Test Description

Test Description

(1) Chlamydia and Gonorrhea (CLAM/GON)

SIGNS and SYMPTOMS

Symptoms will depend on the site of infection (e.g., oropharynx, urethra, cervix, rectum). Symptoms are not present in many patients, thus it is important to screen all patients at risk of STDs.

Symptoms will depend on the site of infection (e.g., oropharynx, urethra, cervix, rectum). Symptoms are not present in many patients, thus it is important to screen all patients at risk of STDs.

If symptoms are present, women may notice the following (depending on site of infection):

  • Vaginal discharge
  • Pain with sexual intercourse
  • Pain or burning on urination
  • Abdominal or pelvic pain
  • Sore throat
  • Rectal discharge
  • Anal discomfort or tenesmus

If symptoms are present, men may notice the following (depending on site of infection):

  • Pain or burning on urination
  • Urethral discharge
  • Testicular tenderness or pain
  • Sore throat
  • Rectal discharge
  • Anal discomfort

This test was performed using the BD ProbeTec™ Chlamydia trachomatis andNeisseria gonorrhoeae Amplified DNA Assays.

This test was performed using the BD ProbeTec™ Chlamydia trachomatis andNeisseria gonorrhoeae Amplified DNA Assays.

Clinical Significance

C. trachomatis infections are the leading cause of sexually transmitted diseases in the United States. C. trachomatis is known to cause cervicitis, Pelvic Inflammatory Disease (PID), infant conjunctivitis, infant pneumonia, urethritis, epididymitis and proctitis. It is also the most frequent cause of non-gonococcal urethritis in men. Among women, the consequences of chlamydial infections are severe if left untreated. Approximately half of chlamydial infections are asymptomatic.

Neisseria gonorrhoeae (gonococci) is the causative agent of gonorrhea. In men, this disease generally results in anterior urethritis accompanied by purulent exudate. In women, the disease is most often found in the cervix, but the vagina and uterus may also be infected.

(2) Hepatitis C (HEP C)

SIGNS and SYMPTOMS

Hepatitis C infection usually produces no signs or symptoms during its earliest stages. When signs and symptoms do occur, they may include:

  • Fatigue
  • Fever
  • Nausea or poor appetite
  • Muscle and joint pains
  • Yellowing of the skin and whites of the eyes (jaundice)

Methodology
Immunoassay (IA)

Limitations
Results obtained from immunosuppressed patients should be interpreted with caution. Patients receiving mouse antibody therapy may produce false-negative results.

Clinical Significance
Hepatitis C Virus (HCV) is the major cause of hepatitis. Approximately 1% of blood donors are seropositive for anti-HCV. The clinical symptoms of a HCV infection are variable. Exposure to HCV results in a chronic infection in 50 to 80% of cases. The “window” between infection and seroreactivity is highly variable, up to 12 months.

(3) HSV 1/2 IGG, HERPESELECT TYPE SPECIFIC AB (HERP 1/2)

Signs and Symptoms
Most individuals infected with HSV-1 or HSV-2 experience either no symptoms or have very mild symptoms that go unnoticed or are mistaken for another skin condition. Because of this, most people infected with HSV-2 are not aware of their infection. When symptoms do occur, they typically appear as one or more blisters on or around the genitals, rectum or mouth. The blisters break and leave painful sores that may take two to four weeks to heal. Experiencing these symptoms is sometimes referred to as having an “outbreak.” The first time someone has an outbreak they may also experience flu-like symptoms such as fever, body aches and swollen glands.

Repeat outbreaks of genital herpes are common, in particular during the first year of infection. Symptoms of repeat outbreaks are typically shorter in duration and less severe than the first outbreak of genital herpes. Although the infection can stay in the body indefinitely, the number of outbreaks tends to decrease over a period of years.
Methodology

Immunoassay (IA)
Limitations

Individuals infected with HSV may not exhibit detectable IgG antibody in the early stages of infection.

Clinical Significance
Herpes Simplex Virus (HSV) is responsible for several clinically significant human viral diseases, with severity ranging from inapparent to fatal. Clinical manifestations include genital tract infections, neonatal herpes, meningoencephalitis, keratoconjunctivitis, and gingivostomatitis. There are two HSV serotypes that are closely related antigenically. HSV type 2 is more commonly associated with genital tract and neonatal infections, while HSV type 1 is more commonly associated with infections of non-genital sites. Specific typing is not usually required for diagnosis or treatment. The mean time to seroconversion using the type specific assay is 25 days. The performance of this assay has not been established for use in a pediatric population, for neonatal screening, or for testing of immunocompromised patients.

(4) RPR (MONITOR) W/REFLEX TO TITER (SYPH)

SIGNS and SYMPTOMS

Primary stage

During the primary stage of syphilis, a sore (chancre) that is usually painless develops at the site where the bacteria entered the body. This commonly occurs within 3 weeks of exposure but can range from 10 to 90 days. A person is highly contagious during the primary stage.

  • In men, a chancre often appears in the genital area, usually (but not always) on the penis. These sores are often painless.
  • In women, chancres can develop on the outer genitals or on the inner part of the vagina. A chancre may go unnoticed if it occurs inside the vagina or at the opening to the uterus (cervix). The sores are usually painless and are not easily seen.
  • Swelling of the lymph nodes may occur near the area of the chancre.
  • A chancre may also occur in an area of the body other than the genitals.
  • The chancre usually lasts for 3 to 6 weeks, heals without treatment, and may leave a thin scar. But even though the chancre has healed, syphilis is still present and a person can still pass the infection to others.1

Secondary stage

Secondary syphilis is characterized by a rash that appears 2 to 8 weeks after the chancre develops and sometimes before it heals. Other symptoms may also occur, which means that the infection has spread throughout the body. A person is highly contagious during the secondary stage.

A rash often develops over the body and commonly includes the palms of the hands and the soles of the feet.

  • The rash usually consists of reddish brown, small, solid, flat or raised skin sores that are less than 2 cm (0.8 in.) across. But the rash may look like other more common skin problems.
  • Small, open sores may be present on mucous membranes. The sores may contain pus. Or moist sores that look like warts (called condyloma lata) may be present.
  • In dark-skinned people, the sores may be a lighter color than the surrounding skin.

The skin rash usually heals within 2 months. on its own without scarring. After healing, skin discoloration may occur. But even though the skin rash has healed, syphilis is still present and a person can still pass the infection to others.

When syphilis has spread throughout the body, the person may have:

  • A fever of usually less than 101°F (38.3°C).
  • sore throat.
  • A vague feeling of weakness or discomfort throughout the body.
  • Weight loss.
  • Patchy hair loss, especially in the eyebrows, eyelashes, and scalp hair.
  • Swelling of the lymph nodes.
  • Nervous system symptoms of secondary syphilis, which can include neck stiffness, headaches, irritability, paralysis, unequal reflexes, and irregular pupils.

Methodology
Flocculation

Limitations
False-positive results have been associated in patients with infections, pregnancy, autoimmune disease, old age, Gaucher disease, and malignancy.

Clinical Significance
This is a non-treponemal screening test for syphilis. False positive results may occur due to systemic lupus erythematosus, leprosy, brucellosis, atypical pneumonia, typhus, yaws, pinta, or pregnancy. Monitoring of RPR is helpful in assessing effectiveness of therapy.

Test Description– This 4th generation HIV Ag/Ab Combo assay is intended to be used as an aid in the diagnosis of HIV1/HIV2 infection, including acute or primary HIV-1 infection.

Fourth-generation assays have >99.7% sensitivity and >99.3% specificity for HIV infection and can identify most (>80%) acute infections that would otherwise require nucleic acid testing for detection. In general, they can detect infection 0 to 20 days (median, 5-7 days) before third-generation immunoassays.