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Sophonix Co., Ltd.
Rm 19A-301, 8# Liangshuihe 2nd St., Eco- nomical & Technological Development Zone,
100176
Beijing
China
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 range of products
Product categories
- 03 Diagnostic tests
- 03.02 Immunochemistry testing, immunology testing
- 03.02.02 Diagnostic rapid tests
Diagnostic rapid tests
- Automated Chemiluminescence Immunoassay Product Line
- Pathological Diagnosis Product Line
- SARS-CoV-2 IgM/IgG Antibody Rapid Test (Colloidal gold method)
- SARS-CoV-2 Antigen Rapid Test Kit (FIA)
- SARS-CoV-2 IgG/ IgM Antibody Test Kit (Magnetic Particle Chemiluminescence Method)
- SARS-CoV-2 Antigen Test Kit (Magnetic Particle Chemiluminescence Method)
- TBI (Traumatic Brain Injury) Test Kit (Magnetic Particle Chemiluminescence Method)
- Fecal Occult Blood Test (Colloidal Gold Method)
- 03 Diagnostic tests
- 03.06 Genetic testing, molecular diagnostics
- 03.06.03 Polymerase chain reaction (PCR)
Polymerase chain reaction (PCR)
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.
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.
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:
- SARS-CoV-2
- Influenza A
- Influenza B
- RS (respiratory syncytial) Virus
- Sample Type: Nasopharyngeal swab, Sputum, Whole blood, Serum, Plasma.
- Operating Steps:
- Take samples and blending：nasopharyngeal swab;
- Nucleic acid amplification test within 20 mins;
- Reading results.
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 viral nucleic acid can be stored stably at room temperature for 2 weeks.
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.
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
F. Sample Collecting & Transporting & Adding Set
Sample Types: Nasopharyngeal swab; Sputum
Operating Steps:
Step 1. sample collection
Step 2. sample spinning
Step 3. sample adding
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.
- Guanidine salt
The viral nucleic acid can be stored stably at room temperature for 2 weeks.
- Non-guanidine salt
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 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
F. Sample Collecting & Transporting & Adding Set
Sample Types: Nasopharyngeal swab; Sputum
Operating Steps:
Step 1. sample collection
Step 2. sample spinning
Step 3. sample adding
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.
+ 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.
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
* 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
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℃
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℃
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
*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
Product category: Diagnostic rapid tests
TBI (Traumatic Brain Injury) Test Kit (Magnetic Particle Chemiluminescence Method)
* GFAP & PGP 9.5 (UCH-L1)
* Storage Condition: 2-8℃
- GFAP is a cytoskeleton protein that provides structural support for astrocytes in the brain.
- PGP 9.5 mainly exists in the brain nerves and is related to the regulation of cellular proteins.
- GFAP & PGP 9.5 enter the bloodstream within 1 hour of brain trauma.
- Results of GFAP & PGP 9.5 can be obtained within 30 minutes .
* Storage Condition: 2-8℃
Product category: Diagnostic rapid tests
Fecal Occult Blood Test (Colloidal Gold Method)
* What is FOB test?
- This product is used for qualitative detection of hemoglobin in human fecal samples in vitro to evaluate gastrointestinal bleeding
* What is its Clinical Application?
1.In the early stage of digestive tract cancer: 20% of the patients can have occult blood test positive;
2.Gastrointestinal bleeding and peptic ulcer: the FOB test are mostly positive;
3. Other disease: Dysentery, rectal polyps, hemorrhoids, etc.
* How to operate?
1. Collect sample;
2. Blending in the tube;
3. Result can be read in 5-15 mins.
- This product is used for qualitative detection of hemoglobin in human fecal samples in vitro to evaluate gastrointestinal bleeding
* What is its Clinical Application?
1.In the early stage of digestive tract cancer: 20% of the patients can have occult blood test positive;
2.Gastrointestinal bleeding and peptic ulcer: the FOB test are mostly positive;
3. Other disease: Dysentery, rectal polyps, hemorrhoids, etc.
* How to operate?
1. Collect sample;
2. Blending in the tube;
3. Result can be read in 5-15 mins.
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.
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);
- 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.
Company data
Sales volume1-9 Mio US $
Export contentmax. 50%
Number of employees100-499
Foundation2017
Area of business- Imaging and diagnostics / medical equipment & devices
- Laboratory equipment
- Diagnostics