Find out more about our tests

How do we measure a test's perfomance?

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HIV tests and their performance

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Sterility and hygiene measures at Open House

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SILENCIOICONO80

Syphilis tests and their performance

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Gonorrhoea, chlamydia and trichomonas tests and their performance

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Hepatitis B tests and their performance

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Hepatitis C tests and their performance

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I want to know more about the window period

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I want information about the inspection of Open House and approval by the authorities

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We are an urban medical centre with an open-minded approach

How do we measure a test's perfomance?

The basic performance standard is measured in two ways:

  • False negatives: Results which are erroneously negative despite the patient having the infection (cases not detected). These false negatives occur because of a limitation in the sensitivity of the test.
  • False positives: Results which are erroneously positive even thought the patient does not have an infection. Th occur because something else has interfered with the result (like having another infection, for example).

We calculate these false positives and negatives comparing each test with the best one available for each disease. Both tests are performed in large groups of patients (a cohort).  Open House has information available for all the tests we use and we will tell you this information prior to chosing a test. These comparisons are performed for your peace of mind, so do ask for the same performance information at any centre you decide to chose for testing.

Queries? Write to us

check opening times

Would you like an appointment at Open House? Call us!

Please see our calendar and check our opening hours before calling.

Calculating the overall performance of our tests

The performance of our tests as shown in our advertising, website, our test reports and when inspected by the regulating health authorities, is based on the results of broad clinical studies that have recruited large numbers with an unknown serological status, in centres of excellence and published in prestigious medical journals, as we describe in our internal protocolo “Rapid Clinical Test Performance Data Sharing” written in July 2012.

We do, however, pay attention to studies of a lesser quality, but considering them relevant to our clinical practice with some caution.

The absolute figure that we quote in our reports, in our website or in other advertising may vary form year to year as new relevant data gets published. If you would like to download our protocol, please click on the icon:

Queries? Write to us

What quality control measures are in place when you do a test in Open House?

What is the approval process for a rapid test in Spain?

Correct indicationIn accordance with health authority guidelines (e.g. gonorrhoea and chlamydia rapid tests don’t work in throat samples due to low detection rates)
Clinical studiesStudies must be performed and published with relevant data (correct design of the study, a good number of patients included, publications in respected journals etc.).
EU approval and CE markingThis will show that it has acheived the same performance as a test in a laboratory. The process is extremely astringent.
Centre approvalThe clinic or laboratory that is going to do tests must be inspected and approved by the local health authorities.
Health professional approvalThe medical staff who are going to request tests must be inspected and approved by the local health authorities. In Spain, blood test request is the exclusive right and responsibility of a doctor.
Correct medical reportsThe results and their interpretation must be signed by the person responsable for doing the tests and the name of the doctor who requested the test must be present.
Quality controlsEach lot of tests should undergo an external and internal quality control inspection as required by Spanish law and the regional laws of Madrid Region and Catalonia. Similarly, a quality control is included in every single test.

Why isn't Open House a laboratory?

Performing rapid tests does not require us to be a laboratory . The Health Council of the Madrid Regional Government and the Department of Health of the Catalan Regional Government have inspected our tests, our protocols and procedures prior to approving our clinics.

Also, in Madrid, we were afforded the status of a Phlebotomy/clinical specimen collection centre having seen our clinical standards.

I was in another clinic and was not seen by a doctor – why not?

To date, Open House has performed some 48,000 rapid tests, each one with prior medical counselling and with the doctor being the person to request the test. We never do irrelevant tests. Tests cannot be done in a laboratory without a doctor’s consent and his/her name should be on the final report form.

You should always demand the same treatment if you are seen in another centre for sexually transmitted diseases. Open House is well aware that you may do tests elsewhere, but they must comply with the law too.

Confused? Please write to us

Check opening times

Would you like an appointment at Open House? Call us!

Please see our calendar and check the opening hours before calling.

Sterility and hygiene measures at Open House

Open House’s main services include the diagnosis and tertament of sexually transmitted diseases. We therefore have procedures in place to guarantee the protection of our patients’ identity, and maintain asepsia en blood extractions. Each time a patient enters that blood-letting room, all materials, needles and test included are all single-use. We can assure the most nervous of our clients who often get very anxious when the need a blood test and therefore were not paying attention to the procedures going on around them, that under no circumstances would we ever put your health at risk.

We are happy to answer any questions you may have about these procedures.

Rapid HIV tests

HIV 1 and 2 rapid antibody blood test

Window period establish by international concensus for this test: 

  •  3 months
 Open House testsPublic Health technique
Median detection elapsed the window period (as most relevant studies):99.99%99.99%
Variance in detection (according to studies of lower quality)97 to 100%
Results delivery15 minutes7 days
False positives:1 in every 3000 tests1 every 300 tests ELISA technique
Experience / additional comments

– This rapid test is the one chosen by health authorities when they do test campaigns in the street or in pharmacies.


HIV 1 and 2 rapid antibody saliva test

Window period establish by international concensus for this test:

  •  3 months
 This test in Open HousePublic Health Technique
Median detection elapsed the window period (as most relevant studies):99.98%99.99%
Variance detection (according to studies of lower quality)92 to 100%
Delivery of Results 20 minutes7 days
False positive: 1 in every 3000 tests1 in every 300 tests ELISA Technique

Experience / additional comments

– The rapid saliva test we use detects almost the same number of cases as the rapid blood test


HIV 1 and 2 rapid antibody blood test in 1 minute

Window period establish by international concensus for this test: 

  •  3 months
 This test in Open HousePublic Health Technique
Median detection elapsed the window period (as most relevant studies):99.98%99.99%
Variance detection (according to studies of lower quality)92 to 100%
Delivery of Results 20 minutes7 days
False positive: 1 in every 3000 tests1 in every 300 tests ELISA Technique
Experience / additional comments

– This technique still does not have the robust data in publications that other tests which have been around for longer have, and it is relatively new in Spain.


HIV 1 and 2 rapid antibody and HIV 1 p24 antigen blood test

Window period establish by international concensus for this test: 

  •  4 weeks
 This test in Open HousePublic Health Technique
Overall detectionaprox. 97 to 99.99%This test is only avaibale in some Spanish regions
Delivery of Results 15 minutes1 week
False positive: 1 in every 3000 tests1 in every 300 tests

Experience / additional comments

To calculate the performance of this tests we have taken note of the results of multiple studies that are available, the clinical recommendations of medical socieities and the manufacturer’s recommendations.
You can read the statement from the Declaración de la British Association on Sexual health and HIV (BASHH)from 15 March 2010 on the usefulness of antibody tests with p24 antigen in the icon below. With European experience in increase, it seems that little by little this rapid technique is going to replace the normal technical to DETERMINE® for its extremely high reliability and ability to close the window period.

Experiencia / comentarios adicionales (a fecha de noviembre 2014)

In studies performed with this test, the absolute detction rate was between 97% and 99.99% of cases. in other words, sometimes the performance is very high and sometimes it isn’t. The reason has been found to be in cases of detection of the HIV-1 subtype c in those patients who are undergoing seroconversion (fullblown flu symtoms), but this subtype of HIV is seen mainly in Southern Africa, West Africa, India, nepal and in some regions of China.

Therefore the new recommendation regarding this test is that, even though it remains and highly sensitive test that is useful for shortening the window period, that all negative results with this test should be double-checked with a normal antibody test at 3 months.

HIV 1 ARN detection by viral load in 90 minutes

Window period establish by international concensus for this test: 

  •  10 days
 This test in Open HousePublic Health Technique
Overall detectionaprox. 99.9%In Spain does not exist still this technique in public health.
Delivery of Results 90 minutes
False positive: 1 in every 3000 tests

Experience / additional comments

This technique searches directly for the virus’ genetic material. Upon detection of these nucleic acids, it makes multiple copies of the ARN to boost a positive signal.

This method is used in the screening of blood donated for transfusions and with its dramatic impact on the “window period”, there are estimates that only one unit of blood in every 2 million may contain undetected HIV.


Once the third day after infection with HIV has gone by, the virus begins to replicate in an exponential fashion. After 10 days, tens of thousands of copies are usually detectable in every milliltre of blood. Our test can detect just 15 copies per millilitre and is therefore considered a highly-sensitive test.
In the past, these genetic tests were susceptible to false positive results (positive results ocurring in someone who is not truly infected) but our new technique is hermetically sealed and therefore cannot be contaminated by other previous blood samples than ran through the system.

Rapid syphilis test

Window period established by international concensus for this test: 

  •  3 weeks
 This test in Open HousePublic Health Technique
Detection (elapsed the window period according our own studies):>99%73 to 86% (single or double technique)
Delivery of Results 15 minutes7 days
False positive: 1 in every 1000 tests1 in every 100 tests

– Our rapid syphilis test is clearly superior to conventional tests in the detection of this disease.

– It can’t be used in people who have had syphilis before, however, and in these cases we need to use an alternative test.

Queries? Write to us

Gonorrhoea, chlamydia and trichomonas tests

Rapid gonorrhoea and chlamydia tests (immunoassays)

Window period established by international concensus for this test:

  • 1 week in the case of gonorrhoea
  • 2 weeks in the case of chlamydia
 Rapid Tests (genital specimens)
Detection (elapsed the window period according to studies published in medical journals):- Chlamydia: aprox. 90%
- Gonorrhea: aprox 90%
Delivery of results: 20 minutes
False positives:- Chlamydia: 1 in 1000 tests
- Gonorrhea: 1 in 200 tests
Experience / additional comments:
  • To understand how we calculate these performance figures please click on the download icon.
  • A positive result in a rapid test allows us to start treatment wihtout having to come back to our clinic
  • However, there are tests which are even more sensitive than our rapid ones. If there is no rush, and you prefer highly sensitive tests we can always do the NAAT tests, sometimes called PCR (see below).

Can we improve detection rates?

Open House imports “flocked swabs” for sample collection. These revolutionary swabs capture much more bacteria than normal ones and therefore greatly increase gonorrhoea and chlamydia detection. Also they are pain-free.

The manufacturer performed a study showing that you can take a sample from the urethra and dilute it 900 times and the test will still be able to detect the infection:

Grey bars: detection with normal swabs

Pink bars: detection with flocked swab

Detection of gonorrhoa and chlamydia DNA with NAAT tests (or PCR)

Detection of gonorrhoa and chlamydia DNA with NAAT tests is unbeatable.

Window period established by international concensus for this test: 

  • 1 week in the case of gonorrhoea
  • 2 weeks in the case of chlamydia
 Genital specimens, throat and assTechnique PAAN in Public Health
Detection (elapsed the window period according to studies published in medical journals): 99,9% In Spain it is not funded this technique widely in Public Health yet.
Delivery of results: 90 minuntes
False positives: 1 in every 200 tests
Experience / additional comments:
  • The highly senstive tests beat all others in detection of gonorrhoea or chlamydia.
  • Open House beats all other clinics in getting results to you, because we can do these tests in just 90 minutes.

To understand how we calculate these performance figures please click on the download icon.

Gonorrhoea and chlamydia infections & the approved and non-approved tests for detection

Throat

Rapid:

NAAT (highly-senstive):

No detection rates low

Yes

but only if a system which avoids cross-reactions with other throat

bacteria is employed. (searching for two specific nucleic acids). At Open House, our highly sensitve gonorrhoea and chlamydia tests have this system incorporated.

Cervix

Rapid: Yes

NAAT (highly-senstive): Yes

Urethra

Rapid: Yes

NAAT (highly-senstive): Yes

Rectum

Rapid:

NAAT (highly-senstive):

No too many false positives

Yes

but only if a system which avoids cross-reactions with other throat bacteria is employed. (searching for two specific nucleic acids). At Open House, our highly sensitve gonorrhoea and chlamydia tests have this system incorporated.

 Pruebas RápidasPAAN (ultrasensibles)
GargantaNo, no alcanzan suficiente detección, siempre y cuando tengan un sistema para evitar reacciones cruzadas con otras bacterias en la garganta (una búsqueda de dos ácidos nucléicos específicos). En Open House, nuestras pruebas ultrasensibles de gonorrea y clamidia tienen este sistema incorporado
Cuello de útero
Uretra
RectoNo, demasiados falsos positivos, siempre y cuando tengan un sistema para evitar reacciones cruzadas con otras bacterias en la garganta (una búsqueda de dos ácidos nucléicos específicos). En Open House, nuestras pruebas ultrasensibles de gonorrea y clamidia tienen este sistema incorporado

Trichomonas tests

 Open House rapid testConventional tests
Median detection elapsed the window period (studies published in medical press):93,6%- Culture: 83%
- Microscopy: 53%
Results delivery:15 minutos7 días
False positives:1 in every 200 testsInexistent
check opening times

Would you like an appointment at Open House? Call us!

Please see our calendar and check our opening hours before calling.

Rapid Hepatitis B tests

In Open House, we always do two hepatitis B tests at the same time. We look for antigen (in other words evidence of the active virus) and antibodies (evidence of past infection or having been vaccinated).

We have acquired the first rapid hepatitis B test to be awarded the CE mark. To understand how we calculate these performance figures please click on the download icon.

Window period established by international concensus for this test:

  • 4 weeks
 Open House rapid Teststraditional tests
Detection elapsed the window period (as most relevant studies):- Antigen 99,8%
- Antibodies 99%
- Antigen 99,8%
- Antibodies 99%
Results delivery 20 minutes7 days
False positives- Antigen 1 in 1000 tests
- Antibodies 1 in 500 tests
- Antigen 1 in 1000 tests
- Antibodies 1 in 500 tests

Queries? Write to us

Hepatitis C tests

Warning!:

before making a decision about testing, see window periods you should follow to get the results of maximum reliability.I want to know more!

Window period established by international concensus for this test:

  • Antibodies 3 months
  • PCR 15 days
 Open House TestsPublic Health Technique
Detection (respecting the window period according to studies published in medical journals):- Antibodies: 99%
- PCR: 99,9%
- Antibodies: 99%
- This test does not exist
Results delivery- Antibodies: 20 minutes
- PCR: 10 days
- Antibodies: 7 days
- This test does not exist
False positives- Antibodies: 1 every 500 tests
- PCR: 1 every 200 tests
- Antibodies 1 every 500 tests
- This test does not exist

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