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The Control Set for the BD ProbeTec™ Herpes Simplex Viruses (HSV 1 & 2) Q^x Amplified DNA Assays contains Positive and Negative Controls that are intended for Quality Control use with the BD ProbeTec™ Herpes Simplex Viruses (HSV 1 & 2) Q^x Amplified DNA Assays (HSV Q^x Assays) when tested with the BD Viper™ System in Extracted Mode.

Quality control must be performed in accordance with applicable local, state and/or federal regulations or accreditation requirements and your laboratory's standard Quality Control procedures. It is recommended that the user refer to pertinent CLSI guidance and CLIA regulations for appropriate Quality Control practices.

The BD ProbeTec Herpes Simplex Viruses (HSV 1 & 2) Positive and Negative Controls must be included with each BD Viper run. Controls must be positioned according to the BD Viper Instrument User's Manual. The HSV Q^x Positive Control will monitor for substantial reagent failure only. The HSV Q^x Negative Control monitors for reagent and/or environmental contamination.

The HSV Q^x Positive Control contains cloned HSV1 and HSV2 target regions. These controls may be used for internal quality control or users may develop their own internal quality control material.¹ Additional controls may be tested according to guidelines or requirements of local, state, and/or federal regulations or accrediting organizations. Refer to CLSI C24-A3 for additional guidance on appropriate internal quality control testing practices.¹ The Positive Control contains approximately 15,000 copies per mL of pHSV1 and 16,500 copies per mL of pHSV2 linearized plasmids.

The HSV 1 & 2 Q^x Positive and Negative Controls (i.e., assay controls) do not require addition of fluid by the user prior to loading in the BD Viper Lysing Rack.

Interpretation of Quality Control Results

The HSV1 and HSV2 Positive Control and the HSV1 and HSV2 Negative Control must test as positive and negative, respectively, in order to obtain patient results. If controls do not perform as expected, the run is considered invalid and patient results will not be reported by the instrument. If either of the controls does not provide the expected results, repeat the entire run using a new set of controls, new extraction tubes, new extraction reagent trough, new lysis trough and new microwells. If the repeat QC does not provide the expected results, contact BD Technical Services.

Refer to the BD ProbeTec Herpes Simplex Viruses (HSV 1 & 2) Q^x Amplified DNA Assays package insert (Cat. No. 441749) for further interpretation of the quality control results.

Materials Provided:

Each Control Set for the BD ProbeTec Herpes Simplex Viruses (HSV 1 & 2) Q^x Amplified DNA Assays contains: 24 HSV Q^x Positive Control Tubes containing approximately 15,000 copies of pHSV1 and 16,500 copies of pHSV2 linearized plasmids in carrier nucleic acid, and 24 HSV Q^x Negative Control Tubes containing carrier nucleic acid alone. The concentrations of the pHSV1 and pHVS2 plasmids are determined by UV spectrophotometry.

Materials Required But Not Provided:

BD ProbeTec Herpes Simplex Viruses (HSV 1 & 2) Q^x Amplified DNA Assays and accessories, Nitrile gloves.

Storage and Handling Requirements: Reagents may be stored at 2 – 33°C. Do not freeze.

1. For in vitro Diagnostic Use.

2. The Control Set for the BD ProbeTec Herpes Simplex Viruses (HSV 1 & 2) Q^x Amplified DNA Assays is used to evaluate the performance of the BD ProbeTec Herpes Simplex Viruses (HSV 1 & 2) Q^x Amplified DNA Assays and should not be used with other methods.

3. For additional specific warnings, cautions, and notes specific to the BD Viper, consult the BD Viper Instrument User's Manual.

4. Because the HSV Q^x Positive Control is used for both HSV1 Q^x and HSV2 Q^x testing, correct positioning of the microwell strips is important for final results reporting.

5. Do not re-hydrate the controls prior to loading in the BD Viper Lysing Rack.

6. Do not eat, drink or smoke in areas where specimens or kit reagents are handled.