Table 1 Overview of donor screening tests.

From: Screening and characterization of vaginal fluid donations for vaginal microbiota transplantation

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

  1. *Normal ranges in Table S1.