Objective: This study aimed to validate the modified Faine’s criteria (Parts A and B) proposed by Brato in the early diagnosis of leptospirosis in children using the microscopic agglutination test (MAT) as gold standard. Methodology: This diagnostic validity study was conducted at the Philippine General Hospital. It included all pediatric patients who were admitted between September 2009 to December 2010 and who satisfied the presumptive and suggestive criteria in the diagnosis of leptospirosis based on the modified Faine’s criteria. A fourfold or greater rise in paired MAT titers was used as the gold standard. Calculations for sensitivity, specificity, positive and negative predictive values, and likelihood ratios of positive and negative tests were computed. Results Thirty-three patients satisfied the diagnosis of leptospirosis based on the criteria; however, only 20 of these had paired MAT titers and were included. The modified Faine’s criteria had a sensitivity of 60%, specificity of 73%, positive predictive value (PPV) of 43%, negative predictive value (NPV) of 85%, positive likelihood ratio of 2 and negative likelihood ratio of 0.4 . Modifying the clinical criteria by revision of the point allocation to create a “Pediatric Locally Modified Criteria” increased the sensitivity to 80%, PPV to 50%, NPV to 92%, positive likelihood ratio to 3 and negative likelihood ratio to 0.3. Conclusion The Modified Faine’s criteria had poor sensitivity and low positive predictive value and cannot be recommended as a screening test for the early diagnosis of leptospirosis in children. A proposed modification of the clinical criteria for local application increased diagnostic accuracy but must be further validated in a larger number of pediatric patients in the Philippines.
Leptospirosis

OBJECTIVES

To validate a method in detecting SARS-CoV-2 via RT-qPCR in pregnant and non-pregnant samples other than nasopharyngeal swabs and/or oropharyngeal swabs such as cervical, rectal, amniotic fluid, placental, umbilical cord blood, and breastmilk.

METHODS

We performed a validation experiment using MGI easy extraction kits and BGI PCR kits on non-conventional specimens, including cervical, rectal, amniotic fluid, placental, umbilical cord blood, and breastmilk to detect and confirm the presence of SARS-CoV-2. In addition, we tested the validated method on 572 purposively sampled field-collected non-conventional specimens from a cohort of 109 unvaccinated pregnant and 47 unvaccinated non-pregnant women to assess which candidate non-conventional maternal- and fetal-associated specimens may contribute to maternal-fetal viral vertical transmission.

RESULTS

Positive detection of SARS-CoV-2 viral RNA in non-conventional specimens was demonstrated and verified. Of the 572 non-conventional samples tested, 1.8% (10/572) were positively validated by RT-qPCR for SARS-CoV-2 in the maternal-associated specimens particularly the rectal (5), placental (1), and cervical (4) swabs among six pregnant and four non-pregnant individuals. In contrast, no SARS-CoV-2 viral RNA was detected in fetal-associated specimens.

CONCLUSION

The results of the validation study may serve as an additional diagnostic screening layer to support maternal-child care. Furthermore, viral detection in these non-conventional maternal specimens may also be utilized to provide guidance in the clinical management of neonates, and pregnant women during delivery.

Philippines ; Sars-cov-2 ; Pregnant Women ; Umbilical Cord ; Amniotic Fluid ; Polymerase Chain Reaction ; Placenta

Life Style ; Occupations ; Risk Factors