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RAPID HIV/Syphilis Ab
Registration Number: № Г004−110−00/4 007 336
A lateral flow immunoassay for qualitative detection of total antibodies to HIV-½, including group O, and T. pallidum in serum, plasma and whole blood.
The Current Diagnostic Landscape
Global Strategy for Mother-to-Child Transmission (MTCT)
The World Health Organization (WHO) has set a strategic goal to eliminate the mother-to-child transmission of HIV and syphilis. A key requirement for success is expanding access to early, high-quality screening at the primary healthcare level and as a standard part of antenatal care (ANC).
The Burden of Maternal and Perinatal Health
WHO estimates that annually, 1.3 to 1.4 million women living with HIV become pregnant, while approximately 1 million pregnant women are infected with syphilis. These dual infections are major contributors to maternal and perinatal morbidity and mortality worldwide.
Syphilis and Perinatal Outcomes
Syphilis remains the second leading cause of stillbirth globally. Each year, more than 700,000 cases of congenital syphilis are reported, resulting in over 350,000 adverse birth outcomes, including more than 200,000 stillbirths and neonatal deaths.
The World Health Organization (WHO) has set a strategic goal to eliminate the mother-to-child transmission of HIV and syphilis. A key requirement for success is expanding access to early, high-quality screening at the primary healthcare level and as a standard part of antenatal care (ANC).
The Burden of Maternal and Perinatal Health
WHO estimates that annually, 1.3 to 1.4 million women living with HIV become pregnant, while approximately 1 million pregnant women are infected with syphilis. These dual infections are major contributors to maternal and perinatal morbidity and mortality worldwide.
Syphilis and Perinatal Outcomes
Syphilis remains the second leading cause of stillbirth globally. Each year, more than 700,000 cases of congenital syphilis are reported, resulting in over 350,000 adverse birth outcomes, including more than 200,000 stillbirths and neonatal deaths.
Clinical Impact & Benefits:
01
Early Antenatal Screening
Aligned with WHO recommendations, the test ensures all pregnant women are screened for both HIV and syphilis, ideally during the first trimester to maximize intervention efficacy.
02
Mitigating Congenital Risks
Rapid testing minimizes the time to diagnosis, allowing for the immediate initiation of therapy. This critical response significantly reduces the risk of mother-to-child transmission (MTCT) and prevents adverse pregnancy outcomes.
Key Advantages
Optimized for emergency screening and rapid diagnostic results in urgent clinical situations.
Requires no specialized laboratory equipment or complex infrastructure.
Significantly lower cost compared to standard laboratory-based screening methods.
Ensures diagnostic coverage in remote and hard-to-reach geographical regions.
Technical Specifications
Time to Result:
8 minutes
Reproducibility:
100%
Limit of Detection (LOD):
HIV-½: 1/500 dilution
T. pallidum: 1/100 dilution
T. pallidum: 1/100 dilution
Interpretation
NEGATIVE RESULT
Appearance in the test window of only the control line “C”. Staining of the test line “T” does not occur.
Positive result
Appearance in the test window of two colored lines: the control line “C” and the test line “T”.
The color intensity of the test line may vary.
The color intensity of the test line may vary.
Invalid result
In the test window, the control line “C” does not appear regardless of the presence of the test line “T”.
The cause of an invalid result may be incorrect performance of the analysis procedure or unsuitability of the medical device. In this case, it is recommended to repeat the testing procedure.
The cause of an invalid result may be incorrect performance of the analysis procedure or unsuitability of the medical device. In this case, it is recommended to repeat the testing procedure.
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