Table 1.
Overview of donor screening tests.
| Test | Acceptable range | Timing |
|---|---|---|
| Vaginal pH | < 4.8 | Screening |
| Wet mount | No yeast, trichomonas | Screening |
| Vaginal Gram stain | Nugent < 3 | Screening |
| Urine pregnancy test | Negative | Screening |
| Complete blood count |
WBC: 4.5–11 K/μL Hematocrit: 30–46% Hemoglobin: 12–16 g/dL Platelets: 100–400 K/μL |
Screening |
| Basic metabolic panel | Values < 1.2 × upper limit of normal* | Screening |
| Liver function tests | Values < 1.2 × upper limit of normal* | Screening |
| Hemoglobin A1C | 4.3–6.4% | Screening |
| Pap smear | No abnormalities | Screening |
| Human papillomavirus DNA | Negative for high-risk types |
Screening Each donation |
| Urine culture | Negative | Screening |
| Urine toxicology screen | Negative | Screening |
| Semen (PSA card) | Negative | Each donation |
| Nucleic acid amplification tests for Neisseria gonorrhoeae, Chlamydia trachomatis, Trichomonas vaginalis, Mycoplasma genitalium | Negative |
Screening Final donation |
| Treponemal test for syphilis (Trep-Sure) | Negative | |
| HIV 1 and 2 antibody/antigen, HIV viral load | Negative |
Screening Final donation 30–45 days after final donation |
| Hepatitis A IgM | Negative | |
| Hepatitis B surface antigen | Negative | |
| Hepatitis B core antibody, Total and IgM | Negative | |
| Hepatitis C antibody | Negative | |
| Human T-lymphotrophic Virus, type 1 and 2 | Negative | |
| Cytomegalovirus IgG and IgM |
IgM negative If CMV IgG positive, CMV PCR performed on each donated vaginal fluid aliquot |
|
| Herpes Simplex Virus type 1 and 2 IgG antibodies |
HSV2 IgG negative If HSV1 IgG positive, HSV PCR performed on each donated vaginal fluid aliquot |
|
| Epstein-Barr virus heterophile antibody (Monospot) | Negative |
*Normal ranges in Table S1.