Evaluation of Cortez OneStep Chlamydia Rapicard™ Insta Test for the Detection of Chlamydia trachomatis in Pregnant Women at Mbare Polyclinic in Harare, Zimbabwe.

Stephen Stephen, Msc,Chiwoneso Gwyneth Elizabeth Muchaneta-Kubara, Phd,Marshall Wesley Munjoma, Phd,Gibson Mandozana, Phd

doi:10.21106/ijma.150

Stephen Stephen, Msc, Chiwoneso Gwyneth Elizabeth Muchaneta-Kubara, Phd + Show 2 more

Open Access

https://doi.org/10.21106/ijma.150

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Abstract

Background:Cervical chlamydia infection poses high risk of pregnancy complications and neonatal infection. Reference methods for the detection of chlamydia infection are not available for routine use in developing countries. Point-of-care (POC) tests can bridge this gap. This study evaluated Cortez Onestep Chlamydia Rapicard™ insta test for the detection of Chlamydia trachomatis in pregnant women at Mbare Polyclinic and determined the prevalence of C. trachomatis.Methods:This was a cross sectional study in 242 pregnant women aged ≥18 years attending their first ANC visit at Mbare polyclinic in Harare, Zimbabwe. Data collection form was used to obtain demographic and predisposing factors to Chlamydia infection and two endocervical swabs were collected from each patient. One specimen was examined by the POC test at the clinic and the other by SDA method in the laboratory.Results:The sensitivity, specificity, positive and negative predictive values of the rapid kit were 71.4%, 99.6%, 90.9% and 98.3% respectively. Prevalence of C. trachomitis was 5.8% by SDA method.Conclusion and Global Health Implications:The kit’s sensitivity (71.4%) and specificity (99.6%) implies that the rapid test is an important test which needs further evaluations. The prevalence of C. trichomitis of 5.8% is comparable to studies done elsewhere in Africa.

Highlights

Cervical chlamydia infection poses high risk of pregnancy complications and neonatal infection
Using the Strand Displacement Amplification (SDA) reference method, 14/242 (5.8%) of the women had positive results for C. trachomatis, while 11/242 (4.6%) of the women tested positive for C. trachomatis using the rapid test method
The results of this study by the rapid (4.6%) and the reference method (5.8%) were not statistically different. This implies that the Cortez OneStep Chlamydia RapiCardTM Insta test is a valuable test for the detection of C. trachomatis in this population

Summary

Introduction

Cervical chlamydia infection poses high risk of pregnancy complications and neonatal infection. Reference methods for the detection of chlamydia infection are not available for routine use in developing countries. Up to 80% of women and 50% of men infected by C. trachomatis infections are asymptomatic, which makes clinical diagnosis of C. trachomatis infections difficult.[4] Women with cervical chlamydia infection at the time of delivery have 60-70% chance of transmitting the infection to the infant,[5] which may result in neonatal conjunctivitis in 35-50% of cases and neonatal pneumonia in 10-20% of cases.[6,7] Screening for chlamydia infection in pregnant women is, a high public health priority. Due to resource limitations in developing countries, chlamydia infection in pregnant women is not routinely screened. Diagnosis is limited to syndromic approach, a diagnostic strategy whose sensitivity and specificity are very low.[8]

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