Leucia immune
Manufactured by Sultan lab, Netherlands - Leuciaimmune.com
Device identification number
2931
CE Marking
×No
HSC common list (RAT)
×No
Format
Manual
Physical Support
Card, Lateral flow, Strip
Target type
Antibody, Antigen, IgA, IgG, IgM
Targets
angiotensin-converting enzyme 2, envelope protein, spike protein
Specimen
Plasma, Saliva, Whole blood with anti-coagulants
Cross-reactivity (pathogens tested)
Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Chlamydia Pneumoniae, Hepatitis A Virus (HAV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Herpes Simplex (HSV), MERS-CoV, SARS-CoV
Lineages detected
B.1.1.529 (Omicron)
Commercial Status
In development
Last Update
2022-08-24 09:08:01 CET
Comments
We develope as well lens with filters to be attached to the mobile to capture digital information using our developed application on offline service with low use data transfer in case the client want to share with high health care professional,just in 5 minutes and with strip as screen loaded with our design antigen to detect viral infections with strain detection and sequence of sample by digital capture beside cancer kit for detection of cancer and type and activity and other kit for antibiotics resistance for kids and adults
Assay Type
Other ()
Self Test
Yes
Reader Required
Yes
Subcategory
Sample collection device
Method
Other ()
Measurement
Other ()
Time
5 minutes
Subclass
Capture
LOD
Unlimited
Calibration
Not evaluated
Analysis of cross reactivity
Not evaluated
False positives
Not present under testing
False negatives
Not present under testing
Precision
Evaluated
Accuracy
90 % (Antigen)
Accuracy
80 % IgA
Accuracy
80 % IgM
Accuracy
90 % IgG
Reproducibility
Not evaluated
Robustness
Not evaluated
Clinical Sensitivity
90 % IgG
Clinical Sensitivity
80 % IgM
Clinical Sensitivity
80 % IgA
Clinical Sensitivity
90 % (Antigen)
Clinical Specificity
90 % IgG
Clinical Specificity
80 % IgM
Clinical Specificity
80 % IgA
Clinical Specificity
90 % (Antigen)
Type of antigen
Spike protein
The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements