Chlamydia Trachomatis Positive Control Microorganism (6 x 1.25 mL)
- Volume: 1.25mL
- Units/Pack: 6
- Storage Condition: 2-8°C
- Hazardous Information: Non-Infectious
- Matrix: Purified protein matrix treated with 0.09% sodium azide
- Product Type: Control
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Classification/ Permits:
IVD
Learn MoreXIn-Vitro Diagnostics.
CE
Learn MoreXEuropean Mark of Conformity.
Description
Old Part Number: MDZ002
ZeptoMetrix external controls have demonstrated performance on a variety of molecular assays. The product has been tested with the Cepheid® GeneXpert® or Hologic® Panther Fusion® system and provides the expected results, however performance characteristics must be established by the end user.
- Formulated with purified, intact organisms
- Organisms are chemically modified to render them noninfectious
- Refrigerator stable—store between 2 and 8°C
- Purified protein matrix treated with 0.09% sodium azide
- 6 x 1.25 mL vial
- CE IVD
Intended Use
NATtrol™ Chlamydia trachomatis (CT) Positive Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from this organism. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ Chlamydia trachomatis (CT) Positive Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures.
More Information
NATtrol™ CT Positive Controls are USA FDA Class 1 exempt, unassayed, in vitro diagnostic external run controls and are for professional use only. NATtrol™ CT Positive Controls are not intended for use as a substitute for the internal controls provided by in vitro diagnostic kit manufacturers. Quality control materials should be used in accordance with local, state, federal and accreditation requirements.