Each Directigen RSV ColorPAC device contains both internal positive and negative controls (i.e., two levels). The appearance of a purple control dot provides an internal positive reactivity control (level 1) that validates the immunological integrity of the device, proper reagent function, and assures that the correct test procedure was followed. The membrane area surrounding the triangle is the internal negative control (level 2) for the device. The lack of any color development in this background area indicates that the test has been performed correctly.

Liquid Positive (Control +) and Negative (Control –) controls are also supplied with each kit. These controls are provided as a means of additional quality control. At a minimum, the liquid controls should be run as a quality control procedure for each lot of each shipment received. The formation of a purple triangle on the membrane when the Control + is employed further indicates that the RSV antigen binding property of the membrane is functional. Do not use if the Control + and Control – do not give appropriate results.

The liquid controls may also be used to demonstrate a positive or negative reaction. As described under "Test Procedure" the Control + will demonstrate a strong positive reaction. Dilution (1:2 maximum) of the Control + with saline may be performed and tested to demonstrate a weaker positive reaction. Performance of reagents and technique may also be evaluated by using specimens known to be positive or negative.

Quality control requirements 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 (formerly NCCLS) guidance and CLIA regulations for appropriate Quality Control practices.

The Directigen RSV Test includes:

For in vitro Diagnostic Use.

Reagents: Do not use beyond the expiration date. Do NOT mix reagents from different kit lot numbers or mix reagent bottle caps.

To assure proper delivery, DispensTube devices and reagent bottles must be held vertically (approximately one inch from the ColorPAC membrane surface or tube), while gently dispensing one drop at a time, in quick succession.

The RSV Control + and control spot on the ColorPAC membrane have been prepared from RSV-infected tissue culture cells which have been inactivated and subsequently tested by bio-assay procedures.

Avoid contact of reagents with skin and mucous membranes. If reagents come into contact with these areas, flush with water and contact your physician.

Warning: Reagents contain sodium azide. Very toxic by inhalation, in contact with skin, and if swallowed. Contact with acids liberates very toxic gas. After contact with skin, wash immediately with plenty of water. Sodium azide may react with lead and copper plumbing to form highly explosive metal azides. On disposal, flush with a large volume of water to prevent azide build-up.

Swabs: For nasopharyngeal swabs (NPS), polyester or rayon-tipped swabs with an aluminum wire are recommended. Calcium alginate swabs are not recommended for use with the Directigen RSV Test.

Controls: Do not use the kit if the Control + and Control – do not yield appropriate results.

ColorPAC Device: Remove the device (with the inserted flow controller) from the foil pouch just prior to use.