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Fluorecare COMBO 13in1 test | SARS-CoV-2 | Influenza A+B | RSV | Adenovirus | hMPV | Rhinovirus | PIV | Mycoplasma | Streptococcus | Legionella | Staphylococcus aureus | Klebsiella

149,99 PLN per piece

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Intended for professional use.

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Product description

Fluorecare COMBO 13in1 test (nasal swab/nasopharyngeal swab/throat swab)

 

This is a rapid test designed for the qualitative and differential detection of up to 13 pathogens simultaneously: antigens of SARS-CoV-2, Influenza A and B, RSV, Adenovirus, Human Metapneumovirus (hMPV), Rhinovirus, Parainfluenza Virus (PIV), as well as bacteria including Streptococcus pneumoniae (S.p.) – pneumococcus, Legionella pneumophila (L.p.), Staphylococcus aureus (S.a.) – golden staph, Klebsiella pneumoniae (Kpn) – pneumonia, and Mycoplasma pneumoniae (M.P.). The sample can be collected from the nasopharynx or throat of the patient.

1 swab = 13 results

The high sensitivity and specificity of this test ensure reliable and accurate results, available in just 12 minutes!

For professional use only.

This is a medical device. Use it in accordance with the instructions for use or the label.

Properties

  • sample material: nasopharyngeal swab or throat swab
  • painless sample collection
  • high-quality product
  • rapid results in just 12 minutes
  • single packaging
  • intended for professional use

Test specification

  • SARS-CoV-2: specificity: 100%, sensitivity: 92.93%, accuracy: 96.11%
  • Influenza A: specificity: 99.55%, sensitivity: 96.82%, accuracy: 98.40%
  • Influenza B: specificity: 100%, sensitivity: 97.47%, accuracy: 99.00%
  • RSV: specificity: 100%, sensitivity: 98.72%, accuracy: 99.40%
  • Adenovirus: specificity: 100%, sensitivity: 98.06%, accuracy: 99.00%
  • hMPV: specificity: 100%, sensitivity: 98.04%, accuracy: 99.00%
  • Rhinovirus: specificity: 98.68%, sensitivity: 97.48%, accuracy: 98.10%
  • PIV: specificity: 98.75%, sensitivity: 98.08%, accuracy: 98.40%
  • Mycoplasma pneumoniae: specificity: 95.89%, sensitivity: 93.57%, accuracy: 94.80%
  • Streptococcus pneumoniae: specificity: 99.19%, sensitivity: 95.00%, accuracy: 97.10%
  • Legionella pneumophila: specificity: 97.89%, sensitivity: 94.92%, accuracy: 96.50%
  • Staphylococcus aureus: specificity: 97.14%, sensitivity: 93.08%, accuracy: 95.20%
  • Klebsiella pneumoniae: specificity: 98.57%, sensitivity: 96.32%, accuracy: 97.50%

The package contains

  • 1 test cassette
  • 1 single-use sterile swab
  • 1 extraction buffer
  • user manual

Test application

  • This test is designed for the qualitative assessment of infections caused by SARS-CoV-2, Influenza A, Influenza B, RSV, Adenovirus, Human Metapneumovirus (hMPV), Rhinovirus, Parainfluenza Virus (PIV), and bacteria such as Streptococcus pneumoniae, Legionella pneumophila, Staphylococcus aureus, Klebsiella pneumoniae, and Mycoplasma pneumoniae. It enables the rapid detection or exclusion of the cause of a patient’s symptoms.
  • The test is especially recommended for general practitioners and pediatricians, as it allows for the simultaneous detection of 13 of the most common respiratory pathogens. Its painless sample collection method makes it suitable even for the youngest patients.

Product Identification Data and Responsible Entities

EAN Code: 6971348763046

Manufacturer Authorized Representative Importer / Distributor
Room 1001 of Unit 2, Room 1001 and Room 1101 of Unit 1, Building 2, Hongchuang Technology Center, Xikeng Community, Fucheng Sub-district, Longhua District,  518000 Shenzen China
bio@microprofit.com
+86 75529303416
www.microprofit-bio.com
CMC Medical Devices @ Drugs, S.L.
C/Horacio Lengo n18
C.P. 29006 Malaga Spain
info@cmcmedicaldevices.com
+34 951214054
www.cmcmedicaldevices.com
Bisaf Sp. z o.o.
Rdestowa 5 54-530 Wrocław Polska
24H@bisaf.pl
+48 503411527
www.bisaf.pl

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