As a global leader in the field of high-quality IVD testing, Fujirebio has more than 50 years’ accumulated experience in the conception, development, production and worldwide commercialization of robust IVD products.
In a reply to the Covid-19 pandemic impacting the world since early 2020, Fujirebio plays an important role as a healthcare partner, offering various testing solutions that are used across the world today to support fast and trustworthy diagnosis.:
- A qualitative molecular rapid detection kit based on real-time fluorescent reverse transcription isothermal amplification and testing of naso- or oropharyngeal swab samples. This assay gives results within 75 minutes and does not require RNA extraction.
- A high-sensitive antigen assay running on our fully automated chemiluminescent platform, capable of testing both nasopharyngeal swab fluid or saliva samples and giving fast results, in up to 25 minutes.
- A lateral flow-based rapid antigen test that does not require any special equipment. This portable single assay device evaluates nasopharyngeal swab fluid, it uses a simple procedure and has a short time to result, of only 30 minutes.
Furthermore, thanks to our long-lasting and extensive experience in lung disease testing we also offer associated testing solutions that allow to predict disease severity in patients infected with SARS-CoV-2.
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Our current Covid-19 testing solutions:
iAMP COVID-19 Detection Kit
Qualitative nucleic acid detection kit for IVD testing of naso- or oropharyngeal swab samples. It is based on real-time fluorescent reverse transcription isothermal amplification and eliminates the need for RNA extraction. The iAMP COVID-19 Detection Kit can be run on a Real-Time PCR PowerGene 9600 Plus or any other qPCR automate capable of measuring fluorescence in FAM/HEX channel in real-time.
An immunochromatographic rapid test for IVD use that detects the SARS-CoV-2 antigen in nasopharyngeal swab fluid with high sensitivity and specificity and without any special equipment. This allows for effective surveillance that prioritize accessibility, frequency and sample-to-answer time.
Lumipulse® G SARS-CoV-2 Ag
Immunoreaction cartridges for IVD use with the LUMIPULSE G system for detection and quantitative measurement of SARS-CoV-2 nucleocapsid protein antigen in human nasopharyngeal swab fluid or saliva. The assay utilizes proven CLEIA (chemiluminescent enzyme immunoassay) technology. Lumipulse G SARS-CoV-2 Ag was the first high-sensitive antigen assay launched on a fully automated chemiluminescent platform.
Lumipulse G KL-6 (Krebs von den Lungen)
Immunoreaction cartridges for IVD use with the LUMIPULSE G System for the quantitative measurement of sialylated carbohydrate antigen, KL-6 in human serum or plasma.
IL-6 (Interleukin) LPG
Immunoreaction cartridges for research use only with the LUMIPULSE G system for the quantitative measurement of IL-6 in human serum or plasma.
Lumipulse G B•R•A•H•M•S PCT
Immunoreaction cartridges for IVD use with the LUMIPULSE G system for the quantitative determination of procalcitonin (PCT) in human serum or plasma.