A useful QC plan does more than record that a control passed; it explains what the control protects and what happens when it fails. This guide uses the manufacturer IFU for catalogue 74156 as its technical anchor and translates it into practical review questions for professional laboratories.
Start with the product’s documented role
A.F. Genital System is a 24-well system containing desiccated biochemical and antibiotic substrates for detection, presumptive identification and susceptibility testing of microorganisms from urogenital specimens. The system also provides a semi-quantitative assessment of the presence of urogenital mycoplasmas, i.e. Mycoplasma hominis and Ureaplasma urealyticum. The system is inoculated with the suspension of the clinical sample and incubated at 36 ± 1°C. The test results are read after 24 hours of incubation and interpreted by assessing the change in color of the various wells and performing a microscopic examination. Note: The species Ureaplasma urealyticum has been divided into two new species: Ureaplasma parvum and Ureaplasma urealyticum. They are considered together as Ureaplasma spp.
Review Liofilchem A.F. GENITAL SYSTEM 74156 at Kormay Biomedicals
Design the workflow before opening the pack
Define the sample type, inoculum or preparation step, incubation conditions, control organisms, reading window, confirmation pathway, and acceptance criteria in the SOP. Record the catalogue number, lot, expiry, analyst, equipment, and any deviation that could change interpretation.
Preparation checkpoint
OF THE CLINICAL SAMPLE Carefully open a vial of Physiological Solution* using the ampule cracker provided with the kit. 1. VAGINAL SWAB – URETHRAL SWAB Immerse the swab (after obtaining the clinical material) in the vial of physiological solution and wait 5 minutes. Carefully squeeze the swab against the vial wall so that the clinical material is dispersed homogeneously in the Physiological Solution. Note: Keep the swab, dipped in a nutritive broth, until the conclusion of the test. 2.
Procedure points worth controlling
envisaged for the microbiological culture examination. The samples must be sent for inoculation in the A.F. Genital System immediately after they are taken. Do not store in the refrigerator for even limited periods of time, since low temperatures may damage the vitality of some particularly sensitive microorganisms (e.g. Trichomonas vaginalis, Neisseria gonorrhoeae etc.) and alter the final result. / 211 © Liofilchem - A.F. Genital System - Rev.8 / 03.08.2020
Read and document the result
OF THE RESULTS Count and Identification of mycoplasmas / ureaplasmas Watch for the color change in the wells 1-Uu 103 to 5-Mh ≥ 105 and interpret the results using Table 1. Detection of Trichomonas vaginalis and Candida spp. Take a drop of liquid from the well, deposit it on a glass slide, place a cover slip on top and examine at the microscope (40x) for the presence of T. vaginalis and Candida spp. Interpret as indicated in Table 1.
Quality control as a decision tool
Every batch of A.F. Genital System is subjected to
Storage and handling
OF THE SAMPLES Obtain the vaginal or urethral secretion with synthetic fibre swabs. Obtain the seminal fluid according to the
Safety and professional-use reminder
Neisseria gonorrhoeae, Streptococcus agalactiae and Gardnerella vaginalis require appropriate culture media, and additional biochemical and/or serological tests for complete identification. -Some bacteria that are present in quantities of ≥ 106-7 CFU/mL and produce urease, may cause all the wells in the panel to change colour. The presence of these can be verified by reisolating on agar medium (e.g. chocolate agar) from the original broth (see
A practical pre-release checklist
- Current IFU revision and catalogue code verified
- Receipt, storage, lot, and expiry documented
- Controls and acceptance criteria defined before testing
- Reading time and observations recorded without forcing an ambiguous endpoint
- Confirmation and deviation actions linked to the laboratory SOP
Final perspective
Useful technical content should help a laboratory make a better-controlled decision, not replace the IFU or validated method. Confirm the current manufacturer documentation and local regulatory requirements before implementation.