Overview & Mechanism of Action
- Valfast Cassette Sperm Test ($1\text{-test}$ diagnostic cassette kit complete with sample transfer pipette, dilution buffer, and collection vessel) provides rapid visual screening of male reproductive health:
- SP-10 Protein / Cell Surface Antigen Identification: Utilizes high-affinity monoclonal antibodies in a lateral flow immunochromatographic cassette to bind acrosomal SP-10 protein unique to human spermatozoa, or employs specialized membrane colorimetric cell separation.
- WHO Cut-Off Threshold Calibration: Calibrated against World Health Organization ($\text{WHO}$) standard reference levels for normal semen parameters ($15\text{ million sperm/mL}$). A positive result indicates a sperm concentration at or above $15\times 10^6\text{ sperm/mL}$, while a negative result signals oligospermia ($<15\times 10^6\text{ sperm/mL}$).
- Rapid Diagnostic Clarity: Provides visual band results within 5 to 10 minutes, allowing discreet, preliminary evaluation of male reproductive capacity prior to comprehensive laboratory semen analysis.
Clinical Indications & Uses
- Valfast Cassette Sperm Test is indicated for:
- Preliminary, confidential screening of male fertility parameters in couples planning pregnancy
- Initial diagnostic assessment of suspected male-factor subfertility or oligospermia
- Secondary follow-up screening following medical lifestyle interventions or surgical varicocelectomy
Usage Guidance & Safety Precautions
Administration:
- Collect fresh semen into the provided clean vessel after a recommended abstinence period of 48 to 72 hours. Allow the semen sample to stand for 15 to 30 minutes until complete liquefaction occurs. Using the transfer pipette, mix the liquefied semen with the sample diluent, apply the specified drop volume into the cassette sample well ($S$), and read results at 5 to 10 minutes.
Recommended Dosage:
- Screening: Single-use test cassette. If an abnormal or negative result is obtained, repeat testing after 1 to 2 weeks or consult a fertility specialist for formal laboratory analysis.
Precautions & Warnings:
- For in vitro diagnostic screening use only. Not a substitute for a comprehensive laboratory spermogram (which evaluates total sperm count, motility, and morphology). Does not protect against sexually transmitted infections ($\text{STIs}$). Do not interpret test results past 15 minutes. Store between $2^\circ\text{C}$ and $30^\circ\text{C}$ in a dry environment away from direct heat, freezing, and moisture. Keep out of reach of children.