Aptima SARS-CoV-2 Assay, kit/250T

General description:
The Aptima SARS-CoV-2 assay is a nucleic acid amplification in vitro diagnostic test intended for qualitative detection of NRA from the SARS-CoV-2 virus isolated and purified from upper respiratory tract specimens obtained from individual who meet COVID-19 clinical and /or epidemiological criteria.

Technical specifications:
Principle: The Aptima SARS-CoV-2 assay combines the technologies of target capture, Transcription Mediated Amplification (TMA), and Dual Kinetic Assay (DKA).
Test format: RT- PCR Kit
By adding adequate collected specimen to the tube, there is enough volume to perform 2 nucleic acid extractions.
Deviations from the authorized extraction methods and authorized materials required to perform the Aptima SARS-CoV-2 assay are not permitted.
Kit size: 250 tests
Specimen type: Nasopharyngeal swabs, oropharyngeal swabs and sputum
By adding adequate collected specimen to the tube, there is enough volume to perform 2 nucleic acid extractions.
Deviations from the authorized extraction methods and authorized materials required to perform the Aptima SARS-CoV-2 assay are not permitted.
Time to result: 3.5 hours
Specimen volume: 500uL

Manufacturer product reference:
Hologic, Inc., PRD-06419

Items supplied with:
Aptima SARS-CoV-2 Refrigerated Box (Box 1 of 2)
- 1 Vial, (A) Aptima SARS-CoV-2 Amplification Reagent
- 1 Vial, (E) Aptima SARS-CoV-2 Enzyme Reagent
- 1 Vial, (P) Aptima SARS-CoV-2 Probe Reagent
- 1 Vial, (IC) Aptima SARS-CoV-2 Internal Control
Aptima SARS-CoV-2 Room Temperature Box (Box 2 of 2)
- 1 Vial, (AR) Aptima SARS-CoV-2 Amplification Reconstitution Solution (27.7 mL)
- 1 Vial, (ER) Aptima SARS-CoV-2 Enzyme Reconstitution Solution (11.1 mL)
- 1 Vial, (PR) Aptima SARS-CoV-2 Probe Reconstitution Solution (35.4 mL)
- 1 Vial, (S) Aptima SARS-CoV-2 Selection Reagent (108 mL)
- 1 Vial, (TCR) Aptima SARS-CoV-2 Target Capture Reagent (54 mL)
- 3, Reconstitution Collars
- 1 Sheet, Master Lot Barcode Sheet
Aptima SARS-CoV-2 Controls Kit (Cat. No. PRD-06420)
- 5 Vials, (PC) Aptima SARS-CoV-2 Positive Control (1.7 mL)
- 5 Vials, (NC) Aptima SARS-CoV-2 Negative Control (1.7 mL)
1 X IFU

Items required, but not supplied:
Instruments:
·Panther System - 303095
Other important items:
·Aptima Assay Fluids Kit - 303014 (1000 tests): Aptima Wash Solution, Aptima Buffer for Deactivation Fluid, and Aptima Oil Reagent.
·Aptima Auto Detect Kit - 303013 (1000 tests).
·Multi-tube units (MTUs) - 104772-02.
·Panther Waste Bag Kit – 902731.
·Panther Waste Bin Cover – 504405.
·Panther Run Kit - 303096 (5000 tests): contains MTUs, waste bags, waste bin covers, assay fluids, and auto detects. (#10772-02, #902731, #504405, #303014, #301013).
·1X960 case Tips, 1000 μL conductive, liquid sensing. (Cat. No. 10612513 (Tecan)
·Aptima Multitest Swab Specimen Collection Kit - PRD-03546.
·1 bag X 100 Hologic Specimen Lysis Tubes and Solide caps. #ASY-14723, #M995133. (PRD – 06554.
·1bag X 100 Specimen Lysis Tube. (Assy-14723).
·1 bag X 100 Universal Plug Yellow / Fischer Caps. (M995133)
·Replacement Caps for the 250-test kits:
-100 caps, Amplification and Prrequiredobe reagent reconstitution solutions - CL0041.
·100 caps, TCR and Selection reagent - CL0040.
- TCR and Selection reagent - CL0040 (100 caps).
·Hologic Bleach Enhancer for Cleaning – 302101.
General lab item:
·Bleach, 5% to 7% (0.7M to 1.0M) sodium hypochlorite solution.
·Disposable gloves.
·Replacement Caps for the 250-test kits.

Optional items:
·Hologic Bleach Enhancer for Cleaning - 302101
·Tube rocker

Shelf life:
12 months from the date of manufacture.

Weight & volume:
Estimated weight: 1.75 Kg
Estimated volume: 2.4685 dm³

Storage & transportation condition:
Aptima SARS-CoV-2 Refrigerated Box (Box 1 of 2)
Storage: 2 - 8°C
Shipping: Ambient
Aptima SARS-CoV-2 Room Temperature Box (Box 2 of 2)
Storage: 15 - 30°C
Shipping: Ambient
Aptima SARS-CoV-2 Controls Kit (Cat. No. PRD-06420)
Storage: 2 - 8°C
Shipping: Ambient

Packaging & labelling:
Primary packaging: All contents of Aptima SARS-CoV-2 Assay, kit of 250 tests
Secondary packaging: One Kit Aptima SARS-CoV-2 Assay, kit/250 tests