Information for medical professionals

With expertise, consulting and support, s.a.m health supports the healthcare system

s.a.m health offers asymptomatic individuals with a history of sexually transmitted infections easy and discreet access to regular testing (screening) for HIV, syphilis, gonorrhea and chlamydia infections.

Professional consultation

After initial registration, the first step is a consultation with an experienced counselor from a partner checkpoint of the German Aids Federation. During the consultation, it is evaluated whether s.a.m health is the ideal service for the interested party and at what interval tests for HIV and STI are recommended based on the individual risk of infection.

People with symptoms of an STI should - this is also part of the counseling - not get tested via s.a.m health, but are asked to visit a doctor's office immediately.

In the event of a reactive or positive finding, a further consultation is conducted by the partner checkpoint with referral to medical care.

Quality assured laboratory analysis

Laboratory tests for HIV, syphilis, gonorrhea and chlamydia are ordered as in the office-based medical setting.

Test for HIV (AG/AK): Cobas 8000 test device; Elecsys HIV Combo PT (Roche)

The 5th Generation HIV Screening Test is a combination test for the detection of HIV-specific antibodies and p24 antigens. In the reactive case, the results of the antibody and antigen components of the test are reported separately. The screening test detects all groups and subtypes of HIV-1 as well as HIV-2.

Performing an HIV antigen-antibody test is useful at the earliest two weeks after sexual exposure. Six weeks after the risk contact, the result is considered sufficiently reliable (diagnostic window).

In the case of a reactive screening test, a confirmatory test is mandatory: either as an immunoblot (for the presentation of various antibodies against HIV-1/2 and/or as a direct virus detection by means of nucleic acid detection (NAAT, e.g. as PCR). At s.a.m health, the confirmatory test is carried out from the reserve sample without any further costs for our users.

Lues (Syphilis) Test: TPPA with Serodia PR-PA (Fujirebio)

The Treponema pallidum particle agglutination test (TPPA test) is used as a screening test in individuals without a history of syphilis and detects both IgM and IgG antibodies. The TPPA test shows a reactive result no earlier than two to three weeks after infection. The exclusion of syphilis by means of the TPPA test is possible after ten weeks (diagnostic window).

In the event of reactive findings, the patient is then referred to the doctor's office for a confirmatory test for Treponema pallidum IgM and IgG antibodies and for cardiolipin antibodies as markers of inflammatory activity. These complex tests require venous blood sampling - the capillary blood sample taken during s.a.m health is not sufficient for this purpose.

Lues (syphilis) test in case of known cured syphilis: RPR (Rapid Plasma Reagin Test) with Reditest (Biokit)

If syphilis is recorded in the medical history during the initial consultation, a different test procedure is used in the laboratory. In these cases, TPPA would be unsuitable as a screening test, since IgG antibodies are usually detectable in the TPPA test for life after a cured syphilis. Renewed syphilis can then be detected by detecting cardiolipin antibodies in the RPR test.

Detectable antibodies in the RPR test indicate syphilis requiring treatment. Cardiolipin-AK are detectable in serum about four to six weeks after a syphilis infection.

In the case of reactive findings, the users are also referred to the medical practice during the consultation in order to perform the examination for Treponema pallidum IgM and IgG antibodies as a confirmatory test and again an examination for cardiolipin antibodies (for titre control).

In reinfection, IgM antibodies may be absent from the findings. Serological follow-up should be performed 2-4 weeks after therapy and then at three-month intervals. A decrease, especially in cardiolipin antibodies, by 3-4 titer levels within one year indicates effective therapy. These treatment and follow-up controls are not the aim of s.a.m health's testing services, and users with a corresponding medical history are referred from the consultation to the doctor's office.

Test for Chlamydia and Gonorrhea: NAAT with Cobas 4800 CT/NG Test (Roche)

The nucleic acid assay (NAAT) is the reliable and rapid way to detect or exclude Chlamydia Trachomatis (CT) and Neisseria Gonorrhoea (NG). Chlamydia Trachomatis is the most common sexually transmitted bacterial pathogen. Dual infections with gonococci (Neisseria gonorrhoea) occur in 10-30% of patients. Nucleic acid amplification tests (NAAT) for CT and NG have a significantly higher sensitivity compared to culture, antigen tests and gene probe tests; in the case of NG, this is particularly true for the extragenital sites.

In addition to the urethra and cervix, the pharynx and rectum can be considered as further sites of infection. CT and NG infections in the pharynx and rectum are asymptomatic or asymptomatic in >90% of infected individuals, but can still be passed on. Pathogen detection in NAAT is not dependent on their vitality.

In the case of s.a.m health, urethral diagnostics are performed via first-stream urine in people with a penis, and via a vaginal swab in people with a vagina. In addition, swabs are taken from the pharynx and rectum. In terms of sensitivity, there are no significant differences between first-stream urine and urethral swabs in people with penises. In people with vagina and uterus, vaginal and cervical swabs are considered equivalent.

The samples from all three smear locations are pooled in the laboratory for better cost efficiency. Thus, in the case of a positive finding, it is not possible to say from which localization the positive finding originated. However, the therapy is the same for all three localizations in case of a proven infection.

In the case of a positive NG result, additional cultural detection should be sought in medical practice due to the possibility of resistance testing.

Sensitivity and specificity of the laboratory tests used at s.a.m health

Accredited laboratory

The last periodic re-accreditation of the Lademannbogen laboratory commissioned by us took place in August and September 2018 by the German Accreditation Body (DAkkS). The DAkkS has been designated as the only national accreditation body by the Federal Government since 01.01.2010. The current certificate according to the updated standard DIN EN ISO 15189:2014 was issued on 01.04.2019 and is valid until the cancellation of the standard in the specified issue status.

Trustworthy support and cooperation in the healthcare sector

Our service was developed with the needs of users and the challenges of the German healthcare system in mind. Demographic change with an aging and increasingly multi-morbid population is confronted with a shortage of physicians. Both factors make it more difficult to ensure long-term medical care.

s.a.m health supports physicians by easing their daily workload. The service around regular screening for STI and HIV enables asymptomatic patients with a risk profile and a high interest in (sexual) health to handle it in a self-determined way. In case of infection, our users are encouraged to seek treatment at a medical practice.

This allows physicians to focus more on diagnosing symptomatic patients and treating infections detected (and earlier if regular screening is performed), while s.a.m health provides sexual health education, counseling, and testing.

Transition from s.a.m health to office-based medical care

Positive or reactive test results are always communicated by phone or in person at s.a.m health. In this case, our users receive an SMS with a request to call back or to make an appointment. In this way, the colleagues in the counseling centers can respond to the users in a reassuring and competent manner and immediately clarify questions that arise and alleviate widespread fears.

In addition, we collaborate with specialized medical practices and refer our users to physicians for treatment if they do not have a treating physician to contact directly.

In the case of a serious test result (HIV), our counselors support the user in making an appointment at a specialized HIV practice and accompany the user to the appointment if desired.

You have further questions about s.a.m health? In our FAQ you will already find many answers.

If you would like to offer s.a.m health in your practice or have further medical questions about our services, please contact Armin Schafberger, Medical Director Deutsche Aidshilfe: armin.schafberger@dah.aidshilfe.de.

References:

[1] Merck Sharp & Dohme Corp. Verstehen von Medizinischen Tests und Testergebnissen. Available from: https://www.msdmanuals.com/de/profi/spezielle-fachgebiete/klinische-entscheidungsfindung/verstehen-von-medizinischen-tests-und-testergebnissen.

[2] Roche Diagnostics. Elecsys® HIV Duo. Immunoassay for the qualitative determination of HIV p24 antigen and antibodies to HIV; Available from: https://diagnostics.roche.com/global/en/products/params/elecsys-hiv-duo.html.

[3] Roche Molecular Systems, I. cobas 4800 CT/NG Test. Performance Characteristics; Available from: https://soacare.nl/wp-content/uploads/2015/12/05641233001-04EN.pdf.

[4] Fujirebio. Treponema pallidum Line Immunoblot. Details. About Treponema pallidum and syphilis (Lues); Available from: https://www.fujirebio.com/en/products-solutions/treponema-pallidum-line-immunoblot.

[5] company., B.A.W., RPR reditest, in Rapid test for the qualitative and quantitative detection of syphilis in serum or plasma.