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Table 4 Laboratory Parameters

From: Protocol for a multicenter, real-world study of HIV pre-exposure prophylaxis among men who have sex with men in China (CROPrEP)

Laboratory Parameter

Test

HIV

HIV serostatus is evaluated by ELISA (InTec Products Company, Xiamen, China), and confirmed with an HIV-1/2 western blot (HIV Blot 2.2 WBTM, Genelabs Diagnostics, Singapore). The results of anyone who screens negative for HIV will be confirmed by HIV RNA pooling PCR test (COBAS AmpliPrep /COBAS TaqMan, Roche)

HIV resistance

RNA sequencing

HIV viral load testing

COBAS AmpliPrep /COBAS TaqManv (Roche)

Syphilis

RPR (Shanghai Rongsheng, Shanghai, China) and TPPA (Fujirebio Inc., Tokyo, Japan)

Hepatitis B

HBsAg (Vitros 5600)

HSV-2

IgM-HSV-2, IgG-HSV-2 (Beier Bioengineering, Beijing, China)

Biochemistry

AST, ALT, total bilirubin, creatinine, creatinine clearance, serum phosphate, blood glucose, and lipids (Roche)

Routine blood tests

Full blood count: hemoglobin, leucocytes, platelets; differential count: absolute neutrophil count, absolute lymphocyte count (Mindray BC-5800)

Routine urine tests

Proteinuria (Mindray EH-2080)

Blood drug level testing

LC-MS (AB SCIEX API 6500+)

  1. Abbreviations: ELISA Enzyme-linked immunosorbent assay, RPR Rapid plasma reagin, TPPA Treponema pallidum particle agglutination assay, HSV-2 Herpes simplex virus 2, HBsAg Hepatitis B surface antigen, AST Aspartate transferase, ALT Alanine transferase, LC-MS Liquid chromatography-mass spectrometry