|Year : 2022 | Volume
| Issue : 2 | Page : 190-195
Syphilis reactivity in blood donors and their response rate – A study from 'Westernized” Western India and the need of the hour for a structured screening methodology
Merline Augustine1, Ankita Mahambare1, MV Mallya1, Maria Jose Wiseman Pinto2
1 Blood Center, Goa Medical College, Bambolim, Goa, India
2 Department of Microbiology, Goa Medical College, Bambolim, Goa, India
|Date of Submission||22-Jun-2022|
|Date of Decision||15-Jul-2022|
|Date of Acceptance||27-Aug-2022|
|Date of Web Publication||5-Nov-2022|
Blood Center, Goa Medical College, Bambolim, Goa
Source of Support: None, Conflict of Interest: None
Background and Objectives: An increasing prevalence of sexually transmitted infections especially Syphilis in blood donors may lead to increased donor deferrals and lessen the donor pool. Hence it is the need of the hour to device a structured screening methodology for Syphilis reactive donors. The aim of the study is to estimate the prevalence of syphilis in blood donors and to estimate the response rate of notified blood donors. Patients and Methods: This was a retrospective study, conducted in a Blood Centre (BC) on the blood donors visiting for donation from January 2020 to September 2021. The donors screened positive on chemiluminescence immunoassay were included after informed consent was obtained, and donor demographics and follow-up response rate were analyzed. Frequency and percentages were used to express descriptive statistics and Chi-square was used to test the relationship between categories( p<0.05 considered significant). Results: Out of 26,698 donations during the study period, 133 donors were screened positive for syphilis. 127 (96%) donors consented to postdonation. Out of 127, only 61 were notified regarding the infection and were advised about further followup. 52% of the donors who consented to postdonation counseling were not notified due to erroneous contact details. Out of 46 responders, only 17 underwent further testing. Conclusions: The prevalence rate of syphilis was found to be 0.49%. Among the donors notified, 75% responded back to the BC. Due to social stigma and inadequate knowledge about the disease, often, donors are hesitant to give a reliable exposure history. Adequate education and adapting to a structured screening methodology is the need of the hour to reduce the risk of transfusion-transmitted syphilis.
Keywords: Blood donation, blood donors, counseling, sexually transmitted diseases, syphilis, Treponema pallidum
|How to cite this article:|
Augustine M, Mahambare A, Mallya M V, Wiseman Pinto MJ. Syphilis reactivity in blood donors and their response rate – A study from 'Westernized” Western India and the need of the hour for a structured screening methodology. Glob J Transfus Med 2022;7:190-5
|How to cite this URL:|
Augustine M, Mahambare A, Mallya M V, Wiseman Pinto MJ. Syphilis reactivity in blood donors and their response rate – A study from 'Westernized” Western India and the need of the hour for a structured screening methodology. Glob J Transfus Med [serial online] 2022 [cited 2022 Dec 8];7:190-5. Available from: https://www.gjtmonline.com/text.asp?2022/7/2/190/360486
| Introduction|| |
Syphilis, a bygone disease caused by Treponema pallidum (TP), continues to be a worldwide public health problem with seven million new cases reported each year, as estimated by the World Health Organization (WHO) in 2020. There is a changing trend of reporting high-risk behavior among blood donors as reported in studies from India.,
Syphilis is transmitted by sexual mode, vertical, or from blood and blood components from an infective blood donor. TP are sensitive to cold temperatures, and hence, the rates of transmission through blood stored below 20°C for more than 72 h is minimal. In 1915, the first case of transfusion-transmitted syphilis was reported, and most cases were transmitted by donors in primary or secondary stages.,
The current diagnostic criteria based on serological methods include non-T pallidum serum tests namely venereal diseases research laboratory (VDRL) test, the rapid plasma reagin test (RPR), toluidine red unheated serum test, as well as the TP serum tests such as TP hemagglutination test (TPHA), micro-hemagglutination assay for TP, TP passive particle agglutination test, fluorescent treponemal antibody absorption test, enzyme immunoassay assay (EIA), and chemiluminescence immunoassay (CLIA). RPR is used in most of the blood centers (BCs) in India; however, due to automation, ease of operation, and ability to detect latent syphilis, TP serum tests such as EIA and CLIA are increasingly used in many BC.
National Blood Policy “An Action Plan for Blood Safety” adopted by the Government of India has recommended that blood donors be notified about their results if reactive. It is necessary to obtain consent from all blood donors during predonation screening for transfusion-transmitted infections (TTIs) testing and to notify if the results are reactive. Postnotification, the donors are permanently deferred and are referred to the specialty clinic for further investigations and treatment.
As most of the donors feel distressed about the notification calls made by BC, many of them do not follow-up or continue to donate blood elsewhere. Hence, the notification of reactive blood donors has become a challenging task for the staff involved with counseling.
With adoption of higher sensitive tests such as EIA and CLIA in BCs, the transmission of TTI is reduced. As per the latest Indian Drugs and Cosmetics act 2020 (D and C 2020) the donors who are tested reactive are permanently deferred. This can lead to a decrease in donor pool and future donations. Recently, the US Food and Drugs Administration (FDA) has recommended that the donors who are screened positive may re-enter donation after necessary investigations and treatment thereafter.
Aims and objectives
The aim of the study is to estimate the syphilis reactivity amongst blood donors visiting BC in a tertiary care hospital in Western India and to estimate the response rate of donors following notification of the reactive status.
| Methods|| |
A retrospective descriptive study was done on whole blood donors, found medically fit for blood donation, reporting to a BC in Western India from January 2020 to September 2021. The study was conducted in the only tertiary care center in the touristic and westernized state of India. Written informed consent was obtained from the donors before donation and the donors who did not consent were excluded. All donors underwent predonation screening and medical examination before the blood donation in accordance with the D and C Act 2020. Postdonation counseling was offered to all the donors.
Testing of donor samples
The donor samples were tested for TTI using chemiluminiscence microparticle immunoassay by ABBOTT ARCHITECT i1000sr (manufactured by Abbott Diagnostics Inc., US) for HIV, HBV, HCV, and syphilis as per the department standard operating procedure (SOP). The ARCHITECT syphilis TP assay is a qualitative immunoassay that detects IgG and IgM antibodies to TP in the human serum or plasma. The reactivity of the donor sample is determined by the chemiluminescent signal which would be equal or greater than the cutoff (CO) signal from previous ARCHITECT TP calibration. The ARCHITECT system calculates the CO using mean chemiluminescent signal (RLU) from three replicates of the calibrator. CO = calibrator RLU × 0.20. Once the sample is run, sample RLU/CO is calculated. Any value <1.00 is considered nonreactive and >1.00 is considered reactive by the ARCHITECT Syphilis TP assay.
Donor notification and counseling
The blood units tested reactive were discarded according to the BC SOPs. Donors tested reactive by CLIA for syphilis were telephonically contacted by the BC medical social worker (MSW) from the contact details provided at the time of predonation screening, within the first 15 days from the date of testing. They were informed to visit BC for postdonation counseling within 1 week following the telephonic call from the BC. Reattempts are made at least three times, every week before the case is labeled as nonresponder and the rest as responders.
The responders were counseled about further tests and treatment options and were all advised for permanent deferral from blood donations.
Referral and further testing
The referred donors were examined by the specialty doctor and were advised for testing by two methods; TPHA and VDRL. It was performed in the Department of Microbiology where TPHA and VDRL were performed on the fresh blood sample of the donor.
VDRL test was performed using TREPOLIPIN reagent (Tulip Diagnostics Pvt. Limited). It is a quantitative (dilutions) as well as qualitative test performed on serum, plasma. as well as cerebrospinal fluid. The presence of flocculation denotes a sample reactive indicating the presence of antilipoidal antibodies.
TPHA was performed using SYPHICHECK-WB (Zephyr Biomedicals, a product of Tulip Diagnostics Pvt. Limited) which is a qualitative rapid sandwich immunoassay that detects anti-TP IgG and IgM antibodies in the serum/plasma or whole blood.
Posttesting counseling and treatment
Following testing, if any of the test results are positive, the donors were treated by hospital policies along with sequential titer evaluation of VDRL till negative [Figure 1].
Data collection and statistical analysis
All the data were retrieved from the departmental records and patient follow-up registers. The data were entered in Microsoft excel and was analyzed using SPSS version 23 (IBM SPSS Statistics for Windows, Version 23.0. released 2015. Armonk, NY: IBM Corp). Categorical data were represented in the form of frequencies and percentages. Continuous data were represented as median and range. Chi-square test was done to estimate the level of significance.
Ethical clearance for the study was obtained from the institutional ethical board.
| Results|| |
A total of 26,698 donations were collected during the study period. Out of 26,698, 344 (1.2%) donations were discarded due to positive screening of TTI.
Among the TTI seroreactive donations (n = 344), 133 donations (38%) were screened positive for syphilis by CLIA. The period prevalence of syphilis is 0.49%. Out of 133, majority 86% (114) were male. Median age was 37 (18–61) years; most of the donors were in the age group of 21–39 years (56%). Majority of the donors were replacement donors 76 (57%). The demographic details are given in [Table 1].
Among the donors with positive screen for syphilis, 127 (96%) had consented to postdonation counseling if tested positive and six (4%) had not consented. None gave high-risk exposure history during predonation counseling. The donors who had consented to postdonation counseling, 61 (48%), were notified by the contact details given and the rest (52%) were not traced as the contact details given were not reachable or inaccurate. The traced donors were subsequently called to the BC for follow-up, but only 46 (75%) of them responded and rest 15 (25%) did not [Figure 2]. The demographic comparison of responders and nonresponders [Table 2] showed no significant difference. Only 17 (37%) of 46 donors followed up for further testing, and among them, ten (59%) had tested positive for at least one of the tests, i.e., TPHA or VDRL. Positive TPHA or VDRL was given a course of sensitive antibiotics [Figure 1]. Seven donors (41%) were tested negative for both of the tests but did not follow-up with BC with the reports.
| Discussion|| |
Recent data by the WHO have shown an upsurge in sexually transmitted diseases (STDs) with approximately 374 million people infected with one of the four STDs; Chlamydia, gonorrhea, syphilis, and trichomoniasis; syphilis crossing over 7 million cases each year. A rising trend of STDs is also reflected in studies conducted in India., The alteration in the pattern of STDs may be related to modernization of the society which in turn is related to migration of young population across places for work, influence of new culture on beliefs about sexuality, and hence participation in high-risk sexual behaviors. Blood donation safety and a rising trend of STDs are inversely related. Recent advances in screening of blood through advanced methods such as nucleic acid testing and immunoassays (CLIA, EIA) have led to early detection of infectious donors, but the complete elimination of such risk cannot be ruled out due to the chances of such donors being in “window period.”
The present study has reported a prevalence of 0.49% by CLIA. The results are comparable to the study done by Yadav et al. and Mandal et al. where nontreponemal tests (VDRL, RPR) have been used for screening compared to the present study., A higher prevalence of syphilis is reported at 0.95% and 1.17% compared to the present study using CLIA on blood donors., These studies have shown that treponemal-specific tests such as CLIA and EIA can help detecting even latent cases of syphilis at the cost of increased false reactive. D and C Act 2020, followed in all BCs in India, has not specified any screening method but advises permanent deferral of the reactive donors.
The study was conducted in a South Western coastal State of India known for its tourism and comparatively “westernized” than other parts of India. Most of the cases reported in our study were male donors and were in the age group of 21–39 years. Overall lesser number of donors in extremes of age and more female donors getting deferred in predonation medical checkup due to lower hemoglobin may be attributed to this distribution of reactive donors.
The majority of the reactive donors donated blood as the replacement donors as seen similar to other studies., Being answerable and feeling responsible for the patient for whom the intended donation was to be done, and also paid donors enacting as known replacement donors can be the reasons compelling the replacement donors to donate despite being known about the fallouts of the donation. Hence, replacement donations are less suitable and should be discouraged.
No donors who were tested reactive for syphilis screening gave any history of high-risk behavior as seen similar in other studies as well and only disclosed their sexual habits once counseled and questioned during postdonation counseling., Most of the donors were professionals indicating that most were educated but failed to disclose any high-risk behavior. The donors in the present study were mostly repeated donors, indicating that most the donors were aware of the donor history questionnaire (DHQ) and in spite of continued donation. Fear of disclosure and hesitation to answer to the DHQ on one-to-one basis to the MSW can be one of the reasons for noncompliance. More effective ways such as computer-assisted structured interviews (CASI) and hence self-deferral can be helpful in reducing donation of reactive blood units.
The study has revealed 75% response rate (46 out of 61) of donors following notification of reactive syphilis screen, which is similar to a study done by Patel et al. from Western India with a response rate of 63%. This result was superior to another study done in Northern India where the response rate was a mere 19.8% in syphilis-reactive donors. Our study had shown better response rate; however, 52% (n = 66) donors were not notified out of 127 donors who consented for postdonation counseling of reactive status. This was due to multiple reasons such as inaccurate contact details and phone being switched off to name a few of them. Donor traceability continues to be an important issue as it is difficult to assess the reliability of the information provided by the donor. There are various identification cards (Aadhar card, driving license, ID card provided by employee, etc.) each bearing a different residential address if not updated while moving to a new place of residence. Hence, traceability will be of great challenge if residential address is used to track the donors. Traceability by contact numbers is another hurdle as, most of the times, donors provide inaccurate contact details. One way to prevent it is by registering the donor while predonation counseling with his contact details and confirming the same with an automated text message to the contact number (e.g., “You are now registered with xxx BC as a voluntary blood donor and XXXXX is your registration ID”). The registration ID can be a unique ID for each donor and each time donor visits BC for donation, the last donation date/results of screening may be rechecked by the counselor to confirm the same. This will help reduce malpractice among donors. Among the responders, i.e., out of 46, only 17 performed further testing. Seven of 17 were negative with further testing, and rest ten who were tested positive with either one of the tests had completed their course of treatment with sensitive antibiotics. The tests used in BC are screening tests and require further confirmatory tests to verify the diagnosis. The procedure of referral to specialty clinics from BC is rather a tedious process for the reason being the only tertiary care center and long awaiting queue of patients. The referred donors to save time either do not consult at all or consult nongovernment clinics and never return back with test results. This can be prevented if all the referred donors could be directed to a specialist clinician who only consults the blood donors and not combined consultation of all patients and donors together in same clinic for the convenience of donors.
To ensure transfusion safety and reduce the donor deferrals and hence blood donations, some effective measures must be taken by BC during predonation screening for example including direct questions such as exposure and the number of sexual partners. CASI can be helpful in societies where sexual habits are considered a taboo. Public awareness through posters, sign boards, and handouts of educational material in the donor screening rooms can help increase the rates of self-deferrals of donors in high-risk groups. Once tested reactive by screening method, donors should be adequately counseled, contacted, and convinced to undergo further testing and treatment so reduce further spread of the infection in the community.
With the drastic change in sexual beliefs and habits in the young blood donors, there is a changing trend of rising cases of syphilis in India. Advancement of technology for early detection like CLIA can lead to a higher detection rate at the cost of increase in number of false reactive in high prevalent areas. Although US FDA in its recent guidance updated in December 2020 allows re-entry of reactive syphilis donors after adequate treatment, D and C Act 2020 followed in BCs in India has mentioned that reactive syphilis donors to be permanently deferred., Reasons such as lack of a structured methodology in screening of syphilis in BCs in India and ongoing debate so as to whether treponemal or nontreponemal test can detect syphilis earlier have always been hindering the decision to choose a specific screening test. The authors recommend the application of screening tests based on the disease prevalence in the area as mentioned by the WHO. The present guidelines shall be adhered to till a revised and uniform methodology for screening blood donors in India for syphilis is released.
| Conclusion|| |
Our study has shown a prevalence of 0.49% reactive for syphilis in blood donors which is higher as compared to studies conducted earlier but similar to a study done by Kaur et al. This may be attributed to the changing sexual practices influenced by so-called “westernization of the society” and also due to the use of sensitive tests such as CLIA. Most of these young blood donors responded to the notification (75%), but a relevant percentage of the donors (52%) were not notified. These donors can pose a threat in further spreading the infection to others in the community and hence can gravely affect the blood inventory. Ample education regarding STDs via public talks and social media platforms should be encouraged. It is a need of the hour to uniformly adapt to a methodology for screening syphilis in Indian blood donors.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2]
[Table 1], [Table 2]