SALIENT_CHARACTERISTICS_HPV_KIT.DOCX

SALIENT CHARACTERISTICS

General instrument characteristics include being able to run HPV, MRSA/SA, HSV 1/2, Cdiff, CT/NG, HCV, BRAF, KRAS, HBV, Factor II/V, EGFR v2 based assays on one RT-PCR technology based platform in batch sizes up to 96.

1. Characteristics:

A. Automated sample ID scanning.

B. Bar-coded data entry capabilities.

C. Bi-directional interface for host connection to connect to LIS.

D. Test-specific reagents.

E. Ready-to-use reagents, bar-coded cassettes.

F. All in one bench top instrument.

G. 120 Voltage.

H. Must be able to provide system installation and set-up.

I. Computer system (CPU, Monitor, Keyboard, Printer,), UPS for all instruments for the life of the instruments.

J. Must be able to provide complete system validation (or assist facility with validation, as needed).

K. Must be able to provide training for staff how to use and troubleshoot the system.

L. Operate within the existing environmental conditions of 15-35 °C and 15-75% relative humidity.

M. Accepts multiple primary and secondary vial formats.

N. Able to identify both low and high risk HPV at the same time.

O. Must be approved by the FDA for ASC-US triage, co-testing and first-line primary screening.

P. HPV testing with internal cellularity controls ensuring no false negatives if used as a primary screening method.

Q. Utilizing integrated HPV16/18 genotyping and cytology reflex of the 12 other high risk HPV genotypes, specific genotyping for HPV.

R. The HPV test must use amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of 14 high-risk (HR) HPV types in a single analysis.

S. The test specifically identifies (types) HPV 16 and HPV 18 while concurrently detecting the rest of the high-risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68) at clinically relevant infection levels.

T. Highly efficient signal excitation and data capture to reduce signal artifacts and ensure data integrity.

U. Pipette tip locking and monitoring technology, including CO-RE, TADM and anti-droplet control (ADC) for reliable sample transfer.

V. General instrument characteristics should include being able to run HPV DNA based assays on a RT-PCR technology based platform in flexible batch sizes of 24 or 96 for efficient reagent usage.

W. A proprietary Kinetic Algorithm ensures results are positive, negative, or invalid and growth curve analysis is unnecessary.

X. Capable of multiplexing up to 6 detections per amplified sample.

Y. An Internal Control/Quantitation Standard (IC/QS) incorporated into each individual sample and is carried through the sample preparation.

Z. Collaborating controls should be included as part testing from the same manufacturer.

AA. The systems must improve overall productivity in the Molecular Diagnostics Lab, reducing the need for repeat testing thus reducing reagent waste.

AB. The system should be able to accept the primary specimen container.

AC. The system should not require monitoring/user intervention during a run and should be 100% “walk-away” system.

AD. Overnight operation capabilities from start of specimen to finish.

AE. One test in one run, from one patient sample (1mL) eliminates the need for reflex testing and reduces the risk of QNS.

AF. Able to destroy previously generated PCR amplification to help significantly reduce the risk of false positive results. Eliminate the use of bleach solutions to prevent cross-contamination issues.

AG. Have Approval to Operate (ATO) on the DHA network and be bi-directionally interfaced with the Laboratory Informational System (Military Health System- Genesis).