TrueScience™ RespiFinder® Pathogen & Viral Identification Panels for Sanger Sequencing

Detect Multiple Pathogens—One Tube, One Patient Sample

Broad spectrum—detect presence of up to 15 viral and 4 bacterial pathogens with one panel
Rapid test—diagnostic result available typically within 8 hours of nucleic acid isolation
Clarity of results—differentiate up to 19 different pathogens, with a single patient report
Minimal hands-on time—multiplex assay may reduce pipetting and sample transfer steps
CE-IVD marked*—supports the demanding needs of process-controlled environments

TrueScience™ RespiFinder® 15 Viral Panel

TrueScience™ RespiFinder® 19 Pathogen Panel

* CE-IVD label applies to the kit only, secondary interpretation software is not part of the claim.

The TrueScience™ RespiFinder® Pathogen and Viral Identification Panels meet the requirements of the In Vitro Diagnostic Medical Device Directive.

Pathogens Detected

Respiratory Pathogens	TrueScience™ RespiFinder^® 15	TrueScience™ RespiFinder^® 19
Influenza A	X	X
Influenza B	X	X
Influenza A H5N1 **	X	X
RSV A	X	X
RSV B	X	X
Adenovirus	X	X
Rhinovirus	X	X
Coronavirus 229E	X	X
Coronavirus NL63	X	X
Coronavirus OC43	X	X
Parainfluenza 1	X	X
Parainfluenza 2	X	X
Parainfluenza 3	X	X
Parainfluenza 4	X	X
Human Metapneumovirus	X	X
Bordetella pertussis		X
Chlamydophila pneumoniae		X
Mycoplasma pneumoniae		X
Legionella pneumophila		X

** Influenza A H1N1v infections will (also) show a positive result for Influenza A.

FAQs

Are the TrueScience™ RespiFinder^® panels available in my country?

TrueScience™ RespiFinder^® panels are not available for sale in United States of America. The panels are available for sale in: UK, Germany, Switzerland, Austria, Norway, Sweden, Finland, Denmark, Estonia, Latvia, Lithuania, Bulgaria, Ireland, Spain, Portugal, Poland, Czech R., Hungary, Greece, Luxemburg, Slovakia, Slovenia, Romania, Croatia, Serbia, Turkey, Israel, South Africa, India, Colombia, Singapore, Morocco, Kenya, Nambia, Tanzania, Zambia, China (RUO), Hong Kong, Taiwan (RUO), Thailand (RUO), Korea (RUO), Indonesia, Malaysia.

The panels are available from distributors in France, Italy, Belgium, and the Netherlands. Please contact info@pathofinder.com for distributor information.

What types of samples can I test with the TrueScience™ RespiFinder^® Pathogen Identification Panels?

Recommended starting material is purified total nucleic acid (RNA and DNA) extracted from nasopharyngeal swabs and aspirates, sputum or bronchealveolar lavage.

Can I run samples analyzed with the RespiFinder^® panels on my Applied Biosystems Genetic Analyzer?

The TrueScience RespiFinder panels are optimized and supported for use with the 3130 Series and 3500 Series Genetic Analyzers. Although not officially supported by Life Technologies, our customers have demonstrated satisfactory performance of the panels when run on the 310 or 3100 and 3730 Genetic Analyzers.

How long does it take to complete the full workflow?

Diagnostic results are typically available within 8 hours of nucleic acid isolation requiring less than 2 hours of operator hands-on time.

What nucleic acid isolation methods does Applied Biosystems recommend for use with the RespiFinder Panels?

Several manual and automated nucleic acid preparation protocols and kits have been demonstrated to yield satisfactory results; a list of recommended products is published in the protocol.

What components are included in the TrueScience™ RespiFinder^® Panels?

All components needed to perform the assay are provided, including essential enzymes. Please view the list of components in the table below.

AB PN	AB Name	Description
4460381	TrueScience™ RespiFinder^® 15 Viral Identification Panel	Detects and Identifies 15 Respiratory Viruses 50 Tests
4460382	TrueScience™ RespiFinder^®19 Pathogen Identification Panel	Detects and Identifies 15 Respiratory Viruses + 4 Bacteria 50 Tests

5✕ RT-PCR Buffer

dNTP Mix

RT-PCR Enzyme Mix

Internal Amplification Control (IAC)

Pre-Amplification Primer Mix

Hybridization Buffer

Probe Mix

TwoStep Buffer

Ligase Enzyme

Taq Polymerase

Dilution Buffer

Reference Marker (FAM™)‡

Literature

Intended Use Statement

The TrueScience™ RespiFinder® 19 Pathogen Identification Panel and TrueScience™ RespiFinder® 15 Viral Identification Panel are qualitative multiparameter tests intended to simultaneously detect and identify common respiratory pathogens from purified total nucleic acids.

The input sample is total nucleic acids extracted and purified from nasopharyngeal swabs, nasal aspirates, sputum, and bronchoalveolar lavages (BAL) from patients suspected of respiratory tract infections. Preparation of clinical samples is a separate process from the scope of the panels; use suitable methods or products to handle specimens and extract and purify nucleic acids.

The TrueScience™ RespiFinder® Identification Panels aid in the diagnosis of respiratory tract infection when used in conjunction with other clinical and laboratory findings. Negative results do not necessarily indicate absence of viral or bacterial respiratory tract infection; negative results should not be used as the sole basis for diagnosis, therapy, or other treatment decisions. Positive results do not exclude co–infection with other pathogens. The pathogen(s) detected may not be the definite cause of disease. Other laboratory testing and assessment of clinical presentation must be included in the final diagnosis. Performance characteristics were established with validated EQA panels from www.qcmd.org. The product is for use by laboratory professionals, and it is intended for use with certain instruments and data analysis software from Applied Biosystems.

Pathogens Detected