No 628001

Initiating diagnostic measures and pharmacological treatment in a female with unusual

Developed in collaboration with an advisory committee consisting of Québec clinicians and experts. Validated by the Comité d’excellence clinique en ordonnances nationales of the Institut national d’excellence en santé et en services sociaux (INESSS).

CLINICAL SITUATION OR TARGET POPULATION

Symptomatic female: ► A sexually active female with unusual vaginal discharge with or without pre- or postmenstrual spotting or postcoital bleeding. Asymptomatic sexual partner (male or female)1: ► An asymptomatic individual identified as a sexual partner of a female with laboratory-documented Trichomonas vaginalis .

CONTRAINDICATIONS TO THE APPLICATION OF THIS PROTOCOL

► < 14 years of age; ► Pregnancy, breastfeeding; 2 ► Immunocompromised state ; ► Abnormal uterine bleeding, if: • Menopause; • Bleeding that has persisted for 6 months or longer; • History of gynecological cancer; ► The presence of a contraindication to the use of a recommended drug, with no appropriate alternative; ► Four or more episodes of bacterial vaginosis in the past 12 months (each as evaluated by a physician or a nurse); ► Four or more episodes of vulvovaginal candidiasis in the past 12 months (each as evaluated by a physician or a nurse).

INSTRUCTIONS

1. PRECAUTIONS For a victim of sexual assault, also follow the recommendations in the Guide d’intervention médicosociale.

1 For asymptomatic individuals identified as sexual partners of a female who has been treated pharmacologically for a syndrome consistent with cervicitis, refer to the Protocole national pour le traitement d’une infection à Chlamydia trachomatis ou à Neisseria gonorrhoeae chez une personne asymptomatique. 2 Examples of possible causes of an immunocompromised state (see Appendix V of the Guide québécois de dépistage des ITSS): congenital immune deficiency, leukemia, lymphoma, multiple myeloma, nonhematologic cancer, acquired immune deficiency (such as during HIV infection), hemodialysis, and the use of immunosuppressants.

INESSS | Quebec’s medical protocol – Unusual vaginal discharge 1 2. HEALTH STATUS ASSESSMENT

2.1. Presence of Look for and characterize the following: ► Unusual vaginal discharge; ► Pre- or postmenstrual spotting; ► Postcoital bleeding.

Look for the following: ► Signs and symptoms of a sexually transmitted and blood-borne infection (STBBI) at other sites of exposure. ► Signs and symptoms of a complicated infection (e.g., lower abdominal pain, deep dyspareunia, joint involvement or a deterioration in overall health with fever).

2.2. Medical history

► Pregnancy; ► Voluntary termination of pregnancy (VTP) or an invasive gynecological procedure; ► Date of last menstruation; ► Barrier method of contraception; ► Date and results of last STBBI screening test; ► STBBI history; ► History of bacterial vaginosis or vulvovaginal candidiasis (previous number of episodes, confirmed or not by a physician, nurse or laboratory tests).

2.3. Medication history

► Medication use; ► Drug allergies; ► Use of antibiotics in the past month; ► Hormonal contraception, a levonorgestrel intrauterine system (IUS), a copper intrauterine device, emergency oral contraception.

2.4. STBBI risk factors Inquire about STBBI risk factors and assess the indications for STBBI screening. Consult the tool ITSS à rechercher selon les facteurs de risque décelés.

2.5. Pelvic inflammatory disease risk factors Look for risk factors for pelvic inflammatory disease (PID): ► Having undergone a VTP or an invasive gynecological procedure (e.g., an endometrial biopsy, a hysteroscopy, hysterosonography or hysterosalpingography) in the past month. ► A levonorgestrel IUS or a copper intrauterine device installed in the past month. ► A history of at least one episode of C. trachomatis or N. gonorrhoeae infection in the past year. ► Previous history of PID.

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3. PHYSICAL EXAMINATION

3.1. Overall health and vital signs Take temperature, if warranted.

3.2. Inspection of external genitalia Inspection of the vulva, urethra and perianal region. Look for the following: erythema, edema, fissures, excoriations, or ulcerous, vesicular, erosive, pustular or verrucous lesions.

3.3. Speculum examination Inspection of the and vaginal walls. Describe the unusual vaginal discharge (consult the Comparative table of features consistent with cervicitis, bacterial vaginosis, vulvovaginal candidiasis or trichomoniasis, in Section 5). Look for the following: unusual vaginal discharge, inflammatory appearance of the vaginal walls and cervix, a purulent or mucopurulent endocervical exudate, endocervical bleeding (brittle cervix) or petechiae on the genital mucosa (strawberry cervix).

3.4. Bimanual examination Examination of the uterus and adnexal structures. A bimanual examination is indicated if: ► Pre- or postmenstrual spotting or postcoital bleeding; ► PID risk factors; ► A purulent or mucopurulent endocervical exudate; ► Endocervical bleeding upon swabbing (brittle cervix). Look for the following: lower abdominal tenderness, adnexal tenderness (unilateral or bilateral) or cervical motion tenderness, masses or other structural abnormalities.

4. INVESTIGATION

4.1. Specimens and microbiological tests If unusual vaginal discharge consistent with bacterial vaginosis, vulvovaginal candidiasis or trichomoniasis: ► If a process is in place to provide supervision of the examens de biologie médicale délocalisés (EBMD), obtain a vaginal secretion specimen for a pH measurement and a potassium hydroxide (KOH) amine odour test at the point service3. ► Obtain a vaginal secretion specimen for the appropriate microbiological tests3.

If a purulent or mucopurulent endocervical exudate: ► Obtain a vaginal or endocervical specimen to screen for C. trachomatis and N. gonorrhoeae by nucleic acid amplification testing (NAAT) and an endocervical specimen for an N. gonorrhoeae culture.

If signs or symptoms of pharyngeal or rectal infection: ► Obtain a pharyngeal or rectal specimen (depending on the location of the symptoms) to screen for C. trachomatis and N. gonorrhoeae by NAAT and an N. gonorrhoeae culture specimen.

3 As per the recommendations in the laboratory procedures at the facility concerned. INESSS | Quebec’s medical protocol – Unusual vaginal discharge 3

In the case of sexual practices implying pharyngeal or rectal exposure with no signs or symptoms at these sites: ► Consult the tool Prélèvements et analyses recommandés en fonction de l’infection recherchée chez les personnes asymptomatiques (dépistage).

If risk factors for C. trachomatis or N. gonorrhoeae infection: ► Obtain a vaginal or endocervical specimen to screen for C. trachomatis and N. gonorrhoeae by NAAT and an endocervical specimen for an N. gonorrhoeae culture.

If risk factors for other STBBIs: ► Determine the STBBIs to screen for in accordance with the tool ITSS à rechercher selon les facteurs de risque décelés. ► Obtain the specimen or specimens to screen for the other STBBIs to be checked for according to the tool Prélèvements et analyses recommandés en fonction de l’infection recherchée chez les personnes asymptomatiques (dépistage).

If there is a possibility that the patient is pregnant or if she experiences pre- or postmenstrual spotting or postcoital bleeding: ► Do a urine pregnancy test.

4.2. Details concerning specimens Regardless of type of specimen, it is important to consult the laboratory at the facility concerned for details on the tests used locally (e.g., suitable specimen collection sites, the types of specimens accepted, the applicable specimen collection conditions, storage and transport).

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5. COMPARATIVE TABLE OF FEATURES CONSISTENT WITH CERVICITIS, BACTERIAL VAGINOSIS, VULVOVAGINAL CANDIDIASIS OR TRICHOMONIASIS

C. TRACHOMATIS VULVOVAGINAL AND BACTERIAL VAGINOSIS TRICHOMONIASIS CANDIDIAISIS* N. GONORRHOEAE

Clinical manifestations (none of these infections necessarily presents by all the clinical manifestations listed)

Adherent, Vaginal Thick, curd-like Frothy appearance Purulent homogeneous, fluid discharge Whitish to yellowish Yellowish to greenish Whitish to greyish Malodorous: fishy Odour Nonspecific Nonspecific Malodorous smell

Itching None None or slight Moderate to severe Moderate to severe

Purulent or mucopurulent endocervical exudate Erythema, edema, fissures, excoriations Petichiae on the Pre- or genital epithelium postmenstrual Associated Other Not applicable (strawberry cervix) spotting, postcoital symptoms (pain, bleeding superficial Superficial dyspareunia, dyspareunia, dysuria Endocervical external dysuria) bleeding upon swabbing (brittle cervix epithelium)

Clinical criteria

Vaginal pH Not applicable Vaginal pH > 4.5 Vaginal pH ≤ 4.5 Vaginal pH > 4.5

Amine odour Not applicable Yes No No (with KOH)

Laboratory criteria Nugent’s score ≥ 7‡: Yeast present on wet C. trachomatis vaginal flora consistent Presence of Result mount or Gram with bacterial T. vaginalis N. gonorrhoeae staining vaginosis * Predisposing factor: recent use of antibiotics. ‡ Nugent’s score ≥ 7 or another microbiological test result consistent with bacterial vaginosis.

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6. THERAPEUTIC APPROACH IN THE PRESENCE OF A PURULENT OR MUCOPURULENT ENDOCERVICAL EXUDATE SUGGESTIVE OF CERVICITIS

6.1. Treatment indication

If there is a purulent or mucopurulent endocervical exudate, initiate pharmacological treatment without waiting for the microbiological test results.

Details:

► A bimanual examination is necessary. Promptly refer the patient to an authorized prescriber if she presents with lower abdominal tenderness, adnexal tenderness (unilateral or bilateral) or cervical motion tenderness, masses or other structural abnormalities. ► Initiate pharmacological treatment even in the presence of signs or symptoms at other sites of exposure and the protocol should be stopped since additional investigations are required.

6.2. Preventive interventions, pharmacological treatment, follow-up of the infected individual and support for notifying sexual partners

Consult the optimal usage guide STBBI – Syndromic approach (cervicitis).

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7. THERAPEUTIC APPROACH WHEN A PATEINT TESTS POSITIVE FOR C. TRACHOMATIS OR N. GONORRHOEAE

7.1. Treatment indication Initiate pharmacological treatment upon receiving a positive microbiological test result for C. trachomatis or N. gonorrhoeae (endocervical or vaginal specimen). Details:

► Pharmacological treatment can be initiated if the patient tests positive at other, asymptomatic sites of exposure. 7.2. Preventive interventions, pharmacological treatment, follow-up of the infected individual and support for notifying sexual partners Consult the optimal usage guide STBBI – Uncomplicated Chlamydia trachomatis or Neisseria gonorrhoeae infection.

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8. THERAPEUTIC APPROACH IN THE PRESENCE OF UNUSUAL VAGINAL DISCHARGE CONSISTENT WITH BACTERIAL VAGINOSIS

8.1. Treatment indications Indication No. 1 (during the initial visit (if pH measurement and potassium hydroxide (KOH) amine odour test are performed at the clinic))4 The presence of the following three Amsel criteria5: ► Homogeneous vaginal discharge of milky consistency; ► Vaginal pH > 4.5; ► Amine odour when potassium hydroxide (KOH) is added.

Indication No. 2 (after receiving the laboratory test result) Clinical manifestations consistent with bacterial vaginosis: homogeneous vaginal discharge of milky consistency AND Microbiological test result: a Nugent’s score ≥ 7 (or another microbiological test result consistent with bacterial vaginosis).

8.2. Pharmacological treatment of the infected individual

ST 1 CHOICE

Metronidazole 500 mg PO BID x 7 days

ND 2 CHOICE

Metronidazole, 1 applicator (5 g) containing 0.75% intravaginal gel HS x 5 days (RAMQ: exception drug)6 OR Clindamycin, 1 applicator (5 g) containing 2% intravaginal cream HS x 7 days (RAMQ: exception drug)7

4 Execution of the examens de biologie médicale délocalisés (EBMD) is possible when a process is in place to provide supervision; this process is dependent on the laboratory of the facility concerned. 5 The presence of clue cells on wet mount is another Amsel criterion. 6 The indications recognized for coverage under the RAMQ’s public prescription drug insurance plan are as follows: • For the treatment of bacterial vaginosis in a pregnant woman during the second and third trimesters of pregnancy. • For the treatment of bacterial vaginosis if the patient is intolerant to oral metronidazole. 7 The indications recognized for coverage under the RAMQ’s public prescription drug insurance plan are as follows: • For the treatment of bacterial vaginosis during the first trimester of pregnancy. • When intravaginal metronidazole is ineffective, contraindicated or poorly tolerated. INESSS | Quebec’s medical protocol – Unusual vaginal discharge 8

9. THERAPEUTIC APPROACH IN THE PRESENCE OF UNUSUAL VAGINAL DISCHARGE CONSISTENT WITH VULVOVAGINAL CANDIDIASIS

9.1. Treatment indications

Indication No. 1 (during the initial visit (if pH measurement and potassium hydroxide (KOH) amine odour test are performed at the clinic))8 A previous microbiologically confirmed yeast infection in the past 4 years. AND Clinical manifestations consistent with vulvovaginal candidiasis: ► Thick, white, curd-like vaginal discharge; ► Erythema and edema of the vulvar and vaginal tissues. AND Clinical criteria consistent with vulvovaginal candidiasis: ► Vaginal pH ≤ 4.5; ► No amine odour when KOH solution is added.

Indication No. 2 (after receiving the laboratory test result) Clinical manifestations consistent with vulvovaginal candidiasis: ► Thick, white, curd-like vaginal discharge; ► Erythema and edema of the vulvar and vaginal tissues. AND Microbiological test result: yeast present on wet mount or Gram staining.

9.2. Pharmacological treatment of the infected individual The four pharmacological treatment options are presented in the table below, together with the possible dosage regimens for each option (the intravaginal treatments are listed alphabetically, and the oral treatment is presented at the bottom of the table).

DRUG DOSAGE

CLOTRIMAZOLE* 1 applicator (5 g) containing 1% intravaginal cream HS x 6 days. 1 applicator (5 g) containing 2% intravaginal cream HS x 3 days. 1 applicator (5 g) containing 10% intravaginal cream: a single dose. 1 200-mg intravaginal tablet HS x 3 days. 1 500-mg intravaginal tablet HS x 1 dose. There is the option of concomitant treatment with 1% external cream applied locally on the irritated parts of the genitals: QD - BID PRN for a maximum of 7 days. MICONAZOLE* 1 applicator (5 g) containing 2% intravaginal cream HS x 7 days. 1 applicator (5 g) containing 4% intravaginal cream HS x 3 days. 1 100-mg intravaginal ovule HS x 7 days. 1 400-mg intravaginal ovule HS x 3 days. 1 1200-mg intravaginal ovule HS: a single dose. There is the option of concomitant treatment with 2% external cream applied locally on the irritated parts of the genitals: QD - BID PRN for a maximum of 7 days.

1 applicator (5 g) containing 0.4% intravaginal cream HS x 7 days. TERCONAZOLE There is the option of concomitant treatment with 0.4% external cream applied locally on the irritated parts of the genitals: QD - BID PRN for a maximum of 7 days.

150 mg PO as a single dose. FLUCONAZOLE There is the option of concomitant treatment with an external cream (clotrimazole or miconazole) applied locally on the irritated parts of the genitals: QD - BID PRN for a maximum of 7 days.

* The formulations with a shorter duration of treatment cause more skin irritation.

8 Execution of the examens de biologie médicale délocalisés (EBMD) is possible when a process is in place to provide supervision; this process is dependent on the laboratory of the facility concerned. INESSS | Quebec’s medical protocol – Unusual vaginal discharge 9

10. THERAPEUTIC APPROACH IN THE PRESENCE OF SIGNS AND SYMPTOMS CONSISTENT WITH TRICHOMONIASIS

10.1. Treatment indication

Clinical manifestations consistent with trichomoniasis: yellowish to greenish, frothy vaginal discharge. AND Microbiological test result: presence of T. vaginalis.

10.2. Pharmacological treatment of the infected individual

PHARMACOLOGICAL TREATMENT OF THE INFECTED INDIVIDUAL

Metronidazole 2 g PO as a single dose.

Concurrent infections: Treatment with metronidazole 500 mg PO BID x 7 days is also effective. If oral treatment with metronidazole has been initiated for bacterial vaginosis, contintue the treatment.

10.3. Pharmacological treatment of an asymptomatic sexual partner

The current sexual partners of a female with laboratory-documented Trichomonas vaginalis vaginitis should be treated epidemiologically. Consult the available tools for supporting an infected person so that she can inform her partners.

EPIDEMIOLOGICAL TREATMENT

Metronidazole 2 g PO as a single dose.

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11. THERAPEUTIC APPROACH AFTER RECEIVING THE MICROBIOLOGICAL TEST RESULTS

The therapeutic approaches to be adopted after receiving the results of microbiological tests ordered for one or more of the infections covered by this medical protocol are summarized in the following table.

FEMALE SYMPTOMATIC THE MICROBIOLOGICAL TEST FEMALE ASYMPTOMATIC WHEN THE MICROBIOLOGICAL TEST WHEN THE MICROBIOLOGICAL RESULTS: RESULTS ARE RECEIVED TEST RESULTS ARE RECEIVED Confirm the empirically Provide a follow-up (see Section 12). Monitor the course of the treated infection. symptoms and their duration. The expected time to improvement varies according to the documented infection. If there is no improvement more than 3 days after treatment, stop applying the protocol since additional investigations are required. Ensure adequate management by an authorized prescriber.

Show an infection different • If C. trachomatis, N. gonorrhoeae or T. vaginalis, Initiate a new treatment from the one treated initiate a new treatment. targeting the identified empirically (the • Do not initiate a new treatment if the result received infection (if the symptoms microbiologically is consistent with bacterial vaginosis or vulvovaginal are the same as during the demonstrated infection is candidiasis. Give the patient the result. initial evaluation). covered by this medical protocol).

Do not show the empirically Give the patient the result and tell her to consult a Stop applying the protocol treated infection, and no physician if the symptoms reappear. since additional microbiological test for investigations are required. another infection covered by Ensure adequate this medical protocol has management by an been ordered. authorized prescriber.

Show an infection covered by • If C. trachomatis, N. gonorrhoeae or T. vaginalis, Initiate a treatment targeting this medical protocol but initiate treatment. the identified infection (if the which has not been treated • Do not initiate treatment if the result received is symptoms are the same as empirically. consistent with bacterial vaginosis or vulvovaginal during the initial evaluation). candidiasis. Give the patient the result.

12. FOLLOW-UP

Inquire about adverse effects and monitor the patient for potential interactions with other drugs or substances. Determine if the signs and symptoms persist beyond 48 to 72 hours or reappear after the end of treatment. Order a test of cure in accordance with the recommendations in the optimal usage guide STBBI – Uncomplicated Chlamydia trachomatis or Neisseria gonorrhoeae infection. A test of cure is not recommended in the presence of unusual vaginal discharge consistent with bacterial vaginosis, vulvovaginal candidiasis or trichomoniasis.

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13. SITUATIONS NECESSITING A SUPPLEMENTARY INVESTIGATION

At the time of the evaluation:

► Positive urine pregnancy test. ► Symptoms of a complicated infection: lower abdominal pain, deep dyspareunia, joint involement or a deterioration in overall health with fever (promptly refer patient to an authorized prescriber). ► De novo anogenital verrucous lesions consistent with genital warts. ► Ulcerous, vesicular, erosive or pustular anogenital lesions. ► On bimanual examination: lower abdominal tenderness, adnexal tenderness (unilateral or bilateral) or cervical motion tenderness, masses or other structural abnormalities (promptly refer patient to an authorized prescriber). ► Signs or symptoms at other sites of exposure. The following table contains a summary of the specimens to be collected before stopping the protocol in a female who presents one or more situations requiring supplementary investigation at the time of the evaluation, based on the existence of certain conditions. Thereafter, it is important to ensure adequate management by an authorized prescriber. CONDITIONS SPECIMENS TO BE OBTAINED BEFORE STOPPING THE PROTOCOL AND ENSURING ADEQUATE (MORE THAN ONE CONDITION MAY APPLY) MANAGEMENT BY AN AUTHORIZED PRESCRIBER Lower abdominal pain Urine pregnancy test ► Vaginal (self-collected or collected by clinician) or endocervical specimen to screen Risk factors for C. trachomatis or 9 N. gonorrhoeae infection and unusual for C. trachomatis and N. gonorrhoeae by NAAT AND vaginal discharge ► Endocervical specimen for an N. gonorrhoea culture (if a speculum examination is performed before the patient is referred). Risk factors for C. trachomatis or Pharyngeal or rectal specimen (depending on the location of the symptoms) to screen for N. gonorrhoeae infection and signs or C. trachomatis and N. gonorrhoeae by NAAT and a specimen for an N. gonorrhoeae symptoms of pharyngeal or rectal culture. infection Risk factors for C. trachomatis or Consult the tool Prélèvements et analyses recommandés en fonction de l’infection N. gonorrhoeae infection and recherchée chez les personnes asymptomatiques (dépistage). pharyngeal or rectal exposure with no signs or symptoms at these sites ► Specimen for a viral identification test for the herpes simplex virus (HSV)11. Anogenital ulceration10 ► Syphilis serology.

During or after treatment:

► Intolerance to the medication. ► Persistence of symptoms 48 to 72 hours after the end of treatment. Microbiological test results:

► Positive screening test results for STBBIs other than C. trachomatis and N. gonorrhoeae. ► Negative test result for a suspected infection for which treatment was initiated in a symptomatic female (if she has become asymptomatic by the time the microbiological test results are received, there is no need to refer her to an authorized prescriber). ► Positive test result for C. trachomatis or N. gonorrhoeae at other sites of exposure in a female who has been treated pharmacologically for a syndrome consistent with cervicitis. ► Positive test result for C. trachomatis with a lymphogranuloma venereum (LGV) genotype. ► Positive result on the test of cure.

9 A urine specimen is an acceptable alternative. 10 If anogenital ulceration and STBBI risk factors, request on the requisition that tests be performed to screen for the LGV (lymphogranuloma venereum) genotype if the vaginal or endocervical (or urinary or rectal, if applicable) NAAT results are positive for C. trachomatis. 11 Unless the patient had a viral identification test result (culture or NAAT) that was positive for HSV in the past. Obtaining a specimen early (as soon as lesions appear) is essential for detecting HSV. INESSS | Quebec’s medical protocol – Unusual vaginal discharge 12

14. DECISION ALGORITHM A: PHARMACOLOGICAL TREATMENT IN A FEMALE WITH UNUSUAL VAGINAL DISCHARGE

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15. DECISION ALGORITHM B: PHARMACOLOGICAL TREATMENT IN A FEMALE WITH UNUSUAL VAGINAL DISCHARGE

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DEVELOPMENT PROCESS The development process is based on the triangulation of several data sources, including best clinical practice recommendations and contextual and experiential data.

Four systematic reviews were conducted separately of clinical practice guidelines, consensus reports and health technology assessment reports published between 2011 and 2017. To take current Canadian and Quebec practice into account, the Canadian Guidelines on Sexually Transmitted Infections were selected as well, even if they were published in 2010. Documentation from regulatory agencies or prepared by associations, organizations or professional orders, pharmaceutical product monographs and Health Canada advisories were also consulted. The methodology used to conduct this literature review meets INESSS’s production standards.

The data analysis was performed from a contextualizaton perspective regarding practice in Québec, using experiential data obtained from the health professionals on the advisory committee and the members of the INESSS project team.

INESSS assumes full responsibility for the final form and contents of this medical protocol. The recommendations it contains do not necessarily reflect the opinions of the persons consulted for the purposes of developig this protocol.

INESSS advisory committee:

Dr. Marc Boucher, Obstetrician/Gynecologist Dr. Sylvie Bouvet, Obstetrician/Gynecologist Danielle Gourde, Pharmacist Dr. Annie-Claude Labbé, Microbiologist and Infectious Disease Specialist Éric Lefebvre, Nurse Clinician Dr. Stéphane Roy, Family Physician Dr. Marc Steben, Family Physician Dr. Sylvie Venne, Family Physician Chana Wittenberg, Nurse Clinician

Collaborators: The members of the Comité sur les analyses de laboratoire en lien avec les ITSS (CALI).

Validated by: INESSS’s Comité d’excellence clinique en ordonnances nationales.

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