When used with the Siemens urinalysis strips, CHEK-STIX® Positive and Negative Control Strips provide defined results for glucose, bilirubin, ketone, specific gravity, blood, pH, protein, urobilinogen, nitrite, and leukocytes. It is used to verify the integrity of results and provide a convenient basis for a urinalysis quality control program.
Each Chek-Stix Positive Control (Control +ve) Strip is a firm plastic strip to which are affixed seven separate analyte areas. These each contain one or more natural or synthetic ingredients that, when dissolved out of the analyte areas in a measured quantity of distilled or deionized water, produce a Positive Control Solution. Each Chek-Stix Negative Control (Control -ve) Strip contains six separate analyte areas. The ingredients are dissolved out of the analyte areas to produce a Negative Control Solution.
WHY IS A CONTROL STRIP NECESSARY?
Chek-Stix control solutions should be used on a regular basis as a part of Urinalysis Quality control program. Major areas of use are:
When used as a known positive or negative solution:
- To determine if Siemens urine strips are reacting properly.
- To confirm the user’s ability to properly perform and reliably interpret the reagent test strips.
- For demonstration and teaching.
When used as a blind or unknown solution:
- To develop proficiency in routine urinalysis performed in the laboratory from sample handling through test procedures to reporting of results.
- To provide confidence in obtaining good results in routine urinalysis.
RECONSTITUTION PROCEDURE
- Place 12 mL of distilled or deionized water in an appropriately labeled specimen tube. Do not use tap water.
- Remove a Chek-Stix Control Strip from the bottle and replace the cap immediately and tightly.
- Place the strip into the tube. Cap tightly.
- Repeat Steps 1–3 if using a second control.
- Gently invert the tube(s) back and forth for 2 minutes.
- Allow the tube(s) to stand for 30 minutes at room temperature.
- Invert one more time, then remove and discard the strip(s), according to your standard laboratory procedures.
After reconstitution, the Control Solutions should be treated and tested in the same manner as a urine specimen. Refer to the direction insert for the Siemens Reagent Strips or Tablets being used for complete information. Do not dip more than 12 Siemens Reagent Strips into a single tube of control solution, as expected values may change.
EXPIRY & STORAGE
This product has 18 months shelf life from the date of manufacture. Chek-Stix Control Strips to be stored in the original, tightly capped bottle at temperatures between 15–30°C. Do not store the bottle in direct sunlight.
The reconstituted solution is stable for 8 hours at 18–23°C (64–73°F), except for bilirubin in the Positive Control, which is stable for 3 hours. If your laboratory operates outside of this temperature range, Siemens recommends that the reconstituted solution be refrigerated at 2–8°C (34–46°F) to maintain the 8-hour stability.
PRODUCT ORIGIN
| Manufacturer | Siemens Healthcare Diagnostics Inc. |
| Importer | Siemens Healthcare Private Limited 9th Floor, North Tower Godrej One Pirojshanagar, Off Eastern Express Highway Vikhroli East, Mumbai 400079 India |
| Country of origin | USA |
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