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Group A Streptococcus (GAS), also known as Streptococcus pyogens, is a common Gram-positive pathogen, which is the main pathogen causing acute tonsillitis, pharyngitis and scarlet fever in children. Some strains can cause serious complications such as rheumatic fever/rheumatic valvular heart disease and acute glomerulonephritis. GAS is one of the pathogens that can cause the most kinds of human diseases so far, and it is also one of the most common respiratory pathogens. It is easily confused with pharyngitis caused by mycoplasma pneumoniae and respiratory viruses in clinical practice. Accurate diagnosis of the causative agent is an important condition for correct treatment of the disease.

Bioer has developed a novel Real-Time PCR kit for the detection and identification of Group A Streptococcus. In addition, the kit also adds human internal control, monitoring the whole process of specimen collection, transportation, nucleic acid extraction, PCR amplification, to ensure the effectiveness of the whole process.

Product features

1, Fast detection speed: Results can be obtained in about 1 hour.

2, Simple operation: One-step PCR is used to avoid aerosol contamination.

3, High sensitivity: Tested with three different batches of reagents, the detection sensitivity can reach 500 copies/mL.

4, Strong specificity: There is no cross-reaction with a variety of common respiratory pathogens such as Escherichia coli, Group B Streptococcus, Group C Streptococcus, Group G Streptococcus, Haemophilus influenzae, Streptococcus pneumoniae, Neisseria meningitidis, Staphylococcus epidermidis, Capnocytophaga canimorsus, Klebsiella pneumoniae, E. coli, Bordetella pertussis, Catarrhalis, Aspergillus flavus, Streptococcus oralis, Group A Streptococcus, Parainfluenza virus, Enterovirus, Rhinovirus, Measles virus, Bocavirus, Influenza A virus, Influenza B virus, Respiratory syncytial virus, Adenovirus, Staphylococcus aureus, and Mycoplasma pneumoniae.

5, Strong anti-interference ability: Potential interfering substances such as blood (10%), mucin (0.2mg/mL), hydroxymethyluracil (0.05mg/mL), sodium chloride (0.09%), betamethasone (0.05mg/mL), dexamethasone (0.1mg/L), flunisolide (0.1mg/mL), triamcinolone (105ng/mL), budesonide (3nmol/L), mometasone (0.2mg/mL), fluticasone (0.5ng/mL), histamine hydrochloride (1mg/mL), zanamivir (142ng/mL), ribavirin (3.6μg/mL), oseltamivir (0.02mg/mL), and paramivir (10μg/mL) have no effect on the detection results.

6, High precision: The CV values of the high and low concentration precision reference materials are both ≤5%.

7, High accuracy: The positive coincidence rate of the reference material is 100%, and the negative coincidence rate is 100%.

8,Certificate: CE-IVD

Product parameters
Experimental data

Accuracy: Hangzhou Bioer Technology Co., Ltd. positive reference samples P1-P9 and negative reference samples N1-N10 were extracted by using Bioer extraction reagent BSC86S1E (Zhejiang Medical Device Approval No. 20200872) as required, and then tested.

Result: The results showed that the test could accurately detect Group A Streptococcus, with a positive coincidence rate of 100% and a negative coincidence rate of 100%.

Linear relationship: A strain of Group A Streptococcus was diluted by a 10-fold gradient. Use Bioer BSC86S1E extraction reagent to do the extraction and then detect the samples.

Result: The results showed that after the A streptococcus strains were diluted by 10-fold gradient, the amplification correlation coefficient was above 0.995, indicating a good linear relationship.

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