Lifesign 200014 - StatusFirst Mono Controls, 2 x 1 mL
StatusFirst Mono Controls, 2 x 1 mL
StatusFirst Mono Control Positive Control is intended for use as unassayed precision control material for in vitro serological tests that detect antibodies to Infectious Mononucleosis (IM). The use of these controls enable the laboratorian to monitor changes in calibration, along with any analytical error and imprecision. These are not intended to replace any controls furnished with a commercial kit. They are not intended for use as a standard.
- CLIA WAIVED for whole blood
- FDA cleared with no age restrictions
- Single reagent procedure provides results in 3-8 minutes
- Fingerstick whole blood convenience
- Superior 99.9% sensitivity for earlier IM detection, specificity of 98.8%
- Multiple kit sizes available, ideal for any practice
- New plastic sample transfer pipettes
StatusFirst Mono Controls Summary And Principle
Emphasis for many years on quality control procedures in serology has resulted in a high uniformity of test performance within and among laboratories. One of the most important quality control procedures for assurance of reliable and reproducible tests results is the use of stable control serum samples that have a predetermined reactivity potency and pattern. Routine use of controls enables laboratories to monitor day-to-day testing, operator and lot-to-lot performance of test kits variation, as well as identifying systematic errors.
StatusFirst Mono Control Positive Control is developed for use as control material to monitor intra-laboratory system performance and estimate precision. These controls may also be used to control reactivity readings from day to day depending on the test system employed. Each lot of StatusFirst Mono Control Positive Control is tested in several different methodologies and assay systems to insure proper reactivity. Whenever possible, the controls are tested and compared with WHO, CDC or industrial standards.
ReagentsStatusFirst Mono Controls
StatusFirst Mono Control Positive Control (0.5 ml) is liquid and ready to use. WARNING: Contains Human serum with 0.1% Sodium azide. For in vitro diagnostic use only. Contents sterile until opened.
StatusFirst Mono Control Negative Control (0.5 ml) is liquid and ready to use. WARNING: Contains Human serum with 0.1% Sodium azide. For in vitro diagnostic use only. Contents sterile until opened.
Test Procedure ofStatusFirst Mono Controls
Remove the cap. Dispense 1 drop (20-25 ul) of control into the sample well and follow procedure as indicated in package insert.
Procedural Precautionsof StatusFirst Mono Controls
- Pipette and dispense reagents and specimens accurately since this will affect the quantitative results.
- Follow the directions for use of the IM test being employed.
- Discard if gross contamination or turbidity is observed.
Preparation For Use
StatusFirst Mono Control Positive and Negative Controls are ready to use. Allow materials to equilibrate to room temperature and invert gently to mix prior to use.
Procedure Use Status
First Mono Control Positive and Negative Controls in the same manner as patient samples according to the direction of the test kit being employed. Use any recognized method such as those described in the package insert of the product being used or the statistical rules described in NCCLS C24-A for assessing assay precision and to establish a target value and control limits. Other useful references include The Manual of Clinical Microbiology (5) and The Manual of Clinical Immunology (6).
Performance Characteristics And Expected Values
The StatusFirst Mono Control Positive Control should test positive unless it has been diluted beyond the sensitivity of the test being employed. For interpretation of endpoint / results refer to the "PERFORMANCE CHARACTERISTICS" of the kit being employed. The StatusFirst Mono Control Negative Control should test negative. Each laboratory must establish complete quality control testing in accordance with the requirements of regulatory and/or accrediting organizations and the laboratorys quality control goals. A trend log should be maintained for batch to batch consistency of the test. Large variations from the established mean may result from manufacturers modifications to the test system or improper technique.
