VALIDITY OF NEW RAPID TEST FOR HCV IN SALIVA AS A ROUTINE ANTENATAL INVESTIGATION
Mohamed Salah Abd Elhamid;
Abstract
The OraQuick® HCV test was FDA approved in February, 2011. It has come to wide commercial use thereafter. NICE guidelines advocated the use of the OraQuick HCV test as it detectsantibodies against hepatitis C virus and can be used on oral fluid, finger stick blood, venous blood, plasma or serum, giving results in 20–40 minutes. Eleven published studies showed that the OraQuick HCV has very high sensitivity and specificity.
What is new in the current study is the use of the same principal during pregnancy. The HCV status of a woman ought to be known before she enters the labor ward. This has many reasons, not the least important of which is the safety of the health care providers. We hereby issued this subject to validate the use of this well known test during pregnancy and opens new horizons for routine HCV screening for pregnant Egyptian ladies.
The aim of this study was to validate a new rapid non-invasive test (OraQuick) for detection of HCV infection in saliva of pregnant women with known and unknown anti-HCV antibody status.
This cross sectional study was conducted in antenatal care clinic at Ain Shams University Maternity Hospital from June 2014 to December 2015. It included two hundred pregnant women patients with unknown anti-HCV antibody status, to define sensitivity and specificity of a new non-invasive test for HCV in saliva in diagnosis of HCV infection in pregnant women. All participants were in their first pregnancy 90 cases (4.5%), 91 cases multigravida (95.5%) table (10) with age between 21-42 years old table (6).
After consenting to participate in the current study, demographic and physical data were enquired. Thorough history taking and physical examinations were performed. A salivary swab was taken and analyzed using the OraQuick® HCV Rapid Antibody Test. The results were compared to the results of blood samples obtained from the same population and analyzed by ELIZA and confirmed by PCR. The OraQuick® HCV Rapid Antibody Test is a single-use, anti-HCV assay. It is an immunoassay for the qualitative detection of immunoglobin G (IgG) antibodies to hepatitis C virus (anti-HCV) in oral fluid, fingerstick whole blood, plasma.
One hundred women gave a history of having diabetes mellitus constituting about fifty percent of our sample (table 8). This figure is quite large and was striking to the investigators. This can be explained by that most of the women attending for antenatal care have various medical disorders, as usually healthy women do not show up; 83 women of them were referred from other doctors and 47 women were referred as diabetic cases. Regular antenatal care is not yet a routine for every woman in Egypt. Also most cases enrolled in this study were multiparous women having higher incidence of DM in them must be much higher than in primigravidae. Only fourteen women were well known to be hypertensive, which is also much accepted and expected in the above context (table 8).
Almost ninety percent of the cases of the study had been affirmed to be subjected to past surgery. Again, this figure is expected; it can be explained by a couple of factors. First, as we were searching for a risk factor for HCV infection, we took any form of surgery as positive history including any dental operations and other minor surgical procedures. No matter what the magnitude of surgery was, whether general or local anesthesia was needed or not was not of importance to us. Even a very minor procedure was considered positive as it might have been the cause of HCV infection. Second, as we are dealing with a group of multipara, a large amount of them have already been delivered by cesarean section (80 cases), 153 cases out of 191 multigravidae had past history of episiotomy which of course was counted as a surgery. May be due to this concept that the past history of surgery was prevalent in both HCV positive and negative population and hence no statistical significance was yielded when comparing both groups as regard surgical history (table 9).
Clinical signs and symptoms of hepatitis C virus (HCV) infection are generally nonspecific, and many patients with acute or chronic infection are asymptomatic. As a result, laboratory testing for evidence of HCV infection is required for diagnosis. Because of its high sensitivity, ease of automation, and relatively low cost, enzyme immunoassay (EIA) for the detection of the IgG class of antibodies to HCV (IgG anti-HCV) is the most commonly used approach to HCV infection screening. Generally, EIA requires a subsequent patient encounter to provide results. This delay can lead to patient anxiety or loss to follow-up.
What is new in the current study is the use of the same principal during pregnancy. The HCV status of a woman ought to be known before she enters the labor ward. This has many reasons, not the least important of which is the safety of the health care providers. We hereby issued this subject to validate the use of this well known test during pregnancy and opens new horizons for routine HCV screening for pregnant Egyptian ladies.
The aim of this study was to validate a new rapid non-invasive test (OraQuick) for detection of HCV infection in saliva of pregnant women with known and unknown anti-HCV antibody status.
This cross sectional study was conducted in antenatal care clinic at Ain Shams University Maternity Hospital from June 2014 to December 2015. It included two hundred pregnant women patients with unknown anti-HCV antibody status, to define sensitivity and specificity of a new non-invasive test for HCV in saliva in diagnosis of HCV infection in pregnant women. All participants were in their first pregnancy 90 cases (4.5%), 91 cases multigravida (95.5%) table (10) with age between 21-42 years old table (6).
After consenting to participate in the current study, demographic and physical data were enquired. Thorough history taking and physical examinations were performed. A salivary swab was taken and analyzed using the OraQuick® HCV Rapid Antibody Test. The results were compared to the results of blood samples obtained from the same population and analyzed by ELIZA and confirmed by PCR. The OraQuick® HCV Rapid Antibody Test is a single-use, anti-HCV assay. It is an immunoassay for the qualitative detection of immunoglobin G (IgG) antibodies to hepatitis C virus (anti-HCV) in oral fluid, fingerstick whole blood, plasma.
One hundred women gave a history of having diabetes mellitus constituting about fifty percent of our sample (table 8). This figure is quite large and was striking to the investigators. This can be explained by that most of the women attending for antenatal care have various medical disorders, as usually healthy women do not show up; 83 women of them were referred from other doctors and 47 women were referred as diabetic cases. Regular antenatal care is not yet a routine for every woman in Egypt. Also most cases enrolled in this study were multiparous women having higher incidence of DM in them must be much higher than in primigravidae. Only fourteen women were well known to be hypertensive, which is also much accepted and expected in the above context (table 8).
Almost ninety percent of the cases of the study had been affirmed to be subjected to past surgery. Again, this figure is expected; it can be explained by a couple of factors. First, as we were searching for a risk factor for HCV infection, we took any form of surgery as positive history including any dental operations and other minor surgical procedures. No matter what the magnitude of surgery was, whether general or local anesthesia was needed or not was not of importance to us. Even a very minor procedure was considered positive as it might have been the cause of HCV infection. Second, as we are dealing with a group of multipara, a large amount of them have already been delivered by cesarean section (80 cases), 153 cases out of 191 multigravidae had past history of episiotomy which of course was counted as a surgery. May be due to this concept that the past history of surgery was prevalent in both HCV positive and negative population and hence no statistical significance was yielded when comparing both groups as regard surgical history (table 9).
Clinical signs and symptoms of hepatitis C virus (HCV) infection are generally nonspecific, and many patients with acute or chronic infection are asymptomatic. As a result, laboratory testing for evidence of HCV infection is required for diagnosis. Because of its high sensitivity, ease of automation, and relatively low cost, enzyme immunoassay (EIA) for the detection of the IgG class of antibodies to HCV (IgG anti-HCV) is the most commonly used approach to HCV infection screening. Generally, EIA requires a subsequent patient encounter to provide results. This delay can lead to patient anxiety or loss to follow-up.
Other data
| Title | VALIDITY OF NEW RAPID TEST FOR HCV IN SALIVA AS A ROUTINE ANTENATAL INVESTIGATION | Other Titles | قياس كفاءة الاختبار السريع الجديد للعاب فى تشخيص الفيروس الكبدى سى فى الحوامل | Authors | Mohamed Salah Abd Elhamid | Issue Date | 2017 |
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