Freeze-dried Six Respiratory Pathogens Nucleic Acid

Short Description:

This product is used for in vitro qualitative detecting nucleic acids of respiratory syncytial virus (RSV), adenovirus (Adv), human metapneumovirus (hMPV), rhinovirus (Rhv), parainfluenza virus type I/II/III (PIV I/II/III) and Mycoplasma pneumoniae (MP) in specimens of human oropharyngeal swab and nasopharyngeal swab from suspects of respiratory infection. The testing results will enable to assess the infection situation of RSV, Adv, hMPV, Rhv, PIV, MP in clinical practice as an aid in diagnosis of related virus infection in combination with epidemiology history, clinical manifestations and examination and other laboratory findings. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.


Product Detail

Product Tags

Product name

HWTS-RT177-Freeze-dried Six Respiratory Pathogens NucleicAcid Detection Kit (Fluorescence PCR)

Product Approval

IVDR

Epidemiology

Respiratory tract infection is the most common type of human disease, which can occur in any gender, age and region, and is one of the most important causes of morbidity and death in the world [1]. Clinically common respiratory pathogens include respiratory syncytial virus, adenovirus, human metapneumovirus, rhinovirus, parainfluenza virus (I/II/III) and mycoplasma pneumoniae, etc. [2,3]. The clinical symptoms and signs caused by respiratory tract infection are relatively similar, but the infection caused by different pathogens has different treatment methods, curative effects and course of disease [4,5]. At present, the main methods of laboratory detection of respiratory pathogens include virus isolation, antigen detection and nucleic acid detection, etc. This kit detects and identifies specific viral nucleic acids in individuals with signs and symptoms of respiratory infection, in conjunction with other clinical and laboratory results to assist in the diagnosis of respiratory infection. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.

Technical Parameters

Storage 2-28℃
Shelf-life 12 months
Specimen Type human oropharyngeal swab, nasopharyngeal swab
Ct ≤38
CV <5.0%
LoD 200 Copies/mL
Specificity Cross-reactivity: There is no cross-reactivity between the kit and Human boca virus, Cytomegalovirus, Herpes simplex virus type 1, Varicella zoster virus, Epstein-barr virus, Bacillus pertussis, Chlamydia pneumoniae, Corynebacterium, Escherichia coli, Haemophilus influenzae, Lactobacillus, Legionella pneumophila, Moraxella catarrhalis, Attenuated strains of mycobacterium tuberculosis, Neisseria meningitidis, Neisseria spp. (Neisseria gonorrhoeae), Pseudomonas aeruginosa, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, IFV A, IFV B, Parainfluenza IV, SARS-CoV-2, Coronavirus (HKU1), Coronavirus (OC43), Coronavirus (NL63).
Applicable Instruments Type I : Applied Biosystems 7500 Real-Time PCR Systems, SLAN-96P

Real-Time PCR Systems (Hongshi Medical Technology Co., Ltd.).

Type II test: EudemonTM AIO800 (HWTS-EQ007) by Jiangsu Macro &

Micro-Test Med-Tech Co., Ltd.

Work Flow

Type I: On conventional PCR system

3

Type II: On Eudemon TM AIO800

4

Reagents/Instrument need but not provided

Macro & Micro-Test Viral DNA/RNA Kit (HWTS-3017) (which can be used with Macro & MicroTest Automatic Nucleic Acid Extractor (HWTS-EQ011)) by Jiangsu Macro & Micro-Test MedTech Co., Ltd. and Macro & Micro-Test Viral DNA/RNA Kit (HWTS-3017-8) (used with EudemonTM AIO800) by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. Sample preservation solution: 0.9% sodium chloride solution, Virus Sampling Kit (MT0301-1) by Yocon Biology Technology Company (Beijing), UTM® Universal Transport Medium™ (GXB No.: 20191277) by Copan Italia S.p.A, Sample Collecting, Mailing & Shipping Kit (HWTS-3002) by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

Consumables need but not provided: DNase/RNase-free Tips, Disposable gloves, DNase/RNasefree EP tube, Magnetic bead extractor or magnetic rack.


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