TABLE 1.

CLIA-waived analytes for infectious diseases^a

Analyte/method(s)	Intended use
Adenovirus antigens	Local (in tears) adenovirus detection associated with acute infectious conjunctivitis
Aerobic/anaerobic organisms—vaginal fluid	Detection of sialidase activity, an enzyme produced by bacterial pathogens such as Gardnerella vaginalis, Bacteroides spp., Prevotella spp., and Mobiluncus spp. in vaginal fluid in women suspected of having bacterial vaginosis
GAS antigen and PCR	Aid in rapid diagnosis of GAS infection of the oropharynx
Helicobacter pylori and H. pylori antibodies	Most aid in diagnosis of infection by H. pylori; some aid in presumptive identification of H. pylori in gastric biopsy specimens from patients
HCV antibody	Screen for HCV in asymptomatic, high-risk individuals
HIV antibodies; HIV-1 antibody; HIV-1 and HIV-2 antibodies; HIV-1 and HIV-2 antibodies and HIV-1 p24 antigen	Screen for HIV in asymptomatic, high-risk individuals
Infectious mononucleosis IgM heterophile antibodies	Aid in diagnosis of infectious mononucleosis
Influenza virus A and B antigens and PCR	Aid in rapid diagnosis of influenza A and B viral infections
Borrelia burgdorferi antibodies	Qualitative presumptive detection of IgG and IgM antibodies to B. burgdorferi in human serum or blood
RSV antigen and PCR	Aid in diagnosis of RSV infections in pediatric patients
Treponema pallidum antibodies	Aid in diagnosis of individuals with syphilis
Trichomonas vaginalis antigen	Qualitative detection of Trichomonas antigens in patients with symptoms or suspected exposure

^aGAS, group A Streptococcus; HCV, hepatitis C virus; HIV, human immunodeficiency virus; RSV, respiratory syncytial virus.