EasyNAT Reagents
| U20223 | CE marked | Diagnostic Kit for Novel-Coronavirus(2019-nCoV) RNA (Isothermal Amplification-Real Time Fluorescence Assay) |
| U202018-20 | CE marked | EasyNAT SARS-CoV-2 Variants ( S gene ΔHV69-70 & N501Y) Assay |
| U202020-20 | CE marked | EasyNAT SARS-CoV-2 Beta Variant Assay |
| U202019-20 | CE marked | EasyNAT SARS-CoV-2 Delta Variant Assay |
| U202023-20 | CE marked | EasyNAT SARS-CoV-2 Omicron Variant Assay |
| U202024-20 | CE marked | EasyNAT SARS-CoV-2/SARS-CoV-2 Delta Variant Assay |
| U20103 | CE marked | Diagnostic Kit for M.tuberculosis Complex DNA(CPA Assay) |
| U201002-20 | CE marked | EasyNAT MTC/NTM Assay |
| U20201 | CE marked | Diagnostic Kit for Mycoplasma Pneumoniae DNA (CPA Assay) |
| U20206 | CE marked | EasyNAT Rapid Flu Assay |
| U20208 | CE marked | EasyNAT Rapid RSV Assay |
| U20209 | CE marked | EasyNAT BP Assay |
| U202004-20 | CE marked | EasyNAT BP erythromycin Resistance Assay |
| U202006-20 | CE marked | EasyNAT LP Assay |
| U20302 | CE marked | Diagnostic Kit for Mycoplasma Genitalium DNA (CPA Assay) |
| U20304 | CE marked | Diagnostic Kit for HSV 1&2 DNA (CPA Assay) |
| U20303 | CE marked | EasyNAT UU Assay |
| U203005-20 | CE marked | EasyNAT UU/MH Assay |
| U20311 | CE marked | EasyNAT GBS Assay |
| U203002-20 | CE marked | EasyNAT Human Parvovirus B19 Assay |
| U203004-20 | CE marked | EasyNAT TP Assay |
| U203009-20 | CE marked | EasyNAT TV Assay |
| U203011-20 | CE marked | EasyNAT HPV 16/18 Assay |
| U203012-20 | CE marked | EasyNAT HPV 6/11 Assay |
| U203001-20 | In registration | N/A |
| U203010-20 | CE marked | EasyNAT Malaria Assay |
| U202028-20 | CE marked | EasyNAT Monkeypox Virus Assay |
| CE marked | EasyNAT Monkeypox Virus Assay 2 | |
| CE marked | EasyNAT Calicivirus Assay | |
| CE marked | EasyNAT Borrelia burgdorferi Assay | |
| CE marked | EasyNAT Rotavirus Assay | |
| CE marked | EasyNAT Leptospirosis Assay | |
| CE marked | EasyNAT Dengue Virus Assay | |
| CE marked | EasyNAT Measles Virus Assay | |
| CE marked | EasyNAT Poliovirus Assay | |
| CE marked | EasyNAT Candida Albicans Assay | |
| CE marked | EasyNAT Acinetobacter Baumannii Assay | |
| CE marked | EasyNAT Shiga toxin-producing E. coli Assay | |
| CE marked | EasyNAT Listeria Monocytogenes Assay | |
| CE marked | EasyNAT Salmonella Assay | |
| CE marked | EasyNAT Vibrio Cholerae Assay | |
| CE marked | EasyNAT Vibrio Parahaemolyticus Assay | |
| CE marked | EasyNAT Streptococcus Pneumoniae Assay | |
| CE marked | EasyNAT Staphylococcus Aureus Assay | |
| CE marked | EasyNAT Neisseria Gonorrhoeae Assay | |
| CE marked | EasyNAT Haemophilus Influenzae Assay | |
| CE marked | EasyNAT Klebsiella Pneumoniae Assay | |
| CE marked | EasyNAT Pseudomonas Aeruginosa Assay | |
| CE marked | EasyNAT Shigella Assay
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Ustar Biotechnologies (Hangzhou) Ltd. Molecular Testing Anywhere
- EasyNAT® SYSTEM
- Fast Screening
- Primary Diagnosis
PortNAT® SYSTEM
MultNAT®SYSTEM Therapy-Oriented Diagnosis
• Helicobacter pylori • Feline herpes virus
• Feline calicivirus
• Feline mycoplasma
• HIV
• TP
• CT/NG
• GBS
• Mycoplasma
/Chlamydia
• COVID-19
• MTC/NTM
• Flu A/B
• RSV
• LP
• Parainfluenza
virus
• Salmonella
• L. monocytogenes
• S.aureus
• STEC
• Vibrio cholerae
Specifications
- Comparing with RT-PCR : Sensitivity ≥ 95.4%
- Specificity ≥ 99.8%
- Sensitivity 95.413%
- Specificity 99.803%
- Positive Likelihood Ratio 484.697
- Negative Likelihood Ratio 0.046
- Positive Predictive Value 99.048%
- Negative Predictive Value 99.023%
- Accuracy 99.028%
General Hospital Jesenice (Slovenia)
Clinical Hospital Rijeka (Croatia)
Clinical Performance-China
EasyNAT® Certificate & Registration
- U.S. FDA
- European Union CE
- Singapore HSA
- Australia TGA
- Brazil ANVISA
- Philippines FDA
- Thailand
- Peru
- Nigeria NAFDAC
- Malaysia MDA
- China NMPA
- Israel
EasyNAT® COVID-19 l Targets：ORF1ab, N gene l Sample type: swab, sputum l LOD≤200 copies/mL l Sensitivity ≥ 98.0%, specificity ≥ 99.6% l All in one cartridge: sample-in, result- out, within 20 min l Ambient transportation: -25~30℃
l Sample type: sputum, BALF, urine, paraffin-embedded tissue sample, pus, CSF, gastric aspirate, ascites with hydrothoraxl LOD ≤100 CFU/mL
l Sensitivity ≥ 96.6%, specificity≥98.6%l Integrated testing：sample-in, result-out, result in65minl Ambient transportation：-25~30℃
EasyNAT® MTC: Workflow37
① Add lysis buffer
② Autoclave 10 min
③ Add into cartridge
④ Detection
⑤Report result
Sputum
Paraffin
section
① Collect in a
sputum container
② Liquefy without opening lid
EasyNAT® MTC: Highlights
Test anytime Independent modules, providing instant testing for everysinglesampleFast testing Optimized sample pre-treatment, shortened turnaround time (TAT)
Point-of-care testing Applicable for tent hospital, airport, and mobile van (lab)
- Biologically safe
- All-in-one sealed cartridge
- Self-contained sputum container
- Free-of-xylene paraffin section pretreatment process
- 39Clinical Evaluation: Sputum“EasyNAT could be used as an initial test for PTB diagnosis due to its simplicity, rapid turnaround time, high sensitivity, and low cost.”
- Of the 169 PTB patients
- Methodology EasyNAT Smear Culture Xpert
- Sensitivity 72.19% 32.54% 53.85% 61.54%
- Of the 91 patients with culture-positive outcomes
- Methodology EasyNAT Smear Xpert
- Sensitivity 93.40% 56.04% 91.21%
• M. Kansas, M. Avium, M. intracellular, M. chelonae
• M. Abscess, M. Fortuitans, M. Smegmatis, M. Marseillae
• M. scrofula, M. Gordon, M. toad, M. ulcerate
• M. mariae, M. haemophilus, M. apes, M. gastroticus
OXA FAM OXA-48（K.pneumoniae） 100 CFU/mL OXA-48（E.Coli）50CFU/mLKPC HEX KPC-3（K.pneumoniae） 50CFU/mL KPC-4（K.pneumoniae）100CFU/mLVIM ROX VIM-4（E.Coli） 50CFU/mL VIM-1（K.pneumoniae）50CFU/mLB IMP FAM IMP-1（E.Coli） 50CFU/mL IMP-2（P.aeruginosa）100CFU/mLC
NDM FAM NDM-1（K.pneumoniae） 200CFU/mL NDM-2（A.baumannii）50CFU/mLK.pneumoniae HEX 400 CFU/mL /
A.baumannii ROX 400 CFU/mL /P.aeruginosa FAM 400 CFU/mL /
E.Coli ROX 400 CFU/mL /
MultNAT® Carba‐R and Four Pathogens PCR Assay (RUO)