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Gonorrhoea Screening Test Instructions

NOT FOR INTERNAL USE (Self Test – For Home Use IN-VITRO DIAGNOSTIC USE ONLY)

Why do this test?

The intended use of this test is to detect the presence/absence of N. Gonorrhoea (bacteria) in a freshly voided early morning urine sample provided by the user of this self-test kit. The presence of the bacteria in urine is an indication of Gonorrhoea infection, as these organisms are not normally found if the test results are positive. It is advisable to visit a GUM (Genitourinary Medicine) clinic or your GP (General Practitioner) to obtain suitable antibiotic treatment as soon as possible.

Because gonorrhoea is a threat to your health if left untreated.
Because there is now an accurate laboratory test for the infection using a urine sample.
Because the infection can be easily treated, thereby preventing long term complications such as pelvic inflammatory disease as well as preventing infection of partners.

What is Gonorrhoea Infection?

Gonorrhoea is one the commonest sexually transmitted bacterial infections which affects both males and females.

The bacteria causing the infection called gonococcus, is passed on through unprotected sexual intercourse. Not everyone who catches Gonorrhoea will have symptoms but if you have an infection you may experience pain when passing urine and notice a creamy/white discharge (from the penis or vagina). If you have unprotected sex with someone who has gonorrhoea you run the risk of being infected. This may result in: 1) development of the symptoms. 2) No symptoms but you may carry the organism and pass it on to someone else or 3) Chronic infection where the organism may cause long-term complications without any signs of acute symptoms.

In women, symptoms, if present are often clear including change in vaginal discharge often heavier and more striking than usual, pain on passing urine and spotting between periods or bleeding after sex. Sometimes women get pain in the lower abdomen, indicating possible pelvic inflammatory disease (PID), which may be caused by Gonorrhoea.

Symptoms in men range from an obvious discharge from the urethra (pipe) in the penis and/or severe pain on passing urine, to very mild irritation at the end of the urethra. Men can suffer from swollen testicles as a result of this infection (epididymitis, or epididymo-orchitis).

It is important to remember that when symptoms have gone away the infection may remain and can be passed on to another sexual partner if no protection is used.

This leaflet also contains instruction on how to collect your urine sample needed to perform the lab analysis successfully.

Check that your kit contains

Plastic pouch with snap top seal and two pockets.

A plastic tube, lined with an absorbent material in case of leakage.

A urine sample bottle with a screw top.

Client Information Form.

Postage paid envelope addressed to:

TDL (The Doctors Laboratory)
60 Whitfield Street
London
W1E 4BR

Check that the test reference number on the sample bottle, and client information form are the same, if not then do not proceed. Contact the supplier for a replacement test. The number is unique and has been allocated to you. Please keep a note of the reference number used on the client information form in case you need to contact us.

Instructions for use

Read carefully before proceeding

Please take the time to read this information sheet telling you about Gonorrhoea, particularly regarding the advice as to what you should do when you receive your results.

A urine specimen is required to test for the presence of gonococcus bacteria.

The test laboratories is closed on Sundays so to minimise the chances of any delay in processing your sample, we advise that you should collect a urine sample in the morning, Monday to Wednesday and post it as soon as possible after collection.

The urine sample must not be kept at room temperature for longer than necessary – if there is any delay in posting please place it in the fridge (not freezer). The sample must be processed within 5 days.

Collecting the urine sample

Do not collect until at least two hours has elapsed since you last passed urine, it may be easier to collect it first thing in the morning.

Remove the screw top from the sample collection bottle. Start to urinate into the bottle, making sure that you catch the first drops of urine you pass. Continue until the bottle is full, allowing about an inch off the top (there is a line at the 20ml level) and then finish urinating into the toilet.
Screw the top back onto the container tightly to avoid leakage during transport.
Write your name, date and time of collection of the sample on the bottle label in the space provided.
Complete the client information form, providing any missing information, especially the date of collection of the sample.
Place the bottle back in the plastic tube. Insert the absorbent material and firmly close by pressing the holder together.
Place the plastic tube into one side of the plastic pouch and place the client information form in the other. Press the edges of the plastic together to seal.
Place the plastic pouch inside the plastic postal envelope and seal by peeling of the dividing plastic strip and press the edges on the adhesive to seal.
This envelope is pre-addressed and pre-paid. Post it as soon as you can.

Limitations/cross reactions

The presence of high levels of red blood cells in the urine sample may interfere with the analysis producing false negatives, do not submit samples if you are experiencing your menstrual period.

The lubricants like Replens® have been shown to inhibit the analysis and may result in false negative results. Wash and remove all possible traces of such lubricants prior to sample collection.

Do not urinate for two hours before collecting your test sample.

It is recommended that the best urine sample for analysis is one called “early morning first-catch urine”, which means when you go to the toilet first thing in the morning you take a sample from the first few drops of urine, this sample ensures the best possible outcome from laboratory analysis.

PCR testing is not intended to replace cervical exam and endo-cervical sampling for the diagnosis of urogenital infections. Conditions such as cervicitis, urethritis and urinary tract or vaginal infections due to other causes or concurrent infections with other agents.

How do I receive my results?

In order to receive your results promptly, please ensure that your name and address is clearly written on the client information form. A hard copy of the result will be sent to your home address.
You will not be given your results by telephone.
If you require any further information please contact your GP (General Practitioner) or Pharmacist, who will be more able to assist you in more detail.
This advice is in no way meant to replace qualified medical advice.

Interpretation of Results

Your urine sample will be tested using the Polymer Chain Reaction (PCR), one of the most accurate tests available at present. To ensure maximum confidentiality, your report will be sent to you through the post. Please note that results cannot be given over the telephone. There are 4 possible results:

PCR NEGATIVE: This means that Gonorrhoea was not detected in the urine sample you provided. It is important to remember that, however good a test is you can occasionally get a negative result, when you do in fact have the infection. If you remain concerned, it may be sensible to attend a GU (Genitourinary) clinic or consult your GP (General Practitioner). If you have a repeat test done, it may give a different result depending on what specimen and test methods are used.

PCR POSITIVE: This means that you almost definitely have a Gonorrhoea infection and you need to start treatment with a course of antibiotics as soon as you can. It is possible that you could have a positive result when you do not have the infection, but this is very rare with the test methods used. The best course of action is to attend a GU (Genitourinary) clinic, where Health Advisors are available to discuss Gonorrhoea and other sexually transmitted diseases with you. You can find the nearest GUM (Genitourinary Medicine) clinic in the telephone directory, or via your local hospital. Book an appointment and take your result letter with you. If you do not wish to attend a GU (Genitourinary) clinic then your GP (General Practitioner) can prescribe antibiotics for you. If you have a repeat test done, it may give a different result depending on what specimen and test methods are used, it is very important that your sexual partner(s) is also treated or you are likely to become re-infected when you have sex. Make sure that you do not have unprotected sex until treatment is complete.

PCR EQUIVOCAL: This occurs when the laboratory cannot provide a definite result. In these cases the safest course of action is to repeat the test on a fresh specimen, although the vast majority prove to be negative on re-testing. In the event of your test proving to be equivocal a new test will be sent to you automatically. Factors causing equivocal results are often outside anyone’s control but to assist the laboratory to obtain the best results it is preferable to send the first urine sample passed in the morning or wait until your bladder is full (at least two hours after urination) before collecting the sample. It should also contain the first drop of urine passed and be posted as soon as possible after collecting.

SAMPLE OUT OF PROTOCOL : This means that the sample was more than 5days old when it arrived in the laboratory for testing.

Limitations

The use of antibiotics in the previous 5-7 days may result in abnormal results being obtained.

If you do not receive your results within 14 days of posting the sample please contact the Simplicity Health Ltd. Helpline on: 08700 349 606 or by e-mail : Info@simplicityhealth.co.uk

This screening test relies upon detection in a biological system therefore it is possible that it may not be 100% accurate in every case. Occasionally the test may produce a false positive or a false negative result. As with all screening tests therapeutic decisions should not be based on any single result or method. In the case of unexpected results or symptoms consult your doctor or pharmacist for advice.

How can I avoid getting Gonorrhoea?

Gonorrhoea is a common infection that can have serious complications. It is important to try not to catch it in the first place and avoid getting re-infected. Condoms can stop the infection being passed on. The condom must be used correctly and be put on before any genital contact, to be of any use in preventing infection. If you feel that you would like to stop using condoms then your partner can have a test, either through a testing service such as the offered by Personal Screening or via a GU (Genitourinary)/Sexual Health Clinic. Remember, each time you have unprotected sex with a new partner you run the risk of being infected so you should be retested under these circumstances.

As Gonorrhoea is a sexually transmitted infection it is very important that you do not have sexual contact whilst taking the treatment, and that you get your partner(s) treated. If you do not ensure that your partner is treated or have taken part in unprotected sex with a new partner, you may get re-infected and you may develop more serious complications as a result.

How is Gonorrhoea treated?

Gonorrhoea is easily treated with a course of antibiotics; treatment should be sought from your GP (General Practitioner) or GUM (Genitourinary Medicine) clinic. If it is not possible for you to take these for any reason then alternatives are available.

How can I get my partner(s) checked?

In the United Kingdom there is a network of clinics called “Genitourinary Medicine Clinics” (GU Clinic) or “Sexual Health Clinics”. These are listed on the website www.agum.org.uk under A-Z Directory of GU (Genitourinary) clinics or contact your local hospital. You can seek advice from Health Advisers, who work within the clinics, which are confidential and free, and you can have a check for other sexually transmitted infections as well as Gonorrhoea.

You are strongly advised to get your sexual partner(s) checked either at a GU (Genitourinary) Clinic or by their GP (General Practitioner) to ensure that they receive appropriate treatment if necessary.

What happens if I do not want to attend a GU (Genitourinary) clinic?

If you go to your General Practitioner (GP) with the result of the test, they will be able to give you an appropriate course of antibiotics.