Gentaur distributes the Fosun COVID-19 RT-PCR Detection Kit

CE approved and use under the Emergency Use Authorization (EUA) only by the FDA

FDA Emergency Use Authorization (EUA) Only
Rx Only

NatTrol Covid qPCR Run Controls for certification of your IVD protocol

Fosun RT-PCR Covid PCR kit needs to be used with the following run controls:

SARS-Related Coronavirus 2 (SARS-CoV-2) External Run Control (6 x 0.5 mL)

NATSARS(COV2)-ERC

SARS-Related Coronavirus 2 (SARS-CoV-2) Negative Control (6 x 0.5 mL)

NATSARS(COV2)-NEG

SARS-Related Coronavirus 2 (SARS-CoV-2) Stock

NATSARS(COV2)-ST

SARS-Related Coronavirus 2 (SARS-CoV-2) Negative Control (6 x 1.0 mL)

NATSARS(COV2)-NEG1

SARS-Related Coronavirus 2 (SARS-CoV-2) External Run Control (6 x 1.0 mL)

NATSARS(COV2)-ERC1

For In Vitro Diagnostic Use.

Covid-19 RT-PCR Detection Kit Targeting Three Genes

The Fosun COVID-19 RT-PCR Detection Kit is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in upper and lower respiratory specimens (such as anterior nasal swabs, mid-turbinate nasal swabs, nasopharyngeal swabs, oropharyngeal swabs, sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal aspirate) from individuals suspected of COVID-19 by their healthcare provider. The kit detects ORF1ab, N and the E genes of the SARS-CoV-2 virus. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C. §263a, to perform high complexity tests CLIA waived.

About FDA Emergency Use Authorization (EUA)

Products

Product Name	Catalog Number	Package Quantity
Fosun COVID-19 RT-PCR Detection Kit	PCSYHF03-a	96 Tests/Kit

Components

1. SARS-COV-2 Reaction Reagent
2. RT-PCR Enzyme
3. Positive Control of SARS-CoV-2
4. Negative Control
5. Internal Reference A

Resources

1. Healthcare Provider Fact Sheet (HCP)
2. Patient Fact Sheet (Patient)
3. Instructions for Use (IFU)
4. Symbols Glossary

1. Limit of Detection | 300 copies/mL
2. Instrument | Applied Biosystems 7500
3. Storage & Shelf Life | -25° C to -15° C with protection from light, 12 months

Features

1. 3 Targets | ORF1ab, N and E genes
2. Sample Types* | Including Nasopharyngeal swab, Oropharyngeal swab, Sputum
3. Amplification Time | 1 hour 20 minutes
4. Controls | Internal control, UNG enzyme and dUTP used to reduce risk of contamination, false positive and false negative results

*Upper and lower respiratory specimens such as anterior nasal swabs, mid-turbinate nasal swabs, nasopharyngeal swabs, oropharyngeal swabs, sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal aspirate. 

Lieven Gevaert, Bio-ir RUG 1996

Features

1. Sterilized by ethylene oxide
2. Nylon Flocking tip
3. Acrylonitrile Butadiene Styrene (ABS) plastic shaft
4. 80mm Breakpoint
5. 3 year Shelf Life

Resources

• Fosun Nasopharyngeal Swab-Instructions for Use (IFU)

1. Intended Use | Used for collecting nasopharyngeal specimens, only for in vitro analysis and detection purposes, not for therapeutic use.
2. Transportation | In the process of transportation, protect against heavy load, direct sunlight, rain and snow.
3. Storage & Shelf Life | Store in a clean, cool and dry environment with good ventilation. Avoid corrosive gas, high temperature and high humidity (more than 80% relative humidity). 3 years from date of manufacture

Product Name	Catalog Number	Package Quantity
Oropharyngeal Swab	FS2001	100 Packs/Carton (1 per pack)

Features

• Sterilized by ethylene oxide
• Nylon Flocking tip
• Acrylonitrile Butadiene Styrene (ABS) plastic shaft
• 30mm Breakpoint
• 3 year Shelf Life

Resources

• Fosun Oropharyngeal Swab-Instructions for Use (IFU)

1. Intended Use | Used for collecting oropharyngcal specimens, only for in vitro analysis and detection purposes, not for therapeutic use.
2. Transportation | In the process of transportation, protect against heavy load, direct sunlight, rain and snow.
3. Storage & Shelf Life | Store in a clean, cool and dry environment with good ventilation. Avoid corrosive gas, high temperature and high humidity (more than 80% relative humidity). 3 years from date of manufacture

Product Name	Catalog Number	Package Quantity
Fosun Phosphate Buffered Saline	PCSYWE-a	100 Tubes/Carton

Features

SIZE: 3 mL in 18 x 101 mm Tube

INGREDIENT: Na₂HPO₄·12H₂O, KH₂PO₄, NaCl and Water

LIMITATIONS: For In Vitro Diagnostic Use. For transport of specimens only. Not to be taken internally.

Resources

• Fosun Phosphate Buffered Saline – Instructions for Use (IFU)

1. Intended Use | Single-Use Device. For transport of clinical material and serves as a culture media, non-selective and non-differential.
2. Storage & Shelf Life | Stable for 12 months while stored at 2°C – 30°C (36°F – 86°F). Store and transport upright at 2°C – 30°C (36°F – 86°F). Please see carton and tube label for expiration date.

Product Name	Catalog Number	Package Quantity
Nucleic Acid Extraction Reagent	2001FC	96 Preps/Kit

Features

MODEL: MNP-96C

COMPONENTS: MNP Lysis-binding Buffer, MNP Magnetic Beads, MNP Washing Buffer I, MNP Washing Buffer II, MNP Elution Buffer

LIMITATIONS: Plates provided in this kit are single-use only. Do not reuse the plates. For In Vitro Diagnostic Use. 

Resources

• MNP Elution Buffer – Instructions for Use (IFU)

1. Intended Use | This kit with reagents for 96 isolations was designed for the isolation DNA/RNA from upper respiratory tract specimens (including oral swabs, throat swabs, nasal swabs and nasopharyngeal extracts), lower respiratory tract specimens (including bronchoalveolar lavage fluid and alveolar lavage fluid). For Professional Use Only
2. Storage & Shelf Life | Stable for 6 months from date of manufacture while stored at room temperature 10°C – 30°C (50°F – 86°F). Please see label for date of manufacture.