1. Respiratory infections
Vivalytic SARS-CoV-2 DT 06
Vivalytic SARS-CoV-2 DT, Flu A/B, RSV 08
Vivalytic Bordetella 10
2. Gastrointestinal infections
Vivalytic C. difficile 12
Vivalytic Norovirus 14
Vivalytic Noro-, Rotavirus, C. diff 16
3. Urinary tract infections
Vivalytic UTI* 18
4. Sexually transmitted infections
Vivalytic STI 20
Vivalytic MG,MH, UP/UU 22
Vivalytic MPXV* 24
5. Nosocomial infections
Vivalytic MRSA/SA 26
Vivalytic C. auris 28
6. Meningitis
Vivalytic Bacterial Meningitis 30
*Currently under development. Available as Research Use Only (RUO). Not for use in diagnostic procedures.
7. Respiratory Infections
Vivalytic SARS-CoV-2 DT
Overview
| Specification | Details |
|---|---|
| Detectable Pathogen | SARS-CoV-2 virus |
| Targets | Dual target (E-gene & N-gene) |
| Detection Method | Qualitative real-time PCR |
| Sample Material | Nasopharyngeal swabs Oropharyngeal swabs Lolly-saliva swabs |
| Time-to-Result | Approx. 30 minutes |
| Field of Application | Symptomatic and asymptomatic patients Professional and laboratory use Near Patient Testing |
| Sample Volume | 300 μL per test |
| Transport Medium (1 ml) | eNAT® transport medium (Copan) |
Vivalytic SARS-CoV-2 DT, Flu A/B, RSV Diagnostic Overview
| Specification | Details |
|---|---|
| Detectable Pathogens | SARS-CoV-2 virus (E-gene) Influenza A virus (M-gene) Influenza B virus (NP-gene) Human Respiratory Syncytial Virus (RSV) (F-gene) |
| Detection Method | Qualitative real-time PCR |
| Sample Material | Nasopharyngeal swabs Oropharyngeal swabs Lolly-saliva swabs |
| Time-to-Result | Approx. 60 minutes |
| Field of Application | Symptomatic patients Professional and laboratory use Near Patient Testing |
| Sample Volume | 300 μL per test |
| Compatible Transport Media (1 ml) | eNAT® Transport Medium (Copan) UTM® Universal Transport Medium™ (Copan) Puritan™ UniTranz-RT Transport System (Puritan) SIGMA VIROCULT® (Medical Wire & Equipment) |
Vivalytic Bordetella Diagnostic Overview
| Specification | Details |
|---|---|
| Detectable Pathogens | Bordetella pertussis (gene target IS481) Bordetella parapertussis (gene target pIS1001) Bordetella holmesii (gene targets IS481, hIS1001) |
| Detection Method | Qualitative real-time PCR |
| Sample Material | Nasopharyngeal swabs |
| Time-to-Result | Approx. 47 minutes |
| Field of Application | Symptomatic patients Professional and laboratory use |
| Sample Volume | 300 μL per test |
| Transport Medium (1 ml) | eNAT® transport medium (Copan) |
Vivalytic Clostridioides difficile Diagnostic Overview
| Specification | Details |
|---|---|
| Detectable Pathogen | Clostridioides difficile (tcdA/tcdB) |
| Detection Method | Qualitative real-time PCR |
| Sample Material | Soft and liquid stool samples |
| Time-to-Result | Approx. 54 minutes |
| Field of Application | Symptomatic patients Professional and laboratory use |
| Sample Volume | 300 μL per test |
| Transport Medium (2 ml) | eNAT® (Copan) with regular FLOQSwabs® |
Vivalytic Norovirus Overview – Vomiting Bug
| Specification | Details |
|---|---|
| Detectable Pathogens | Norovirus genogroup I/II |
| Detection Method | Qualitative real-time PCR |
| Sample Material | Soft and liquid stool samples |
| Time-to-Result | Approx. 60 minutes |
| Field of Application | Symptomatic patients Professional and laboratory use |
| Sample Volume | 300 μL per test |
| Transport Medium (2 ml) | eNAT® (Copan) with regular FLOQSwabs® |
Vivalytic Noro-, Rotavirus, C. diff Diagnostic Overview
| Specification | Details |
|---|---|
| Detectable Pathogens | Norovirus genogroup I/IIRotavirus Type AClostridioides difficile (tcdA/tcdB) |
| Detection Method | Qualitative real-time PCR |
| Sample Material | Soft and liquid stool samples |
| Time-to-Result | Approx. 60 minutes |
| Field of Application | Symptomatic patientsProfessional and laboratory use |
| Sample Volume | 300 μL per test |
| Transport Medium (2 ml) | eNAT® (Copan) with regular FLOQSwabs® |
Vivalytic UTI* Overview
| Specification | Details |
|---|---|
| Detectable Pathogens – Gram-Negative Bacterial Species | Acinetobacter baumanniiEnterobacter cloacaeEscherichia coliKlebsiella aerogenesKlebsiella oxytocaKlebsiella pneumoniaeMorganella morganiiProteus spp.Providencia stuartiiPseudomonas aeruginosa |
| Detectable Pathogens – Gram-Positive Bacterial Species | Enterococcus faecalisEnterococcus faeciumStaphylococcus aureusStaphylococcus epidermidisStaphylococcus saprophyticusStreptococcus agalactiae |
| Antimicrobial Resistance Genes – Trimethoprim Resistance | dfrA1dfrA5dfrA17dfrA12 |
| Antimicrobial Resistance Genes – Methicillin Resistance | mecA |
| Antimicrobial Resistance Genes – Vancomycin Resistance | vanAvanB |
| Detection Method | Qualitative real-time PCR |
| Sample Material | Native urine |
| Time-to-Result | Approx. 90 minutes |
| Field of Application | Symptomatic and asymptomatic patientsProfessional & laboratory useNear Patient Testing |
| Sample Volume | 300 μL per test |
| Transport Medium | No stabilising medium required |
*Currently under development. Available as Research Use Only (RUO). Not for use in diagnostic procedures.
Vivalytic STI Diagnosis Overview
| Specification | Details |
|---|---|
| Detectable Pathogens | Herpes simplex virus 1 (HSV-1) Herpes simplex virus 2 (HSV-2) Chlamydia trachomatis (CT) Haemophilus ducreyi (HD) Mycoplasma genitalium (MG) Mycoplasma hominis (MH) Neisseria gonorrhoeae (NG) Treponema pallidum (TP) Ureaplasma urealyticum (UU) Trichomonas vaginalis (TV) |
| Detection Method | PCR-based microarray |
| Sample Material | Urine (recommended first void) Urogenital swabs (e.g. vaginal, cervical, urethral) |
| Time-to-Result | Approx. 2 hours 20 minutes |
| Field of Application | Professional and laboratory use Near Patient Testing |
| Sample Volume | 300 μL per test |
| Transport Medium (1 ml) | eNAT® transport medium (Copan) |
| Swab Type | FLOQSwabs® Regular, sterile (Copan) FLOQSwabs® MiniTip, sterile (Copan) |
Vivalytic MG, MH, UP/UU Overview
| Specification | Details |
|---|---|
| Detectable Pathogens | Mycoplasma genitalium Mycoplasma hominis Ureaplasma parvum / Ureaplasma urealyticum |
| Detection Method | Qualitative real-time PCR |
| Sample Material | Urine (recommended first void) Swabs (e.g. vaginal, cervical, urethral, rectal) |
| Time-to-Result | Approx. 60 minutes |
| Field of Application | Symptomatic and asymptomatic patients Professional and laboratory use Near Patient Testing |
| Sample Volume | 300 μL per test |
| Transport Medium (1 ml) | eNAT® transport medium (Copan) |
| Swab Type | FLOQSwabs® Regular, sterile (Copan) FLOQSwabs® MiniTip, sterile (Copan) |
MPXV* Overview
| Specification | Details |
|---|---|
| Detectable Pathogens | Monkeypox VirusOrthopoxvirus species |
| Detection Method | Qualitative real-time PCR |
| Time-to-Result | Approx. 45 minutes |
| Sample Volume | 300 μL per test |
| Transport Medium (1 ml) | eNAT® transport medium (Copan) |
*Currently under development. Available as Research Use Only (RUO). Not for use in diagnostic procedures.
Vivalytic MRSA/SA Overview
| Specification | Details |
|---|---|
| Detectable Pathogens | Methicillin-resistant / methicillin-sensitive Staphylococcus aureus |
| Detection Method | Qualitative real-time PCR |
| Sample Material | Nasopharyngeal swabs Oropharyngeal swabs |
| Time-to-Result | Approx. 55 minutes |
| Field of Application | Symptomatic and asymptomatic patients Professional and laboratory use |
| Sample Volume | 600 μL per test |
| Collection Technology | Cell capture |
| Transport Medium (1 ml) | Liquid Amies / eSwab® Collection Transport System (Copan) |
Vivalytic C. auris Overview
| Specification | Details |
|---|---|
| Detectable Pathogen | Candida auris (ITS2 gene) |
| Detection Method | Qualitative real-time PCR |
| Sample Material | Nasal swabs Bilateral axilla, groin and nasal combination swabs |
| Time-to-Result | Approx. 60 minutes |
| Field of Application | Screening of colonised patients Professional and laboratory use |
| Sample Volume | 300 μL per test |
| Transport Medium (1 ml) | Liquid Amies / eSwab® Collection Transport System (Copan) |
Vivalytic Bacterial Meningitis Overview
| Specification | Details |
|---|---|
| Detectable Pathogens | Escherichia coli Streptococcus agalactiae Haemophilus influenzae Listeria monocytogenes Neisseria meningitidis Streptococcus pneumoniae |
| Detection Method | Qualitative real-time PCR |
| Sample Material | Cerebrospinal fluid (CSF) |
| Time-to-Result | Approx. 56 minutes |
| Field of Application | Symptomatic patients Professional and laboratory use |
| Sample Volume | 300 μL per test |
| Transport Medium (1 ml) | No transport medium |
| Swab Type | FLOQSwabs® Regular, sterile (Copan) FLOQSwabs® MiniTip, sterile (Copan) |
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