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



Ustar Biotechnologies (Hangzhou) Ltd. Molecular Testing Anywhere

  1. EasyNAT® SYSTEM
  2. Fast Screening
  3. Primary Diagnosis


MultNAT®SYSTEM Therapy-Oriented Diagnosis

• Helicobacter pylori • Feline herpes virus
• Feline calicivirus
• Feline mycoplasma
• TP
• Mycoplasma
• COVID-19
• Flu A/B
• LP
• Parainfluenza
• Salmonella
• L. monocytogenes
• S.aureus
• Vibrio cholerae


  1. Comparing with RT-PCR : Sensitivity ≥ 95.4%
  2. Specificity ≥ 99.8%
  3. Sensitivity 95.413%
  4. Specificity 99.803%
  5. Positive Likelihood Ratio 484.697
  6. Negative Likelihood Ratio 0.046
  7. Positive Predictive Value 99.048%
  8. Negative Predictive Value 99.023%
  9. 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

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)

  1. Biologically safe
  2. All-in-one sealed cartridge
  3. Self-contained sputum container
  4. Free-of-xylene paraffin section pretreatment process
  5. 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.”
  6. Of the 169 PTB patients
  7. Methodology EasyNAT Smear Culture Xpert
  8. Sensitivity 72.19% 32.54% 53.85% 61.54%
  9. Of the 91 patients with culture-positive outcomes
  10. Methodology EasyNAT Smear Xpert
  11. 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)