GeneProof, Diasorin, Bio-Rad
The Complete 12 is our all-encompassing sexual health diagnostic panel that can identify and differentiate between 12 different bacterial and viral infections.
Using a combination of molecular techniques and serological assays, the samples are analysed to differentiate between infections. Swab or urine samples are analysed through a process known as real-time polymerase chain reaction (qPCR). During qPCR any viral or bacterial RNA/DNA present within the sample is amplified using highly specific primer/probe sequences and thermal cycling, while the sample is continuously monitored by software-guided LEDs to quantify the abundance of the target genes. Enzyme Linked Immunosorbent Assay (ELISA) is used to test serum from blood samples and recognizes the presence of specific antibodies and antigens.
Is a common STD caused by the bacteria Chlamydia trachomatis, which is transmitted through sexual contact with an infected individual1. While infection is often asymptomatic, it can lead to complications such as infertility or ectopic pregnancy if left untreated2.
Is transmitted during sexual contact, where it infects any mucous membranes that were exposed to the bacteria. Whether the infection causes a symptomatic response is dependent on the site of infection. Urethral infections often cause painful urination or pustular discharge. However rectal, oral and conjunctivae infections are often asymptomatic and are only diagnosed through screening tests3.
Is a flagellated protozoan parasite that is transmitted through sexual contact with an individual that carries the parasite 4. Symptoms for internal genitals include discharge and localized pain, though about 50% of cases are asymptomatic. If left untreated, complications such as infertility and greater risk of premature labor and miscarriage can occur. While those with external genitals are often asymptomatic carriers, cases exhibiting painful urination and pustular discharge have been reported 5.
Is a species of bacteria that is transmitted during sexual contact where it adheres to the epithelial cells of its new host. It has been shown to cause acute and chronic urethritis in external genitals and can cause cervicitis and pelvic inflammation 6.
Both Ureaplasma parvum and urealyticum cause STDs. Ureaplasma parvum has been linked to an increase in the rates of premature births coinciding with bronchopulmonary disease in the infant 7. In addition, Ureaplasma urealyticum infections are associated with urethritis and pelvic inflammatory disease 8,9. These bacteria are transmitted through sexual contact as well as from an infected pregnant person to child during pregnancy9.
Bacterial vaginosis is caused by the overgrowth of Gardnerella vaginalis, triggered by an imbalance of the bacterial diversity 10. The main cause of this imbalance is sexual contact, as G. Vaginalis can be spread among individuals, altering the natural balance of the bacteria within vagina. The symptoms of Bacterial vaginosis include vaginal odour and mild itching 11. Bacterial vaginosis has also been linked to pregnancy complications such as premature birth or miscarriage 10.
Is caused by the bacteria Treponema pallidum which is transmitted through direct contact with an active lesion or from a pregnant person to child through the placenta 12. In the case of the former, bacteria from the infected person can penetrate mucous membranes, forming an ulcer at the site of contact within 90 days of infection. Syphilis infection through the placenta can introduce serious risk of miscarriage or stillbirth 13.
Are both lifelong, but primarily asymptomatic viral infections that can cause recurring blisters and sores around the site of infection. HSV-1 is transmitted through oral-oral contact with an individual, whereas HSV-2 is transmitted through sexual contact 14.
Both the Hepatitis B and C Viruses (HBV and HCV) attack liver cells upon infection, often leading to cirrhosis over time. HBV has been linked to an increased risk of liver cancer, but the most common symptoms are jaundice, fatigue and vomiting. Both viruses are commonly transmitted from mother to child during birth but can also be transmitted through contact with infected blood during some kinds of sexual contact or through sharing of needles/syringes 15,16.
Is commonly transmitted during sexual contact between mucosal surfaces, or through introduction into the bloodstream via needles/syringes 11. An individual’s symptomatic response to infection depends on the stage of infection. Flu-like symptoms can follow soon after the initial infection, but asymptomatic presentations are not uncommon. Over time, as the immune system is weakened, weight loss, fevers and coughs can develop 12.
HIV-1 / HIV- 2 (p24 antigen and HIV 1/2 antibodies)
Limit of detection
0.075 cp/μl, Chlamydia trachomatis
0.109 cp/μl, Neisseria gonorrhoeae
0.25 cp/μl, Trichomonas vaginalis
1.129 cp/μl, Mycoplasma genitalium
122.124 cp/ml, HSV-I
194.49 cp/ml, HSV-II
0.687 cp/μl, Ureaplasma parvum/urealyticum
0.82 cp/µl, Gardnerella vaginalis
Turn Around Time
*From sample arrival at the laboratory
Each Complete 12 Panel test kit contains:
Genital swab, endocervical swab, urine or urethral swab, clotted blood or serum
95kPa specimen transport bag
Return address labelled UN3373 mailing bag
Sample collection instructions
The Complete 12 is a cost effective and fast way to simultaneously differentiate between twelve viral and bacterial targets and is substantially cheaper than buying each test separately.
We guarantee a same day turnaround from when your sample is received in our laboratory.
Our laboratory is an ISO 15189 accredited clinical laboratory. We adhere to strict internal quality assurance measures and are committed to providing a high-quality service, to consistently deliver clinically valid results.
1. Elwell C, Mirrashidi K, Engel J. Chlamydia cell biology and pathogenesis. Nature Reviews Microbiology. 2016 Jun;14(6):385-400.
2. Schoeman SA, Stewart CM, Booth RA, Smith SD, Wilcox MH, Wilson JD. Assessment of best single sample for finding chlamydia in women with and without symptoms: a diagnostic test study. Bmj. 2012 Dec 12;345.
3. Kirkcaldy RD, Weston E, Segurado AC, Hughes G. Epidemiology of gonorrhoea: a global perspective. Sexual health. 2019 Sep 11;16(5):401-11.
4. Kissinger P. Trichomonas vaginalis: a review of epidemiologic, clinical and treatment issues. BMC infectious diseases. 2015 Dec;15(1):1-8.
5. Bouchemal K, Bories C, Loiseau PM. Strategies for prevention and treatment of Trichomonas vaginalis infections. Clinical microbiology reviews. 2017 Jul;30(3):811-25.
6. Gnanadurai R, Fifer H. Mycoplasma genitalium: a review. Microbiology. 2020 Jan 1;166(1):21-9.
7. Donders GG, Ruban K, Bellen G, Petricevic L. Mycoplasma/Ureaplasma infection in pregnancy: to screen or not to screen. Journal of perinatal medicine. 2017 Jul 1;45(5):505-15.
8. Marovt M, Keše D, Kotar T, Kmet N, Miljković J, Šoba B, Matičič M. Ureaplasma parvum and Ureaplasma urealyticum detected with the same frequency among women with and without symptoms of urogenital tract infection. European Journal of Clinical Microbiology & Infectious Diseases. 2015 Jun;34(6):1237-45.
9. Peretz A, Tameri O, Azrad M, Barak S, Perlitz Y, Dahoud WA, Ben-Ami M, Kushnir A. Mycoplasma and Ureaplasma carriage in pregnant women: the prevalence of transmission from mother to newborn. BMC Pregnancy and Childbirth. 2020 Dec;20(1):1-7.
10. Kairys N, Garg M. Gardnerella. [Updated 2021 Aug 7]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK459350/?msclkid=a2ffc99dc21611ecb8038870d304919
11. Schwebke JR, Muzny CA, Josey WE. Role of Gardnerella vaginalis in the pathogenesis of bacterial vaginosis: a conceptual model. The Journal of infectious diseases. 2014 Aug 1;210(3):338-43.
12. Harmon ED, Robertson EW. Syphilis: A growing concern. The Nurse Practitioner. 2019 Aug 1;44(8):21-8.
13. Tsai S, Sun MY, Kuller JA, Rhee EH, Dotters-Katz S. Syphilis in pregnancy. Obstetrical & gynecological survey. 2019 Sep 1;74(9):557-64.
14. WHO (2022) Herpes simplex virus [cited 21 April 2022]. Available from: https://www.who.int/news-room/fact-sheets/detail/herpes-simplex-virus
15. WHO (2022) Hepatitis B [cited 22 April 2022]. Available from: https://www.who.int/news-room/fact-sheets/detail/hepatitis-b
16. WHO (2022) Hepatitis C [cited 22 April 2022]. Available from: https://www.who.int/news-room/fact-sheets/detail/hepatitis-c
17. Shaw GM, Hunter E. HIV transmission. Cold Spring Harbor perspectives in medicine. 2012 Nov 1;2(11):a006965.
18. WHO (2022) HIV/AIDS [cited 22 April 2022]. Available from: https://www.who.int/news-room/fact-sheets/detail/hiv-aid