TABLE 3.
Sample matrix | Class/substance | Product name | Test concn | Assay result for:a
|
|
---|---|---|---|---|---|
M. genitalium-negative samples | M. genitalium-positive samples (M6604 strain) | ||||
Urine | Whole blood | NAe | 0.4% (vol/vol)b | ND | D |
Urine | Semen | NA | 5.0% (vol/vol) | ND | D |
Urine | Mucus | Mucin | 0.8% (wt/vol) | ND | D |
Urine | Antibiotic | Azithromycin | 1.8 mg/ml | ND | D |
Urine | Analgesic | Paracetamol | 3.2 mg/ml | ND | D |
Urine | Intravaginal hormones | Progesterone; estradiol | 7 mg/ml Progesterone + 0.07 mg/ml beta estradiol | ND | D |
Urine | Leukocytes | NA | 105 cells/ml | ND | D |
Urine | Albumin | Bovine serum albumin | 10 mg/ml | ND | D |
Urine | Glucose | NA | 10 mg/ml | ND | D |
Urine | Bilirubin | NA | 0.18 mg/mlc | ND | D |
Urine | Acidic urine (pH 4.0) | Urine + N-acetyl-l-cysteine | pH 4.0 | ND | D |
Urine | Alkaline urine (pH 9.0) | Urine + ammonium citrate | pH 9.0 | ND | D |
Swab | Over-the-counter vaginal products and contraceptives | Vagisil anti-itch crème (1.0 oz) | 0.25% (wt/vol) | ND | D |
Swab | Over-the-counter vaginal products and contraceptives | K-Y Jelly (4.0 oz) | 0.25% (wt/vol) | ND | D |
Swab | Over-the-counter vaginal products and contraceptives | Options Gynol II vaginal contraceptive gel | 0.25% (wt/vol) | ND | D |
Swab | Over-the-counter vaginal products and contraceptives | Walgreens clotrimazole vaginal cream (1.5 oz) | 0.25% (wt/vol) | ND | D |
Swab | Over-the-counter vaginal products and contraceptives | Vagi-gard douche | 0.25% (wt/vol) | ND | D |
Swab | Over-the-counter vaginal products and contraceptives | Vagisil ProHydrate natural feel internal moisturizing gel (0.2-oz 8 pack) | 0.25% (wt/vol) | ND | D |
Swab | Over-the-counter vaginal products and contraceptives | Vagisil daily intimate deodorant powder (8.0 oz) | 0.10% (wt/vol)d | ND | D |
Swab | Deodorant and powders | Summer's Eve deodorant spray (2.0 oz) | 0.25% (vol/vol) | ND | D |
Swab | Hemorrhoidal cream | Preparation H hemorrhoidal cream (0.9 oz) | 0.25% (wt/vol) | ND | D |
Swab | Prescription-only medicines | Estrace (Estradiol vaginal cream, USP 0.01%) | 0.25% (wt/vol) | ND | D |
D, output result “M. genitalium detected; 23S rRNA mutation detected”; ND, output result “M. genitalium not detected; 23S rRNA mutation not detected.”
Interference may be observed in samples containing >0.4% whole blood.
Interference may be observed in samples containing >0.18 mg/ml bilirubin.
Interference may be observed in samples containing >0.1% wt/vol Vagisil intimate powder.
NA, not applicable.