Specifications for BioFire RP 2.1 IVD Test Kits.pdf

SPECIFICATIONS

Some additional useful specs:

The BioFire Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with the BioFire®FilmArray®2.0 or BioFire®FilmArray®Torch Systems for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infections, including COVID-19.

Sample type: NPS (nasopharangyla swab) Nucleic acids from the respiratory viral and bacterial organisms identified by this test are generally detectable in NPS (nasopharangyal) specimens during the acute phase of infection. (NOTE: This is NOT an antibody or antigen test).

Each kit contains sufficient reagents to test 30 samples (30-test kit – REF# 423742):

•Individually packaged BioFire RP2.1 pouches •Single-use (1.0 mL) Sample Buffer ampoules •Single-use pre-filled (1.5 mL) BioFire®FilmArray®Hydration Injection Vials (blue) •Single-use BioFire®FilmArray®Sample Injection Vials (red) •Individually packaged Transfer Pipettes

Reagent Storage, Handling and Stability:

• Store the test kit, including reagent pouches and buffers, at room temperature (15–25 ºC).• DO NOT

REFRIGERATE.

• Avoid storage of any materials near heating or cooling vents or in direct sunlight.

• All kit components should be stored and used together. Do not use components from one kit with those of another kit. Discard any extra components from the kit after all pouches have been consumed.

• Do not remove pouches from their packaging until a sample is ready to be tested. Once the pouch packaging has been opened, the pouch should be loaded as soon as possible (within approximately 30 minutes).

• Once a pouch has been loaded, the test run should be started as soon as possible (within approximately 60 minutes).

• Do not expose a loaded pouch to temperatures above 40°C (104°F) prior to testing.

SPECIMENS

The following describes the requirements for specimen collection, preparation, and handling that will help ensure accurate test results.

Specimen TypeNasopharyngeal Swab(NPS) collected according to standard technique and immediately placed in up to 3 mL of transport media or saline. Minimum sample volume: 0.3 mL (300 μL). Specimens should NOT be centrifuged before testing.

Transport and Storage Specimens should be tested with the BioFire RP2.1 as soon as possible.

If storage is required, specimens can be held:

•At room temperature for up to 4 hours (15-25 °C) •Refrigerated for up to 3 days (2-8 °C) •Frozen (≤-15 °C or ≤-70°C) (for up to 30 days)

DIMS for ONE pack of kits is as follows.

Dims

Item 30 Pack Length Width Height Cubic Feet Weight

30 Pack Kits 1 16 16 12 2 8

Additional Notes:

1. NATROL/Zeptometrix products and MMQCi or Maine Molecular QC products are for controls, not test kits.

2. Make sure these are the IVD version, and not the EUA version, as the IVD version replaced the EUA version. They had the same product name/title but a different part number.

3. Current kits shipping have an expiration date of March 15, 2023 or better.

4. Double check this is actually RP2.1, and not RP, RP2 or RP2plus, etc. RP, RP2, and RP2plus were discontinued in December.

The full target list is as follows:

Adenovirus Coronavirus 229E Coronavirus HKU1 Coronavirus NL63 Coronavirus OC43 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Human Metapneumovirus Human Rhinovirus/Enterovirus Influenza A, including subtypes H1, H3 and H1-2009 Influenza B Parainfluenza Virus 1 Parainfluenza Virus 2 Parainfluenza Virus 3 Parainfluenza Virus 4 Respiratory Syncytial Virus Bordetella parapertussis Bordetella pertussis Chlamydia pneumoniae Mycoplasma pneumoniae