarditis [BCNE]).

May SepsiTest™ be used for therapy monitoring?

>>Yes. Blood cultures may be strongly biased by antibiotics. SepsiTest™ detects pathogen DNA in dead and living cells in contrast to blood culture which depends on the ability of cells to divide.

Is SepsiTest™ biased by free DNA?

>>No. The unique SepsiTest™ DNA isolation technology specifically isolates DNA only from living or intact non-growing and dead cells while free DNA is degraded. This enables monitoring of the effect of an antibiotic treatment. To learn more bout specific pathogen-DNA isolation from blood and other body fluids click here.

What is the difference between SepsiTest™ and other sepsis tests?

>> SepsiTest™ takes an approach very different from other PCR-based sepsis tests:

1. Not biased by free DNA: Assays like SeptiFast are biased by free circulating DNA. These tests can’t differentiate between acute infections and free circulating bacterial DNA.

2. Broad-range test: Our competitors test for a limited panel of strains. Unfortunately this leads to false-negative results due to infections not covered by the panel. Since SepsiTest™ uses a broad-range approach all sepsis-causing pathogens are detected and identified (click here for an updated list).

3. Direct approach: In contrast to many competitors testing for positive blood cultures, SepsiTest™ analyses whole blood and therefore is independent on the growth of pathogens.

4. Two step approach: Routine sepsis PCR diagnostics leads to a positivity rate of 25%-30%. In the first step SepsiTest™ screens for PCR-positive blood samples. PCR-positive samples are subsequently identified for the strain. This leads to an economic allocation of labor and reagents.

What is the main criticism about sepsis PCR?

>> Too expensive, too laborious. Molzym recommends not replacing blood culture by sepsis PCR. The intended use of SepsiTest™ is the identification of pathogens within septicaemic samples being blood culture-negative. For a cost/benefit-analysis of SepsiTest™, please contact This e-mail address is being protected from spam bots, you need JavaScript enabled to view it .

What is the main criticism about SepsiTest™ ?

>> For sequence identification, a sequencer is required. Unfortunately, the broad range of sepsis-causing pathogens can’t be identified using a limited panel of strains. Therefore only a broad-range approach covering all relevant pathogens can lead to reliable results. The fact that, in the blood of critically ill patients, a considerable list of species is being found that is not covered by other multiplex panel PCR (click here for an updated list) underlines the necessity of using universal PCR (SepsiTest™). Today, sequencers are available not more expensive than a real-time PCR machine.

Is SepsiTest™ approved for in vitro diagnostic use?

>>Yes. SepsiTest™ has received CE-IVD marking according to the European in-vitro diagnostic directive EN 98/79 EC.

Does the use of SepsiTest™ require special equipment?

>> No. You need standard molecular biology tools, including a PCR hood, bench top microfuge, a PCR cycler and pipettes. Any Sanger-based sequence analysis system can be used for identification. For detailed information on DNA-free consumables please inquire.

What sample volume is required for SepsiTest™ sepsis testing?

>> Just 2x 1 ml of sample is required.

Is SepsiTest™ available also in the U.S.?

>> Yes. SepsiTest™ currently is available for research-use-only in the US and Canada. You may order directly through this website or our distributor. For a distributor overview, click here.

Trademarks: SepsiTest is a trademark of Molzym, Germany; Septifast is a trademark of Roche Diagnostics