MMQCI Xpert FII & FV Genotype Panel G109

Order Number: G109

Kit contains: 4 x 0.5mL bottles

(2 Heterozygous, 1 Normal & 1 Mutant)

Xpert FII & FV Genotype Panel G109 DataSheet

INTENDED USE:

XPERT FII & FV GENOTYPE PANEL G109

INSTRUCTIONS FOR USE:

Xpert FII & FV Genotype Panel G109 is intended for in vitro use as a quality control to monitor analytical performance of FII & FV detection on the GeneXpert^® System. Xpert FII & FV Genotype Panel G109 is formulated to monitor the detection of mutations Factor II G20210A and Factor V Leiden G1691A, the most common genetic risk factors for thrombotic events.

Xpert FII & FV Genotype Panel G109 is provided for Research Use Only (RUO). It cannot be cloned, sold, or transferred without the explicit written consent of MMQCI.

PRODUCT SUMMARY and PRINCIPLE:

Xpert FII & FV Genotype Panel G109 consists of a suspension of synthetic Factor II and Factor V DNA in a proprietary matrix with preservatives. All genotypes are represented in the four-bottle kit. Two bottles of Xpert FII & FV Heterozygous Control contain heterozygous DNA for both Factor II and Factor V. One bottle of Xpert FII & FV Normal Control contains wild type Factor II and Factor V DNA. One bottle of Xpert FII & FV Mutant Control contains homozygous mutant Factor II and Factor V DNA.

Best practice is to establish a quality control program for every assay performed by the laboratory.^{1, 2} Routine use of quality controls that are consistent lot to lot and monitor the entire assay assists the laboratory in identifying shifts, trends, and increased frequency of random errors caused by variations in the test system, such as failing reagents. Early investigation can prevent failed assay runs.

COMPOSITION:

Xpert FII & FV Genotype Panel G109 is comprised of four bottles containing 0.5mL each of synthetic Factor II and Factor V DNA suspended in a non-infectious matrix with carrier DNA, preservatives and stabilizers.

Specific mutations present are described below.

STORAGE AND STABILITY:

Upon receipt and after opening, the material should be stored at 2° – 8°C.  Do not freeze.

Unopened Xpert FII & FV Genotype Panel G109 material is stable through the expiration date printed on each bottle when stored refrigerated (2° – 8°C).

Opened material tightly capped and returned to the refrigerator (2° – 8°C) shortly after use is stable for thirty

(30) days from the date of opening.

Process Xpert FII & FV Genotype Panel G109 as you would a whole blood specimen:

1. Allow Xpert FII & FV Genotype Panel G109 to come to room temperature (18° – 25°C).
2. Thoroughly mix the solution prior to opening by inverting the bottle several times or placing on an automated mixer immediately before
3. Follow manufacturer’s test instructions for clinical
4. Tightly recap each bottle after use and store refrigerated (2° - 8°C).
5. Controls should be tested routinely as a matter of Good Laboratory Practice (GLP) and according to guidelines or requirements of local, state, and/or federal regulations or accrediting

PRECAUTIONS AND WARNINGS:

Xpert FII & FV Genotype Panel G109 is for use on the GeneXpert^® System only. Please contact MMQCI for controls to be used for other test systems that detect mutations Factor II G20210A and Factor V Leiden G1691A.

This product contains 23% ethanol (v/v) and could be flammable. Keep away from open flames.

This product is intended for in vitro analytical testing and is provided for Research Use Only, not for use in diagnostic procedures. This product does not contain any biological material of human origin and is non-infectious.

EXPECTED VALUES:

Other Factor II and Factor V mutations are not detected in the Xpert FII & FV Genotype Panel G109.

The laboratory should follow Good Laboratory Practice (GLP) and establish its own performance characteristics for the Xpert FII & FV Genotype Panel G109 in demonstrating adequate system performance.

ORDERING INFORMATION:

Xpert FII & FV Genotype Panel G109

Order Number: G109

Kit contains:        4 x 0.5mL bottles

(2 Heterozygous, 1 Normal & 1 Mutant)

1. ISO 15189: Medical laboratories – Particular requirements for quality and
2. CAP Molecular Pathology Checklist; Commission on Laboratory Accreditation, Laboratory Accreditation Program, 20000