CDC Zika Health Advisory: Prolonged IgM response and Testing Results in Pregnancy
SUMMARY:
On May 5, 2017, the CDC released an urgent public health advisory regarding prolonged IgM response and subsequent consequences related to Zika testing in pregnancy. Based on emerging data, it appears that IgM may remain in the system > 12 weeks, therefore complicating estimates as to when infection may have occurred, particularly in asymptomatic individuals
KEY POINTS:
Promptly test any pregnant women with concurrent NAT and serologic testing as soon as possible through 12 weeks after symptom onset if they become symptomatic during their pregnancy or if a sexual partner tests positive for Zika virus infection
Asymptomatic pregnant women living in or frequently traveling to areas with Zika virus transmission
Consider Zika NAT testing at least once per trimester in addition to IgM testing as previously recommended
Consider Zika NAT testing if performing amniocentesis
Consider IgM testing to determine baseline Zika virus IgM levels as part of preconception counseling
Counsel pregnant women each trimester on the limitations of IgM and NAT testing
Interpreting Zika NAT results:
Positive – may indicate recent infection
Negative – does not rule out recent infection as viral RNA declines over time
The CDC has not changed guidance for symptomatic individuals at this time. The Advisory states:
Although IgM persistence could affect IgM test interpretation for all infected people, it would have the greatest effect on clinical management of pregnant women with a history of living in or traveling to areas with Zika virus transmission before conception. Pregnant women who test positive for IgM antibody may have been infected with Zika virus and developed an IgM response before conception.
CDC Guidance for Non-Pregnant Patients and Available Diagnostic Tests for Zika Virus
Zika virus disease is a nationally notifiable condition:
Healthcare providers should report suspected Zika virus disease cases to their state, local, or territorial health department to facilitate diagnosis and mitigate risk of local transmission. State, local, and territorial health departments should report laboratory-confirmed and probable cases to CDC.
CLINICAL ACTIONS:
The following is a summary of CDC testing protocols. For detailed protocols and information, the CDC resource pages can be found in the Learn More – Primary Sourcessection below
Testing Guidance for Non-Pregnant patients
Symptomatic individuals with possible exposure to Zika virus
CDC defines ‘exposure’ to Zika virus as travel or residency in an area of active Zika virus transmission or sexual intercourse without a condom with a parter who has lived in or traveled to such an area
Concurrent testing of serum and urine by Zika virus ribonucleic acid (RNA) nucleic acid testing (NAT) and Zika virus and dengue virus IgM testing of serum is recommended
NAT testing is dependent on the timing of specimen collection
NAT testing should be performed on specimens collected <14 days after symptom onset
NAT testing is not recommended on specimens collected ≥ 14 days after symptom onset
Zika virus and dengue virus IgM serology testing should be performed on NAT negative samples collected <14 days after onset of symptoms or on samples collected ≥14 days after onset of symptoms
SYNOPSIS:
Testing for Zika virus is available using molecular and serological assays. Typical symptoms include acute onset of fever, with maculopapular rash, arthralgia, myalgia, headache, conjunctivitis. Differential diagnosis of such symptoms is broad and include group A strep, rubella, measles and other viral diseases. Therefore, to identify those at risk for Zika virus, it is essential to take a travel and sexual history of all patients presenting with the above symptoms and to stay current with CDC updates as to high Zika virus transmission areas.
A molecular test designed to detect Zika virus, Dengue virus and Chikungunya virus RNA
FDA is currently allowing its use under an Emergency Use Athoriziation
RNA can be detected in the acute phase, and up to 14 days post symptoms in urine
If clinically indicated, amniocentesis and CSF specimens may be tested alongside patient-matched serum sample
Antibody Detection Methods: Zika virus IgM
Antibody testing not required if there is a a positive rRT-PCR result
Due to cross reactivity, symptomatic individuals should be tested for anti-Zika and anti-Dengue IgM and where clinically relevant, anti-chikungunya IgM
PRNT (Plaque Reduction Neutralization Test) to confirm antibodies
Works by quantifying the antibodies that neutralize the virus
Positive or equivocal IgM results must be confirmed with an antibody neutralization assay to rule out false positives (previous and not recent infection)
Not necessary with positive rRT-PCR which is definitive
Test is performed by the CDC or CDC approved lab
PRNT may not be able to provide definitive determination of the specific virus causing the recent infection
Trichomoniasis: CDC Diagnosis and Treatment Guidelines
SYNOPSIS:
Trichomoniasis is the most prevalent nonviral sexually transmitted infection worldwide.The U.S. population-based T. vaginalisprevalence is 2.1% among females and 0.5% among males, with the highest rates among Black females (9.6%) and Black males (3.6%), compared with non-Hispanic White women (0.8%) and Hispanic women (1.4%)The majority of persons who have trichomoniasis (70%–85%) either have minimal or no genital symptoms, and untreated infections might last from months to years, however, data are lacking on whether screening and treatment for asymptomatic trichomoniasis is beneficial. Decisions about screening might be informed by local epidemiology of T. vaginalis infection rates.
CLINICAL ACTIONS:
Male: Urethritis| Epididymitis | Prostatitis
Women: Vaginal Discharge| Vulvar Irritation
Diagnostic testing for T. vaginalis should be performed in women seeking care for vaginal discharge (yellow-green, with or without irritation). Screening might be considered for women receiving care in high-prevalence settings.
Diagnosis
Perform nucleic acid amplification testing (NAAT), which detects T. vaginalis genetic material, is highly sensitive and which is three to five times more likely to identify T. vaginalis infections than wet-mount microscopy, a method with poor sensitivity
Culture was considered the gold standard before molecular testing and is less sensitive than newer tests
If wet preparations are used, despite lower sensitivities, slides should be evaluated immediately as sensitivity declines with time
If negative, consider follow up with a NAAT to make sure infection is truly not present
T. vaginalis may be an incidental finding on a Pap test, neither conventional nor liquid-based Pap tests are considered diagnostic tests for Trichomoniasis, because false negatives and false positives can occur
KEY POINTS:
The nitroimidazoles are the only class of antimicrobial medications known to be effective against T. vaginalis infections. Of these drugs, metronidazole and tinidazole have been cleared by FDA for the oral or parenteral treatment of trichomoniasis.
The CDC recommends the following
Women
Metronidazole 500 mg 2 times/day for 7 days
Men
Metronidazole 2 g orally in a single dose
Alternative regimen for men and women
Tinidazole 2 g orally in a single dose
Note: ACOG also recommends metronidazole 500 mg orally twice a day for 7 days as the recommended treatment option with tinidazole, 2 g orally in a single dose as the alternative regimen
Alcohol consumption should be avoided during treatment with nitroimidazoles
To reduce the possibility of a disulfiram-like reaction, abstinence from alcohol use should continue for 24 hours after completion of metronidazole or 72 hours after completion of tinidazole
Providers should advise persons infected with T. vaginalis to abstain from sex until they and their sex partners are treated (i.e., when therapy has been completed and any symptoms have resolved)
Testing for other STDs including HIV should be performed in persons infected with T. vaginalis
Retest for T. vaginalis is recommended for all sexually active women within 3 months following initial treatment
Testing by NAAT can be conducted as soon as 2 weeks after treatment
Treat current partners to avoid reinfection and further transmission
Partners should be advised to abstain from intercourse until they and their sex partners have been adequately treated and any symptoms have resolved
In States where legally allowed (see learn more below), consider Expedited Partner Therapy (EPT) which allows the patient herself to provide medications to her partner when there are limited public health services to treat a partner, or concern that the partner will not have access to treatment
Pregnancy
T. vaginalis infection is associated with two to threefold increased risk for HIV acquisition, preterm birth, and other adverse pregnancy outcomes among pregnant women
However, some trials have not shown improvement in perinatal morbidity with treatment
Symptomatic pregnant women, regardless of pregnancy stage, should be tested and considered for treatment with metronidazole
Tinidazole should be avoided for pregnant women
The benefit of routine screening for T. vaginalis in asymptomatic pregnant women has not been established
HIV
Among women with HIV infection, up to 53% are also infected with T. vaginalis which has been associated with an increased risk for PID
Routine screening of asymptomatic women with HIV infection for T. vaginalis is recommended on entry to care, and then annually
Pregnant women, including those who are asymptomatic, should be screened and treated as necessary because T. vaginalis infection is a risk factor for vertical HIV transmission
The recommended regimen in the setting of HIV is as follows
Annual screening for gonococcal infection (GC) (N. gonorrhoeae) is recommended for all sexually active women aged <25 years and for older women at increased risk for infection (e.g., those who have a new sex partner, more than one sex partner, a sex partner with concurrent partners, or a sex partner who has a sexually transmitted infection).
Diagnosis
Perform nucleic acid amplification testing (NAAT), which detects genetic material of N. gonorrhoeae
More sensitive than culture
Faster results than culture
Easy to obtain from a vaginal swab
Currently approved for genital (vaginal, endocervical) and urine samples
Can NOT determine antibiotic resistance
OR
Culture for N. gonorrhoeae
Requires endocervical swab, not vaginal
Available for rectal, oropharyngeal, and conjunctival gonococcal infection
NOTE:Obtain BOTH NAAT and culture in the case of treatment failure to determine bacterial susceptibility to antibiotics
SYNOPSIS:
Specific microbiologic diagnosis of infection with N. gonorrhoeae should be performed in all persons at risk for, or suspected to have, gonorrhea. A specific diagnosis can potentially reduce complications, reinfections, and transmission. The CDC no longer recommends combination therapy for uncomplicated GC
KEY POINTS:
For Uncomplicated Gonococcal Infections of the Cervix, Urethra and Rectum
<150 kg (300 lb): Ceftriaxone 500 mg IM as a single dose
≥150 kg (300 lb): 1 g of IM ceftriaxone
If chlamydial infection has not been excluded
Treat for chlamydia with doxycycline 100 mg orally twice daily for 7 days
During pregnancy, azithromycin 1 g as a single dose is recommended to treat chlamydia
If Ceftriaxone is Unavailable
Gentamicin 240 mg IM as a single dose plus azithromycin 2 g orally as a single dose or
Cefixime 800 mg orally as a single dose | If treating with cefixime, and chlamydial infection has not been excluded, providers should treat for chlamydia with doxycycline 100 mg orally twice daily for 7 days | During pregnancy, azithromycin 1 g as a single dose is recommended to treat chlamydia
Uncomplicated Gonococcal Infections of the Pharynx
<150 kg (300 lb): Ceftriaxone 500 mg IM as a single dose
≥150 kg (300 lb): 1 g of IM ceftriaxone
If chlamydial infection has not been excluded
Treat for chlamydia with doxycycline 100 mg orally twice daily for 7 days
During pregnancy, azithromycin 1 g as a single dose is recommended to treat chlamydia
Note: No reliable alternative treatments are available for pharyngeal gonorrhea
Additional Notes
Instruct patient to abstain from sexual activity for 7 days after treatment and until all sex partners are adequately treated (7 days after receiving treatment and resolution of symptoms, if present)
Test for other STIs, including chlamydia, syphilis and HIV
A test-of-cure is not needed for persons who receive a diagnosis of uncomplicated urogenital or rectal gonorrhea who are treated with any of the recommended or alternative regimens
In the case of pharyngeal gonorrhea treated with an alternative regimen, the patient should return 14 days after treatment for a test-of cure using either culture or NAAT
If NAAT positive, do a confirmatory culture and antimicrobial susceptibility testing
Retest after 3 months
Recurrence may not be treatment failure but rather reinfection
In States where legally allowed (see learn more below), consider Expedited Partner Therapy (EPT) which allows the patient herself to provide medications to her partner when there are limited public health services to treat a partner, or concern that the partner will not have access to treatment
Treat women with HIV with the same recommended regimen
Consult infectious disease specialist in case of allergies to cephalosporin
Chlamydia: CDC Recommendations for Diagnosis and Treatment
CLINICAL ACTIONS:
Annual screening of all sexually active women aged <25 years for chlamydia is recommended, as is screening of older women at increased risk for infection (e.g., those who have a new sex partner, more than one sex partner, a sex partner with concurrent partners, or a sex partner who has an STD).
To diagnose a chlamydia infection:
Obtain nucleic acid amplification testing (NAAT), which detects genetic material of C. trachomatis
Highly sensitive in first-catch urine samples and endocervical or vaginal swabs
Can be collected by a provider or a self-collected vaginal swab
Certain NAATs have been FDA-cleared for use on liquid-based cytology specimens (collected for Pap smears), however sensitivity may be lower than swabs
SYNOPSIS:
Chlamydial infection is the most frequently reported infectious disease in the United States, and prevalence is highest in persons aged ≤24 years. Several sequelae can result from C. trachomatis infection in women, the most serious of which include PID (pelvic inflammatory disease), ectopic pregnancy, and infertility. Some women who receive a diagnosis of uncomplicated cervical infection already have subclinical upper-reproductive–tract infection.
KEY POINTS:
Chlamydia treatment should be provided promptly for all persons testing positive for infection; treatment delays have been associated with complications
Recommended Regimens
Azithromycin 1 g orally in a single dose or
Doxycycline 100 mg orally twice a day for 7 days
Alternative Regimens
Erythromycin base 500 mg orally four times a day for 7 days or
Erythromycin ethylsuccinate 800 mg orally four times a day for 7 days or
Levofloxacin 500 mg orally once daily for 7 days or
Ofloxacin 300 mg orally twice a day for 7 days
Routine pharyngeal screening for chlamydia is not recommended, but if C. trachomatis is detected in an oropharyngeal specimen treat with azithromycin or doxycycline
Directly observe patient receiving therapy when single dose therapy is given
To minimize disease transmission to sex partners, persons treated for chlamydia should be instructed to abstain from sexual intercourse for 7 days after single-dose therapy or until completion of a 7-day regimen and resolution of symptoms if present
To minimize risk for reinfection, patients also should be instructed to abstain from sexual intercourse until all of their sex partners are treated
Persons who receive a diagnosis of chlamydia should be tested for HIV, gonococcal infection, and syphilis
Test-of-cure to detect therapeutic failure is not advised unless therapeutic adherence is in question, symptoms persist, or reinfection is suspected
Chlamydial NAATs at <3 weeks after completion of therapy is not recommended because the continued presence of nonviable organisms can lead to false-positive results
Retest after 3 months
Recurrence may not be treatment failure but rather reinfection
In States where legally allowed (see ‘Related OBG Topics’ below), consider Expedited Partner Therapy (EPT) which allows the patient herself to provide medications to her partner when there are limited public health services to treat a partner, or concern that the partner will not have access to treatment
Treat women with HIV with the same recommended regimen
PREGNANCY AND CHLAMYDIAL INFECTION
Risks in pregnancy include preterm labor, premature rupture of membranes and low birth weight with neonates at risk for conjunctivitis (ophthalmia neonatorum) and pneumonia. It is therefore imperative to screen and treat pregnant women with the following:
Recommended Regimens
Azithromycin 1 g orally in a single dose
Alternative Regimens
Amoxicillin 500 mg orally three times a day for 7 days or
Erythromycin base 500 mg orally four times a day for 7 days or
Erythromycin base 250 mg orally four times a day for 14 days or
Erythromycin ethylsuccinate 800 mg orally four times a day for 7 days or
Erythromycin ethylsuccinate 400 mg orally four times a day for 14 days
Test-of-cure (preferably by NAAT) recommended at 3 to 4 weeks after completion of therapy and again after 3 months
Diagnosis code: Chlamydia: A74.9 (pregnant) or A56.02 (nonpregnant)
Pregnant women are considered a ‘special population’ by the CDC. Due to the potential burden to pregnant women, offspring and partners, providers should ask all pregnant women and their partners about STIs, and ensure counseling, screening and treatment are available.
Rapid HIV testing should be performed on any woman in labor who has not been screened during pregnancy, unless she declines
If rapid HIV test positive, antiretroviral prophylaxis should be administered prior to receiving confirmatory test results
AAP recommends expedited HIV testing as soon as possible after birth for infants born to women with unknown HIV status
NOTE: The USPSTF (June 2019) continues to recommend screening for HIV infection in all pregnant persons, including those who present in labor or at delivery whose HIV status is unknown. (A recommendation)
SYPHILIS
Serologic tests should be performed at first prenatal visit
Screening for syphilis infection is a 2-step process | Antepartum screening can be performed by manual nontreponemal antibody testing (e.g., RPR) by using the traditional syphilis screening algorithm or by treponemal antibody testing (e.g., immunoassays)
Traditional screening: Initial “nontreponemal” antibody test (ie, Venereal Disease Research Laboratory test or rapid plasma reagin [RPR] test) to detect biomarkers released from damage caused by syphilis infection, followed by a confirmatory “treponemal” antibody detection test (ie, fluorescent treponemal antibody absorption [FTA-ABS] or T pallidum particle agglutination test [TP-PA])
Reverse sequence screening algorithm: Automated treponemal test (such as an enzyme-linked [EIA], chemiluminescence [CIA], or multiplex flow immunoassay [immunoblot]) performed first, followed by a nontreponemal test
If the test results of the reverse sequence algorithm are discordant, a second treponemal test (preferably using a different treponemal antibody) is performed
Pregnant women with positive treponemal screening tests (e.g., EIA, CIA, or immunoblot) should have additional quantitative nontreponemal testing because titers are essential for monitoring treatment response
If access to prenatal care is suboptimal, RPR test and treatment should be performed at time of pregnancy confirmation
Serologic retesting in the 3rd trimester (28 weeks) and at delivery if the patient for patients at high risk including
Sex with multiple partners | Sex in conjunction with drug use or transactional sex
Late entry to prenatal care (i.e., first visit during the second trimester or later) or no prenatal care
Methamphetamine or heroin use
Incarceration of the woman or her partner
Unstable housing or homelessness
Test any woman who delivers a stillborn or in the case of infant death
Untreated syphilis has a 40% infant death rate
Do NOT discharge neonate if serologic status is unknown
Newborn infection may not be immediately obvious
Within a few weeks may develop
Developmental delay
Seizures
Birth defects such as bone deformation, blindness and deafness
Note: In September 2018, the USPSTF reaffirmed previous guidance and “recommends early screening for syphilis infection in all pregnant women.” (Grade A – Offer or Provide this Service)
HEPATITIS B (HBV)
Screen during each pregnancy, preferably in the first trimester, regardless of vaccination status or history of testing
Use ‘triple panel’: Hepatitis B surface antigen (HBsAg), antibody to HBsAg, and total antibody to HBcAg (total anti-HBc)
If patient underwent appropriately timed triple panel screening and has not had any new HBV exposures since triple panel screening, only HBsAg screening is required
At time of admission for delivery, retest if patient
Is at high risk – more than one sex partner in previous 6 months, evaluation or treatment for STI, injection-drug use, HBsAG-positive sex partner
Was not screened prenatally
Has clinical hepatitis
Always do HBsAg testing prior to giving the HBV vaccine to avoid misinterpretation
Report HBsAg positive women to local or state health departments to ensure they are entered into a case management program to arrange access to appropriate vaccinations for contacts and prophylaxis for infants
If HBsAg positive, test for hepatitis B virus deoxyribonucleic acid (HBV DNA) to guide the use of antiviral medication to prevent perinatal transmission
If HBV DNA >200,000 IU/mL (7.6 log10 IU/mL): The American Association for the Study of Liver Diseases suggests antiviral therapy during pregnancy to further reduce perinatal HBV transmission
HEPATITIS C (HCV)
The CDC has updated HepC guidelines (2020)
Hepatitis C screening at least once in a lifetime for all adults aged ≥18 years, except in settings where the prevalence of HCV infection (HCV RNA-positivity) is <0.1%
Hepatitis C screening for all pregnant women during each pregnancy, except in settings where the prevalence of HCV infection (HCV RNA-positivity) is <0.1%
USPSTF also calls for universal screening for HCV infection, including pregnancy
Recommended Screening Tests for Pregnant Women at Risk
CHLAMYDIA
Test all pregnant women who are <25 years old for Chlamydia trachomatis at the first prenatal visit
Test all older women if at high risk:
More than one sex partner
A sex partner with concurrent partners or has an STI
Retest in the 3rd trimester to prevent maternal postnatal complications and chlamydia infection in the neonate
Test of cure by NAAT 3 to 4 weeks after treatment and retest within 3 months
GONORRHEA
Test all pregnant women who are <25 years old for N. gonorrhoeae at the first prenatal visit
Test all older women if at high risk:
More than one sex partner
A sex partner with concurrent partners or has an STI
Inconsistent condom use in non-monogamous relationships
Previous or co-existing sexually transmitted infections
Exchanging sex for money or drugs
Consider consulting local public health authorities for further guidance on identifying those at high risk related to geographic location
Treat all positive patients immediately and retest in 3 months
Retest in the 3rd trimester to prevent maternal postnatal complications and chlamydia infection in the neonate
HEPATITIS C (HCV)
The CDC has updated HepC guidelines (2020)
Hepatitis C screening at least once in a lifetime for all adults aged ≥18 years, except in settings where the prevalence of HCV infection (HCV RNA-positivity) is <0.1%
Hepatitis C screening for all pregnant women during each pregnancy, except in settings where the prevalence of HCV infection (HCV RNA-positivity) is <0.1%
USPSTF also calls for universal screening for HCV infection, including pregnancy
HEPATITIS C (HCV)
The CDC has updated HepC guidelines (2020)
Hepatitis C screening at least once in a lifetime for all adults aged ≥18 years, except in settings where the prevalence of HCV infection (HCV RNA-positivity) is <0.1%
Hepatitis C screening for all pregnant women during each pregnancy, except in settings where the prevalence of HCV infection (HCV RNA-positivity) is <0.1%
USPSTF also calls for universal screening for HCV infection, including pregnancy
Screen Only if Symptomatic
Bacterial Vaginosis (BV)
Evidence does not support routine screening
Evaluate and screen symptomatic women
The USPSTF addresses BV screening during pregnancy and states the following
The USPSTF addresses BV screening during pregnancy and states the following The USPSTF recommends against screening for bacterial vaginosis in pregnant persons not at increased risk for preterm delivery. (D recommendation)
The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for bacterial vaginosis in pregnant persons at increased risk for preterm delivery. (I statement)
Trichomonas
Evidence does not support routine screening
Evaluate and screen symptomatic women
HSV-2
Evidence does not support routine screening
In the absence of lesions during the 3rd trimester, routine cultures for HSV are not indicated for women in the 3rd trimester who have a history of recurrent genital herpes
Type-specific serologic tests may help identify pregnant women at risk for HSV and to help guide counseling regarding the risk of acquiring herpes during pregnancy
SYNOPSIS:
Recommendations for STI testing can vary based on certain considerations, including state laws. The CDC recommendations are considered broader, such that more women will potentially be screened, but are consistent with other CDC guidance with the intention of preventing adverse outcomes for pregnant women, partners and fetuses.
KEY POINTS:
All pregnant women and their partners should be asked about STIs and counseled regarding personal risks as well as pregnancy and outcomes
Pap Smears should be performed in pregnancy at the same frequency as nonpregnant women
Management of abnormal Pap tests differ in pregnancy
Screening at Delivery
SYPHILIS
Select groups of pregnant women, including women who are at high risk for syphilis or live in areas of high syphilis morbidity
Pregnant women with no previously established status
Pregnant women who deliver a stillborn infant
HIV
Pregnant women not screened during pregnancy
HBV
Women admitted for delivery at a health care facility without documentation of HBsAg test results should have blood drawn and tested as soon as possible after admission
Women at high risk
Having had more than one sex partner during the previous 6 months, an HBsAg-positive sex partner, evaluation or treatment for a sexually transmitted disease, or recent or current injection-drug use
Women with signs or symptoms of hepatitis
Note: CDC recommends universal hepatitis B vaccination within 24 hours of birth for medically stable infants >2000 grams
Permissive language that allowed the vaccine to be delayed until after hospital discharge has been removed
Administer hepatitis B vaccination and hepatitis immune globulin regardless of birth weight within 12 hours of birth for infants born to hepatitis b-infected mothers
CHLAMYDIA
Pregnant women less than 25 years of age
Continued high risk
New or multiple sex partners, sex partner with concurrent partners, sex partners who have a sexually transmitted disease
GONORRHEA
Continued high risk
Past or current injection-drug use, having had a blood transfusion before July 1992, receipt of an unregulated tattoo, having been on long-term hemodialysis, intranasal drug use, and other percutaneous exposures
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