Chemdye PRO1 MICRO Hygiene Monitoring System

Product Description

The Chemdye® PRO1 MICRO Hygiene Monitoring System is designed to detect and quantify residual proteins and iatrogenic agents on medical instrument surfaces after the cleaning process. It is crucial for verifying the efficiency of cleaning, reducing the risk of prion disease transmission, and predicting the effectiveness of further disinfection and sterilization processes. The system uses a high-absorption swab for efficient sample collection from various surfaces. A visual color change indicates the presence of detectable protein levels, with a quantification range from 1 to 50 μg of protein and a limit of detection (LOD) of 0.5 μg* in just 4 minutes.

Chemdye® PRO1 MICRO, along with Bionova® Auto-readers, provides the necessary equipment for Residual Protein Testing as described in HTM 01-01 and HTM 01-05 UK guidelines, APSIC guideline, and ISO 15883-1, 15883-5 Standards.

Indications for Use

Use for testing any surface after the cleaning process and for hard-to-reach areas in complex instruments, such as serrated edges or box joints.

Precautions

• Do not open until use.
• Do not reuse.
• Do not touch the swab or the inside of the device with your hands.
• Wear gloves, surgical mask, and other hygiene measures.
• Do not freeze.
• High concentrations of alkaline detergents may cause false negative results in some cases.
• Hydrogen peroxide-based disinfectants may cause a false positive color change reaction.
• Although Chemdye® PRO1 MICRO has high sensitivity, it is not a microbiological monitoring device, and surfaces should not be considered sterile based on the results obtained.

Instructions for Use

1. Remove the device from the pouch and allow it to reach a temperature of 20-25 °C.
2. Remove the swab from the device (Fig. A). Carefully apply 2 drops of moisturizer on the swab tip.
3. Swab thoroughly the surface to be tested (Fig. B). Swab in a zigzag pattern in one direction, then repeat perpendicularly (Fig. B). Press and rotate the swab several times while collecting the sample. Standardize the surface for sampling for comparable hygiene tests, preferably from the same surface region, especially in hard-to-reach areas.
4. Place the swab back into the device (Fig. C).
5. Activate it by pressing firmly downwards (Fig. D).
6. Shake vigorously downwards until the solution turns green and reaches the reference volume of the readout cone (Fig. E).
7. Shake vigorously downwards for 15 seconds, with the swab submerged in the solution (Fig. F). WARNING: Once activated, incubate the pen immediately for final readout.
8. Slide the swab upwards without removing it from the device (Fig. G).
9. Shake vigorously downwards and collect the solution until reaching the volume level indicated in the reference readout cone (Fig. H and I). CAUTION: If the device is not shaken properly or if there is a great presence of bubbles, the results can be invalid.
10. Make sure that the swab is outside the readout cone (Fig. I).
11. Incubate the Chemdye® PRO1 MICRO device at 60 ± 2 °C (Fig. J) for:
    • 4 minutes in a Bionova® MiniPro incubator.
    • 7 minutes in Bionova® IC10/20, IC10/20FR, IC10/20FRLCD incubators.
    IMPORTANT: Incubation must be done without the swab submerged in the solution and immediately after the activation stage.
12. For quantitative analysis, use Bionova® Auto-reader incubators (IC10/20FR, IC10/20FRLCD, or MiniPro). Read the instructions for use before using these devices.
13. For semi-quantitative analysis, remove the Chemdye® PRO1 MICRO immediately after the incubation time and interpret visually using the reference color guide. IMPORTANT: Estimations should be done within 5 minutes after removing the device from the incubator. Results analyzed beyond this period are not valid.
14. After using the Chemdye® PRO1 MICRO System, reprocess the instrument or surface used for protein monitoring.
15. IMPORTANT: During activation, the swab tip could detach. If this happens, repeat the test with a new pen. If the swab tip is retained in the reading cone, a visual estimation can be carried out after incubation at 60 °C as detailed in section 12.
16. NOTE: If any serious incident occurs, report it to Terragene S.A. and the competent authority.

Storage

Store Chemdye® PRO1 MICRO System at temperatures between 2-30 °C, away from light and with relative humidity (RH) of 30-80 %. Store vertically as indicated on the packaging. Shelf life is 24 months when refrigerated (2-8 °C) or a maximum of 6 months at room temperature (up to 30 °C). 1 month of storage at room temperature reduces the expiration date by 4 months.

Disposal

Discard the product after use according to your country’s healthcare and safety regulations.

References

• Bonda DJ, Manjila S, Mehndiratta P, et al. Human prion diseases: surgical lessons learned from iatrogenic prion transmission. Neurosurg. Focus. 2016;41(1):E10.
• Hervé RC, Hedges J, Keevil CW. Improved surveillance of surgical instruments reprocessing following the variant Creutzfeldt-Jakob disease crisis in England: findings from a three-year survey. J. Hosp. Infect. 2021;110:15-25.
• Alfa MJ, DeGagne P, Olson N, Hizon R. Comparison of liquid chemical sterilization with peracetic acid and ethylene oxide sterilization for long narrow lumens. Am. J. Infect. Control. 1998;26(5):469-77.

Symbols Explanation

• CE mark: Conformity to European standards.
• Authorized representative in the European Community.
• Batch number: LOT
• Manufacture Date.
• Expiration Date.
• Medical Device: MD
• Manufacturer: Terragene S.A.

Contact Information

Terragene S.A.
Ruta Nacional Nº 9, Km 280-CP 2130.
Parque Industrial Micropi- Alvear-Santa Fe-Argentina.