Respiratory Tract Infections – Sansure Biotech

S3055E BP – Bordetella Pertussis DNA Diagnostic Kit

yang, rongchang — Wed, 06 Sep 2023 01:24:10 +0000

Brief

Pertussis, also known as whooping cough, is a highly contagious respiratory infection caused by the bacterium Bordetella pertussis. Pertussis spreads easily from person to person mainly through droplets produced by coughing or sneezing. The disease is most dangerous in infants, and is a significant cause of disease and death in this age group.

Sansure kit is used to detect Bordetella pertussis DNA present in the nasopharyngeal swab specimens by applying PCR fluorescence probing technique. The detection result can be used as an aid in the diagnosis of bordetella pertussis.

Parameters

Product features	Parameter
Specimen Types	Nasopharyngeal swab
Technical Platform	Fast release technology Advanced magnetic beads technology
Anti-contamination system	UNG enzyme + dUTP system
Internal Control	Internal control plasmid
PCR Instruments	Mx3000P; ABI 7500; MA-6000; S-Q31A/S-Q31B; S-Q36A
Sensitivity	200 copies/mL
Obtained Certificates	NMPA, CE-IVDD etc.

S3174E HCoV-MERS – Human Coronavirus (MERS) Nucleic Acid Diagnostic Kit

yang, rongchang — Tue, 14 Feb 2023 05:22:07 +0000

Brief

The Human Coronavirus (MERS) is generally detectable in respiratory samples during the acute phase of infection. The Human Coronavirus (MERS) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) can qualitatively detect HCoV-MERS in sputum, alveolar lavage fluid, and throat swabs, the test results can be used to assist in the diagnosis of patients infected with HCoV-MERS, providing a molecular diagnostic basis for coronavirus MERS infection. The test results of this kit are for clinical reference only, and should not be used as the sole criterion for clinical diagnosis. It is recommended to conduct a comprehensive analysis of the condition based on the patient's clinical manifestations and other laboratory tests.

Parameters

Product features	Parameter
Covering Genes	MERS-CoV Orf1b
Specimen Types	Sputum, alveolar lavage fluid, throat swab
Technical Platform	One-tube fast release technology Advanced magnetic beads technology
Internal Control Gene	RNase P
Compatible Instruments	ABI 7500, Stratagene Mx3000P, SLAN®-96P, MA-6000, iPonatic S-Q36A/S-Q31A/S-Q31B
Sensitivity	500 copies/mL
Qualification	CE

S3353E FluA/Flu B – Influenza A/B Virus Nucleic Acid Diagnostic Kit

yang, rongchang — Mon, 05 Dec 2022 07:09:38 +0000

Brief

Influenza Virus is a kind of RNA virus in the Orthomyxoviridae family which leading to human and animal influenza. It causes acute upper respiratory tract infection, spreads rapidly through the air and has periodic pandemics around the world. Human influenza virus are influenza pathogens which can be classified into three types, namely A, B and C. Among them, influenza A is the most harmful, while influenza B and influenza C have weak pathogenicity and are not easy to mutate.

The diagnostic Kit is intended for detection of the Influenza A and Influenza B in oropharyngeal swab from individuals. The test results can be used for the auxiliary diagnosis of respiratory Influenza A/B Virus infection and provide molecular diagnostic basis for Influenza A/B Virus infection.

Parameters

Product features	Parameter
Covering pathogens	Influenza A and Influenza B
Specimen Types	Oropharyngeal swab
Technical Platform	One-tube fast release technology Advanced magnetic beads technology
Compatible Instrument	ABI 7500; MA-6000; SLAN®-96P; QuantGene 9600; iPonatic S-Q31A/S-Q31B
Sensitivity	200 copies/mL
Spec.	48T, 24-P
Qualification	CE

S3363E-12-P TB and RFP – Mycobacterium Tuberculosis Nucleic Acid and Rifampicin Resistance Fluorescence Diagnostic Kit

yang, rongchang — Mon, 05 Dec 2022 06:03:55 +0000

Brief

Mycobacterium tuberculosis (M. tuberculosis) is the pathogen causing tuberculosis, which can invade all organs of the whole body, and pulmonary tuberculosis caused by pulmonary involvement is the most common. Early diagnosis and treatment are crucial measures to effectively control the spread of tuberculosis.

Due to the abuse of antibiotics or the insufficient course of drugs of patients, the sensitivity of patients to drugs weakens or even disappears, resulting in the decreasing or ineffective effect of drugs on pulmonary tuberculosis. According to the types of anti-tuberculosis drugs, drug-resistant tuberculosis can be divided into monoresistance pulmonary tuberculosis, polyresistance pulmonary tuberculosis, multidrug resistance pulmonary tuberculosis and extensively drug-resistant pulmonary tuberculosis. Rifampicin is one of the first-line drugs for the treatment of pulmonary tuberculosis.

The Mycobacterium Tuberculosis and Rifampicin Resistance Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) is a real-time polymerase chain reaction test kit intended for the qualitative detection of the nucleic acid of mycobacterium tuberculosis and rifampicin resistance mutations in human sputum samples. The test results can be used to assist in the diagnosis of TB patients and patients with an increased risk of RFP drug-resistant TB, providing a molecular diagnosis basis for infected patients.

Parameters

Product features	Parameter
Specimen Type	Sputum
Technical Platform	One-tube fast release technology
PCR Instruments	iPonatic Ⅲ (S-Q36A)
Internal Control	RNase P
Limit of detection	Mycobacterium tuberculosis 1,000 Bacteria/mL; Rifampicin resistance 10,000 Bacteria/mL

The kit is registered in Indonesia.

S3016E MP – Mycoplasma Pneumoniae DNA Fluorescence Diagnostic Kit

admin@sansure2021 — Fri, 22 Jul 2022 07:52:56 +0000

Brief

Mycoplasma pneumoniae (MP) is a pathogenic microorganism between bacteria and virus. It is mainly transmitted through buccal and nasal mucus by the air causing respiratory diseases, with the highest incidence in children and adolescents. Respiratory infection has the manifestations of pharyngitis and bronchitis, with a few cases causing infection to the lung. Recently, incidence among infants and children is increasing, therefore, early diagnosis and treatment can decrease the exacerbation of acute pneumonia in children. The development of molecular biology also draws more attention to the fluorescence quantitative PCR technology for the detection of MP-DNA. This diagnostic kit is an in vitro nucleic acid amplification test for the detection of mycoplasma pneumoniae DNA in humansputum and throat swab. It is intended for use as an aid in the diagnosis of an MP infection and providing a molecular-diagnostics-based solution.

Parameters

Product features	Parameter
Specimen Type	Sputum and throat swab
Extraction Platform	One-tube fast release technology
Internal Control	cloning plasmid containing the target gene fragment
PCR Instrument	ABI 7500, SLAN-96P,MA-6000, Roche LightCycler 480, iPonatic S-Q31A&B,S-Q36A
Sensitivity	400 copies/mL
Spec.	48T, 12-P
Qualification	CE

S3066E 6RP – Six Respiratory Pathogens Nucleic Acid Diagnostic Kit

admin@sansure2021 — Fri, 22 Jul 2022 07:40:46 +0000

Brief

Respiratory infections are classified into the upper respiratory tract infections and lower respiratory tract infections. It refer to the pathogens that infect the nose, throat, trachea, bronchi or lungs, which principally cause diseases of tissues and organs outside the respiratory tract, manifested by fever, sore throat, cough, headache and other symptoms. The respiratory tract pathogen has the characteristics of strong infectivity, rapid spread, short incubation period and acute onset, etc. which seriously harm human health. After respiratory infection, symptoms are mostly similar. Sansure six respiratory pathogens joint detection kits can help doctors make differential diagnosis, accurately detect the pathogens that cause symptoms, and formulate treatment plans.

Performance

High sensitivity: Super-cis-nanometer magnetic bead technology; can achieve 500copies/mL
Accurate identification: One test presented six results ; accurate guidance for rational clinical drug use
Whole-process monitoring: Glyceraldehyde-3-phosphate dehydrogenase (GAPDH) human housekeeping gene as internal standard; Monitor the whole process of sampling, nucleic acid extraction and amplification

Parameters

Product features	Parameter
Specimen Type	Nasopharyngeal swabs
Extraction Platform	Advanced magnetic beads technology
Internal Control	lentivirus particles（GAPDH）
PCR Instrument	SLAN-96P, ABI7500
Sensitivity	Influenza A virus: 2.0 TCID₅₀/mL Influenza B virus: 2.0 TCID₅₀/mL Respiratory syncytial virus: 500.0 copies/mL Adenovirus: 500.0 copies/mL Mycoplasma pneumonia: 500.0 copies/mL Human rhinovirus: 500.0 copies/mL
Spec.	24T
Qualification	CE

S3334E ADV – Adenovirus Nucleic Acid Diagnostic Kit

xiaochen, liu — Thu, 02 Jun 2022 01:32:12 +0000

Brief

Acute infectious disease caused by adenovirus, easily affects the mucous membranes of the respiratory and digestive tracts, the conjunctiva of the eyes, the urinary tract and the lymph nodes. The main manifestation is an acute upper respiratory tract infection. The population is generally susceptible, mostly the children. Infants are susceptible to adenovirus pneumonia, which is severe and has a high mortality rate. The source of infection is the patient and the latent infected person. The virus is excreted from the respiratory tract and conjunctival secretions, feces and urine, and is transmitted by airborne droplets, close contact and the feces-oral route. The Adenovirus Nucleic Acid Diagnostic Kit is used for nucleic acid testing of adenovirus in patients suspected of being adenovirus infections (e.g., fever, cough, wheezing, dyspnea, bronchopneumonia, upper respiratory tract infections, lung infections, etc.) or related close contacts, and the results can be used to assist in the diagnosis of adenovirus infection and provide a molecular diagnostic basis for adenovirus infection.

Features

High sensitivity: Detection sensitivity reaches 200 copies/mL.
Quick and easy: Perfectly match Sansure's one-tube fast Sample Release Reagent, easy to operate.
IC monitoring: IC(Internal Control) monitoring test process to avoid false negative results.

Parameters

Items	Parameter
Specimen Type	Throat swab
Extraction Platform	One-tube fast release technology Advanced magnetic beads technology
Anti-contamination system	UNG enzyme + dUTP system
PCR Instrument	ABI 7500; MA-6000; SLAN-96P; QuantStudio 5; iPonatic S-Q31A&B; S-Q36A
Sensitivity	200 copies/mL
Qualification	NMPA, CE

S3018E TB – Mycobacterium Tuberculosis DNA Fluorescence Diagnostic Kit

admin@sansure2021 — Wed, 01 Jun 2022 07:51:24 +0000

Brief

Mycobacterium tuberculosis virus (TB) is a pathogenic bacterium that causes tuberculosis. It is likely to infect all human tissues and organs, especially the lungs to cause pulmonary tuberculosis. Early diagnosis and treatment are important for effective control of tuberculosis. In recent years, with the development of molecular biology, nucleic acid fluorescence quantitative PCR method based on the mycobacterium tuberculosis nucleic acid has drawn more and more attention from researchers.

Parameters

Product features	Parameter
Specimen Type	Human sputum
Extraction Platform	One-tube fast release technology
Internal Control	Cloning plasmid, without TB target sequence
PCR Instrument	ABI 7500, SLAN-96P,MA-6000, Stratagene Mx3000P, iPonatic S-Q31A&B,S-Q36A
Sensitivity	1 bacterium/mL
Spec.	48T, 12-P
Qualification	CE

S3310E 6LRP – Six Respiratory Pathogens Multiplex Nucleic Acid Diagnostic Kit

xiaochen, liu — Fri, 27 May 2022 07:31:59 +0000

Brief

Lower respiratory infections (LRP) remained the world’s most deadly communicable disease, ranked as the 4th leading cause of death. In 2019 it claimed 2.6 million lives. Diseases of the lower respiratory tract include acute tracheitis, bronchitis, pneumonia, chronic bronchitis, chronic obstructive pulmonary disease, bronchiectasis, etc. They are caused by microbial infections such as viruses, bacteria, mycoplasma, chlamydia and legionella. Bacteria are the main pathogens of lower respiratory tract infections, with a wide variety of pathogens and complex clinical presentations. Due to the long detection period and low positive detection rate of traditional pathogenic tests, over 62% of adults with community-acquired pneumonia have no pathogenic basis. Failure to identify the cause quickly can delay treatment, exacerbate the disease and lead to death, and increase the development of antibiotic resistance.

Features

Highly efficient identification and rapid diagnosis: Six common bacteria of lower respiratory tract infections can be detected in one tube; a batch of 94 sample tests can finish in 100 minutes.
Accurate and reliable, high detection rate: sensitive and specific, unaffected by antibacterial drugs, full internal control monitoring to avoid false negatives, UDG enzyme + dUTP anti- contamination measures to reduce false positives.
Easy to operate and adaptable: automatic instruments are available, and the results can be intelligently analyzed by conventional fluorescent PCR instruments to meet the needs of medical laboratories , clinical Institutions, emergency and primary care etc.

Parameters

Items	Parameter
Specimen Type	Sputum
Extraction Platform	Advanced magnetic beads technology
Internal Control	Plasmid
PCR Instrument	Thermofisher QuantStudio™ 5 and SLAN-96P
Sensitivity	15 CFU/mL (Streptococcus pneumoniae) 340 CFU/mL (Legionella pneumophila) 625 CFU/mL (Haemophilus influenzae) 675 CFU/mL (Pseudomonas aeruginosa) 900 CFU/mL (Klebsiella pneumoniae) 2875 CFU/mL (Staphylococcus aureus)
Qualification	NMPA, CE

S3120E-H-SARS-CoV-2 Rapid Antigen Test for Self-testing

xiaochen, liu — Mon, 18 Apr 2022 04:35:42 +0000

Brief

The SARS-CoV-2 Rapid Antigen Test (Immunochromatography Assay) for self-testing is authorized for home use with self-collected nasal swab samples to directly detect antigen of SARS-CoV-2 virus. With the help of this kit, people without professional training can also easily acquire their COVID-19 test result within 15-20 minutes.

Features

Accurate Sensitivity 94.55%, Specificity 100%
Convenient No instrument needed, easy to operate
Fast Result available in only 15-20 min
Flexible Get tested anytime when you are free

Instruction

Result interpretation

Parameters

Qualification

Kit components

No.	Product Name	Spec.
S3120E-1-H, S3120E-5-H	SARS-CoV-2 Rapid Antigen Test (Immunochromatography Assay)	1 Test, 5 Tests

The kit components:

SARS-CoV-2-Antigen Test Cassette (with desiccant)
SARS-CoV-2 Sample Extraction Buffer
Swab
Plastic Waste Bag