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Objective
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has infected more than 2 million people, caused thousands of deaths, and become a worldwide pandemic. To effectively block its transmission, all possible transmission routes must be determined. SARS-CoV-2 has been identified previously in throat and anal swabs, urine, and tears. However, little has been reported about SARS-CoV-2 in the female genital tract, which may provide direct evidence on sexual and mother-to-child transmission. This study aimed to determine whether SARS-CoV-2 exists in the lower female genital tract (including vaginal fluid and cervical exfoliated cells).
Study Design
In this study, we recruited 35 women with coronavirus disease 2019 (COVID-19) from Jan. 28, 2020, to Feb. 18, 2020, in 3 branches of the Tongji Hospital: Sino-French New City Branch (16 cases), Optical Valley Branch (16 cases), and Hankou Main Campus (3 cases). Patients received a diagnosis of COVID-19 based on the New Coronavirus Pneumonia Prevention and Control Program (5th edition) published by the National Health Commission of China (NHCC). Written informed consent was obtained from each enrolled patient.
A total of 27 patients had a positive result for SARS-CoV-2 by reverse transcription polymerase chain reaction (RT-PCR) analysis on samples from the respiratory tract, which were consistent with the interim guidelines of the World Health Organization (WHO). Eight patients received a clinical diagnosis of COVID-19 based on the NHCC guidelines, as mentioned previously. It was a special situation in Wuhan, China, that many patients received a clinical diagnosis of COVID-19 and were admitted to COVID-19–specific hospitals based on the NHCC guidelines. Patients had typical epidemiologic histories, symptoms, and computed tomography scans but lacked throat swabs with positive results. These patients were included to investigate if SARS-CoV-2 could be found in the genital tract considering that it was difficult to detect in the upper respiratory tract.
To avoid false-negative results, 3 different types of samples were obtained from each patient, including vaginal fluid, exfoliated cell, and anal swab. Each type of sample was collected twice and tested at 2 separate laboratories. Vaginal fluid samples were obtained from the posterior vagina fornix using a speculum. Swabs were rotated for 5 seconds and extracted while rotating (sampling kit from Yocon, Beijing, China). Exfoliated cell samples were collected from the cervix (or vaginal residue of patients who had undergone hysterectomy) according to the protocol of the ThinPrep cytologic test (Hologic, Marlborough, MA). The anal swab was inserted 3 cm into the anal canal and rotated for 5 seconds (sampling kit from Yocon, Beijing, China). None of the patients were admitted to the intensive care, and none had invasive ventilation; all had the ability to cooperate completely and to assume a lithotomy position, to follow the standard gynecologic examination protocol during sampling. Following the WHO guidelines for real-time RT-PCR, all samples were tested for SARS-CoV-2 using the recommended Chinese Center for Disease Control and Prevention kit (Daan Gene, Guangzhou, China, or BioPerfectus Technologies, Jiangsu, China). All the samples were processed separately and simultaneously at Tongji Hospital, Department of Clinical Laboratory, Wuhan, China, and Wuhan KDWS Biological Technology Co, Ltd, Wuhan, China. Sample collection, processing, and laboratory testing followed WHO guidelines. Positive cases were defined as patients with a positive test result from either laboratory.
Results
The age range of the 35 patients was 37–88 years. Most patients were natives of Wuhan, China. More than 50% of patients had chronic diseases. The interval from the first symptoms of COVID-19 to the time of taking the samples varied between 8 and 41 days. Twenty-eight patients had entered the menopause stage. One patient was postpartum and had just undergone a cesarean delivery. As a consequence, the sampling covered women who were postpartum and postmenopausal and women of reproductive age ( Table ).
| Patient no. | Age, y | Menopause | Days from first symptoms to sampling | Throat swab | Vaginal fluid | Cervical exfoliated cells | Anal swab |
|---|---|---|---|---|---|---|---|
| 1 | 74 | Yes | 24 | + | − | − | − |
| 2 | 60 | Yes | 27 | + | − | − | − |
| 3 | 59 | Yes | 36 | + | − | − | − |
| 4 | 64 | Yes | 31 | + | − | − | − |
| 5 | 60 | Yes | 21 | − | − | − | − |
| 6 | 75 | Yes | 23 | + | − | − | − |
| 7 | 88 | Yes | 26 | + | − | − | − |
| 8 | 46 | No | 26 | + | − | − | − |
| 9 | 56 | Yes | 27 | + | − | − | − |
| 10 | 69 | Yes | 26 | + | − | − | − |
| 11 | 56 | Yes | 25 | + | − | − | − |
| 12 | 55 | Yes | 25 | − | − | − | − |
| 13 | 70 | Yes | 31 | + | − | − | − |
| 14 | 48 | No | 28 | + | − | − | − |
| 15 | 37 | Postpartum | 28 | − | − | − | − |
| 16 | 71 | Yes | 31 | + | − | − | − |
| 17 | 71 | Yes | 41 | − | − | − | − |
| 18 | 56 | Yes | 20 | + | − | − | − |
| 19 | 41 | No | 23 | + | − | − | − |
| 20 | 73 | Yes | 22 | + | − | − | − |
| 21 | 63 | Yes | 14 | − | − | − | − |
| 22 | 67 | Yes | 21 | − | − | − | − |
| 23 | 51 | No | 24 | − | − | − | − |
| 24 | 44 | No | 21 | − | − | − | − |
| 25 | 76 | Yes | 22 | + | − | − | − |
| 26 | 63 | Yes | 13 | + | − | − | − |
| 27 | 69 | Yes | 9 | + | − | − | − |
| 28 | 65 | Yes | 11 | + | − | − | − |
| 29 | 44 | No | 14 | + | − | − | − |
| 30 | 64 | Yes | 8 | + | − | − | + |
| 31 | 53 | Yes | 15 | + | − | − | − |
| 32 | 66 | Yes | 26 | + | − | − | − |
| 33 | 67 | Yes | 29 | + | − | − | − |
| 34 | 67 | Yes | 26 | + | − | − | − |
| 35 | 66 | Yes | 26 | + | − | − | − |
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