Sophonix Co., Ltd. of Beijing at MEDICA 2020 in Düsseldorf -- MEDICA - World Forum for Medicine
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Sophonix Co., Ltd.

Rm 19A-301, 8# Liangshuihe 2nd St., Eco- nomical & Technological Development Zone, 100176 Beijing
China

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Contact

Jiao Wei

Rm 19A-301
8# Liangshuihe 2nd Street
Economical&Technological Development Zone
100176 Beijing, China

Phone
+8618810637270
+8601067898607

Email
info@sophonix.net

Yaxin Yu

Rm 19A-301
8# Liangshuihe 2nd Street
Economical&Technological Development Zone
100176 Beijing, China

Phone
+8613512469051
+8601067898607

Email
info@sophonix.net

Our products

Product category: Diagnostic rapid tests

Automated Chemiluminescence Immunoassay Product Line

  • The chemiluminescence immunodiagnostic product line consists of MS-Fast/ Aceso 80A/ MS-Fast pro 80/160/240 series instruments and compatible magnetic particle chemiluminescence reagent kits.
  • The detection items cover a wide range of fields including: Traumatic Brain Injury (TBI)/ SARS-CoV-2 IgG/ SARS-CoV-2 IgM/ SARS-CoV-2 Antigen (S1 protein)/ Cytokine Storm/ Alzheimer Disease/  Tumor markers/ Cardiovascular & Cerebrovascular Disease/ Maternal and Child Care/ Inflammation markers/ Thyroid Function/ Diabetes/ Gonadal Hormone/ Hypertension/ Gastric Function/ Bone Metabolism, etc.
  • The serials systems realized miniaturization, fully automatic, no fluid system, daily maintenance-free; and are designed for laboratories with small-medium-large daily test volume. The test results can be obtained in as short as 17 minutes .
  • The reagent kits adopts the single-test packaging and pre-installed all consumables, as Tip-head, wash buffer, etc. The magnetic particle chemiluminescence immunoassay method guarantee the sensitivity and specificity higher and the results more precise.
  • MS-FAST analyzer and related reagent kits, including SARS-CoV-2 IgG/ IgM/ S1 protein have already obtained CE/ FDA (EUA) certificate and White list from China's Ministry of Commerce.

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Product category: Diagnostic rapid tests

Pathological Diagnosis Product Line

  • The pathological diagnosis product line is composed of Ultra 60 and Ultra 30 automatic immunohistochemical staining machines.
  • The instruments realize the automatic operation of pathological immunohistochemistry, provide strong support to ensure the accuracy of pathological diagnosis, and are widely used in pathology departments and independent inspections of major hospital centers. 
  • Ultra 60 can stain 60 slides within 2.5 hours; Ultra 30 can stain 30 slides within 3 hours.

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Product category: Polymerase chain reaction (PCR)

LAMP Isothermal Nucleic Acid Amplification System (for SARS-CoV-2 & Influenza A/B)

  • LAMP technology is employed in the GM-Fast 60 system----Isothermal Nucleic Acid Amplification Analyzer.
  • With a special high-activity nucleic acid amplification enzyme, the reaction is  performed under 65℃ and is finished within 20 minutes.
  • The operation is simple and can be used in a variety of detection sites to realize rapid quantitative detection of various types of samples. The wide range of application scenarios include central laboratories, hospital clinical departments, outpatient clinics, emergency departments, CDCs, entry and exit/ports, etc. 
  • The  instrument could be used for rapid detection of pathogens, especially for the infectious diseases, such us the SARS-CoV-2 Nucleic Acid Testing.
  • Compatible reagents:
  1. SARS-CoV-2
  2. Influenza A
  3. Influenza B
  4. RS (respiratory syncytial) Virus
  • Sample Type: Nasopharyngeal swab, Sputum, Whole blood, Serum, Plasma.
  • Operating Steps:
  1. Take samples and blending:nasopharyngeal swab;
  2. Nucleic acid amplification test within 20 mins;
  3. Reading results.

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Product category: Polymerase chain reaction (PCR)

Compatible Consumable Items

We offer the compatible reagents for virus nucleic acid detection as below:
A. Virus preservation fluid:
(1) Non-inactivating preservation fluid-Hank's preservation fluid
  • The virus can remain active and can be used for nucleic acid detection or virus isolation;
  • After adding the swab, it should be kept in refrigerator and tested as soon as possible.
  • Will not inhibit the PCR reaction and can be matched with one-step direct amplification reagents.
(2) Inactivating preservation fluid
  • Guanidine salt
The virus can be lysed and inactivated instantaneously without heating inactivation, which reduces the risk of sampling;
The viral nucleic acid can be stored stably at room temperature for 2 weeks.
  • Non-guanidine salt
The virus can be inactivated instantaneously without heating inactivation, which reduces the risk of sampling;
The viral nucleic acid can be stored stably at room temperature for 2 weeks;
Will not inhibit the PCR reaction and can be matched with one-step direct amplification reagents.
  • Direct amplification preservation fluid
The virus can be inactivated instantaneously, which reduces the risk of sampling;
The viral nucleic acid can be stored stably at room temperature for 48 hours;
It can be directly added to the nucleic acid amplification system as a template.
B. Nucleic acid extraction reagent
(1) Column type (manually)
(2) Magnetic beads (normal, 40 minutes)
(3) Magnetic beads (fast, 8 minutes)
(4) Nucleic acid release agent (extraction-free reagent)
C. LAMP isothermal amplification reagent for:
SARS-CoV-2,
Influenza A/B virus,
Respiratory Syncytial (RS) Virus.

(1)Fluorescence method
(2)Turbidity method
(3)Color rendering method
(4)Fluorescence+color rendering method
D. Nucleic Acid Erasol
E. Proteinase K

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Product category: Diagnostic rapid tests

SARS-CoV-2 IgM/IgG Antibody Rapid Test (Colloidal gold method)

+ Specification: 25 tests/kit

+ Storage conditon: 5-25℃

+ Sample Type: Whole blood, Serum, Plasma.

+ Intended Use:
* It is widely accepted that nucleic acid and antigen are early markers which can be detected during the acute phase of infection, the RT-PCR kit is used to confirm the diagnosis of COVID-19.
* Then IgM provides the first line of defence during viral infections, followed by the generation of adaptive, high affinity IgG responses for long term immunity and immunological memory.
* Therefore, testing of COVID-19 IgM, IgG or total antibodies are effective methods for the diagnosis of COVID-19.
* Furthermore, detection of COVID-19 IgM antibody tends to indicates a recent exposure to SARS-CoV-2, whereas detection of COVID-19 IgG antibody indicates a later stage of infection.
* Thus, IgG and IgM antibody test could provide information on the stage of infection with high sensitivity and specificity.

+ Operating Steps:
1. remove the test cassette from sealed foil pouch;
2. get finger blood by lancet;
3. add 10ul blood+ 2 drops buffer;
4. result reading within 10 minutes.

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Product category: Diagnostic rapid tests

SARS-CoV-2 Antigen Rapid Test Kit (FIA)

Specification: 25 tests/kit
Storage condition: 5-25℃

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Product category: Diagnostic rapid tests

SARS-CoV-2 IgG/ IgM Antibody Test Kit (Magnetic Particle Chemiluminescence Method)

* Intented Use: Sophonix SARS-CoV-2 IgG or IgM Antibody Test is a chemiluminescent immunoassay intended for the qualitative detection of antibodies IgG or IgM to 2019 novel coronavirus (SARS-CoV-2) in serum specimens from individuals suspected of COVID-19 by a healthcare provider.

* Testing Principle: Sophonix SARS-CoV-2 IgG or IgM Antibody Test uses an indirect method to determine the presence of SARS-CoV-2 IgM antibodies in a human serum sample.

* Testing Procedure
1. Unpack the reagent kit;
2. Add 80ul sample in the first well of strip;
3.  Insert strip to reagent rack and put rack in the instrument;
4. Reading result.

* Sample Type: Serum only.

* Specification: 10 tests/kit, 40 tests/kit, 60 tests/kit

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Product category: Diagnostic rapid tests

SARS-CoV-2 Antigen Test Kit (Magnetic Particle Chemiluminescence Method)

* Intended Use:
    This kit is used to qualitatively detect the SARS-CoV-2 Antigen in human nasopharyngeal swab or sputum samples in vitro.

* Test Principles:
    The kit  uses the direct sandwich technique using two monoclonal antibodies method to determine the antigen of SARS-CoV-2.

* Testing Procedure:
1. Unpack the reagent kit;
2. Add 80ul sample in the first well of strip;
3. Insert strip to reagent rack and put rack in the instrument;
4. Reading result.

* Sample Type: Nasopharyngeal swab, Sputum

* Specification: 10 tests/kit, 40 tests/kit, 60 tests/kit;

* Storage Condition: 2-8℃

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Product category: Polymerase chain reaction (PCR)

SARS-CoV-2 RNA Test (RT-PCR method)

* Testing Method: It is a real-time PCR test intended for the qualitative detection of SARS-CoV-2 nucleic acid in oropharyngeal swab, nasopharyngeal swabs, anterior nasal swab and mid-turbinate nasal swab, and sputum samples from patients suspected of COVID-19 by their healthcare providers.

*Testing Principle: The kit is base on a real-time fluorescent PCR platform, using RNA reverse transcription, polymerase chain reaction and  TaqMan probe technology to target the highly conserved regions of the ORF1ab gene and N gene of SARS-CoV-2.

* Testing Procedures:
1. Sample preparation;
2. Reagent preparation;
3. Sample loading;
4. PCR amplification;
5. Set the instrument amplification program and instrument parameters;
6. Result analysis.

* Sample Type:  Oropharyngeal swab, nasopharyngeal swabs, anterior nasal swab and mid-turbinate nasal swab, and sputum.

* Specification: 50 tests/kit, 100 tests/kit

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Product category: Diagnostic rapid tests

TBI (Traumatic Brain Injury) Test Kit (Magnetic Particle Chemiluminescence Method)

GFAP & PGP 9.5 (UCH-L1)
  1. GFAP is a cytoskeleton protein that provides structural support for astrocytes in the brain.
  2. PGP 9.5 mainly exists in the brain nerves and is related to the regulation of cellular proteins.
  3. GFAP & PGP 9.5 enter the bloodstream within 1 hour of brain trauma.
  4. Results of GFAP & PGP 9.5 can be obtained within 30 minutes .    
* Specification: 10 tests/kit, 40 tests/kit, 60 tests/kit         
* Storage Condition: 2-8℃

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About us

Company details

  • Sophonix Co., Ltd. was established in July 2017 and is located in Beijing Economical and Technological Development Zone. The company has established dual R&D centers in California and Beijing. It is a modern biotechnology company dedicated to in vitro diagnostics (IVD), integrating R&D, production, sales and  after sale services, etc.
  • The company has a complete product portfolio of independent intellectual property rights, including: automatic chemiluminescence immunoassay analyzers (CLEIA method), pathological diagnosis system (Automatic Immunohistochemical Staining Machine) and molecular diagnosis system (Isothermal Nucleic Acid Amplification Analyzer, LAMP technology) and the compatible reagents, which are suitable for POCT rapid detection sites. 
Applicable fields:

1. COVID-19 pandemic:
  • SARS-CoV-2 nucleic acid test (RNA & LAMP technology);
  • SARS-CoV-2 antigen test (CLEIA & Colloidal gold methods);
  • SARS-CoV-2 IgG/IgM antibody test (CLEIA & Colloidal gold methods);
2. Regular laboratory test:
  • Traumatic brain injury (TBI): GFAP(glial fibrillary acidic protein), PGP9.5/UCH-1;
  • Cytokine storm: IL-1(α,β),/ 2/ 6/ 8/ 10/ 15/ 18/ 33; IFN-γ; TNF-γ, etc.;
  • Gonadal Hormone: AMH, PRL, TSH, etc.;
  • Cardiovascular & Cerebrovascular diseases: CKMB, cTnI, Myo, NT-proBNP,  D-dimer, LP-PLA2, ST2;
  • Thyroid function: TT3, TT4, fT3, fT4, TGAB, TPOAB;
  • Alzheimer Disease: TAU protein, P-TAU-181, Amyloid β-protein(1-42)
  • Inflammation: PCT, SAA, hs-CRP, IL-6;
  • Diabetes: C-Peptide, HbA1c, IAA, Insulin;
  • Gastric Function: PG-I, PG-II, G-17;
  • Bone Metabolism: PTH, 25-OH-VD, CT, Elecsysβ-CrossLaps;
  • Tumor marker: AFP, CEA, etc.

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Company data

Sales volume

1-9 Mio US $

Export content

max. 50%

Number of employees

100-499

Foundation

2017

Area of business
  • Electromedical equipment / Medical Technology
  • Laboratory Equipment
  • Diagnostics