Table 1 Characteristics of studies included in the review

Galiwango, 2014 [26]

To conduct a field evaluation assessing the accuracy of Pima

HIV infected patients (pre and experienced ART persons) at field clinics of Rakai Health Science Program in Rakai district, Southern rural Uganda. Study area has half a million population. Program is a community-based research organization with a focus on HIV/AIDS and reproductive health

Cross-sectional study

A total of 903 patients were recruited among which 258 (28.5 %) patients were on ART

Venous blood samples collected by nursing team. Data was collected for clinical purpose and analyzed anonymously

Four Pima machines were used (machines were moved to testing site, located next to clinics, everyday from central Lab)

Prior to daily testing, normal and low controls were run on each machine. Tests were run by qualified lab technicians who received Pima usage training

van Rooyen, 2013 [21]

To conduct assessment on effect of a home-based counseling and testing program that included POC CD4 testing on (1) high HIV testing coverage (2) identify newly infected or unaware HIV cases (3) reduce barriers to care and (4) increase access and adherence to ART

Known HIV-positive individuals older than 18 years in KwaZulu-Natal, South Africa. Study population characterized by high unemployment, low per capita income; and very high HIV prevalence (23.5 % among people aged ≤ 25). Study area was within walking distance of a primary health center and ART clinic

Prospective cohort study with one, three and six months follow-ups by lay counselors to evaluate outcomes

281 households enrolled, 671 adults consented and tested. Among 201 HIV infected participants, 193 had POC CD4 test in addition to CD4 lab-Cyflow.

POC CD4 testing was conducted at home using finger-prick blood sample. Venous blood samples were collected for BD FACSCalibur

Pima (as part of home-based counseling and testing program included POC CD4 testing, facilitated counseling and referrals)

POC CD4 testing was conducted in the home at the same visit when positive HIV rapid test was obtained. POC test run by lay counselor/nurse assistant; training of test operators was not reported

Mtapuri-Zinyowera, 2013 [24]

To document experience in implementation of Pima in maternal and new-born child health setting in Zimbabwe

Clients (HIV positive women, lactating mothers, their families and other users) of health facilities with high-volume ANC visits of > 100 pregnant women seen/month located in 7 districts (five in each district) in Zimbabwe with and without Pima machines

Key informants: relevant project staffs, MNCH staffs, counselors, lab staffs and ART personnel

Cross-sectional study

346 individuals were interviewed. Questionnaires were administered to 23 staff members, 62 trained POC users. Observation tools was applied to 22 trained users. Client exit questionnaire was administered to 142 clients of POC sites and 42 clients of non-POC sites. 1 client FGD conducted in each of 7 districts. Data of 207 client’s records was extracted from 45 facilities

Primary data was collected through face-to-face interviews, focus group discussion and observation using audio recorders and cameras (with verbal consent). Secondary data was extracted from medical records xxx

Pima Implemented at 35 ANC high-volume health facilities to provide CD4 count to HIV positive pregnant women and their families in hard to reach areas. Health care cadre and training of test operators not reported

Larson, 2012 [22]

To assess the impact of mobile HIV counseling and testing program on the proportion of patients completing referral visit within 8 weeks of HIV testing

Adult HIV positive patients diagnosed between May and November 2010 in a mobile HIV testing program (called ACCESS VCT) with 2 mobile units (with tents) to conduct HCT at sites (taxi rank, shopping mall) in Gauteng Province, South Africa

Retrospective cohort study

A total of 508 patients were diagnosed with 311 patients were offered POC CD4 and 197 patients were not

Data was drawn retrospectively from routinely collected medical records kept by the ACCESS VCT program and completed in Feb 2011 allow for 8 weeks follow-up for all HIV positive patients

Four Pima devices were used in the same mobile location with each assigned to one nurse. With 6–10 nurses present during the day of testing patients were randomly assigned on a first-come first-serve basis; training of test operators not reported

Glencross, 2012 [31]

To report and compare the performance of Pima in laboratory or typical South African primary health HCT clinics

Adult HIV patients attending (1) Hospital based antenatal HCT clinic in Johannesburg-phase II (2) Two Primary health care HCT clinic in Limpopo province-phase IIIA; and (3) Inner-city primary health care clinic in Johannesburg, South Africa-phase IIIB

Cross-sectional study

Phase II: N = 91

Phase IIIA: N = 96

Phase IIIB: N = 139

Both venous and capillary blood samples were collected

Pima operators (nursing personnel) were trained by the suppliers prior to commencing testing, according to methods defined by the manufacturer. Daily quality control was performed before commencing daily testing

Thakar, 2012 [25]

To assess the use of Pima at 21 ART centers in India

HIV positive patients aged 18–60 attending 21 ART centers in different parts of India having minimum (5-10/day) to moderate (25-30/day) patient load.

Cross-sectional study

Total of 1790 participants were consecutively enrolled in 21 centers (5–10 HIV positive patients from each centre)

Both venous and capillary blood samples were collected

Technologists were trained for two days for finger prick sample collection & CD4 count estimation using Pima

analyzer including the use of calibrators. Samples were run after low/normal control cartridge give acceptable values

Manabe, 2012 [27]

To evaluate performance of Pima in both laboratory and non-laboratory environment

HIV infected patients at Adult Infectious Diseases Institute Clinic within the Mulago Hospital Complex in Kampala, Uganda

Cross-sectional study

N = 206.

Both venous and finger-prick blood samples were collected by study nurse

CD4 counts were performed using 4 Pima devices. Duplicate measurements were performed on both capillary and venous samples using 2 different devices. Test operator cadre and training not stated

Jani, 2011 [28]

To assess the ability of nurse to produce accurate results with POC test in primary health care settings providing ART

Documented HIV infected individuals from general patient population attending 2 primary health care setting providing a range of health services including ART in Maputo, Mozambique

Cross-sectional study

N = 697.

Participants provided finger-prick (for POC tests) and venous blood (for lab-based tests)

Pima POC CD4 test operators were nurses in primary health clinics trained by the manufacturer. Manufacturer provided internal quality control and all POC instruments passed external qulity control assessment during study period

Mtapuri-Zinyowera, 2010 [23]

To evaluate the use of Pima and the ability of both nurses and laboratory technicians to run POC CD4 test

Newly diagnosed HIV positive patients at a VCT center at New Africa House in Harare, Zimbabwe

Cross-sectional study

N = 165.

Participants provided finger-prick (for POC tests) and venous blood (for lab-based tests).

Two Pima devices were used. Nurses and laboratory technicians equally run POC CD4 tests (50/50) on each device.

All test operators were formally trained on the Pima device and sample collection methodology for half a day

Wade, 2014 [30]

To assess performance and operational characteristics of Pima

HIV infected patients presenting for routine CD4 testing at infectious disease clinic in Dar es Salam (Tanzania)

Cross-sectional study

N = 200.

Both capillary blood (Pima) and venous blood (FACSCalibur) were collected

Pima test operator cadre and training not reported. Pima testing procedures were not described

Mwau, 2014 [7]

To evaluate the technical performance of MyT4 POC CD4 test

HIV infected patients ≥ 18 years old at comprehensive HIV care clinics of 2 health care facilities in Busia county of Western province, Kenya

Cross-sectional study

N = 276.

Finger-prick blood samples (for MyT4 test) and venous blood samples for conventional CD4 tests collected.

All samples were collected and tested using MyT4 POC CD4 by trained health care staffs (nurses and lab technicians)

Training for staff not reported

Arnett N, 2013 [29]

To assess healthcare worker acceptance and ability to perform POC CD4 test

HIV infected patients from 5 PMTCT and HIV treatment sites in Dar-es-Salaam, Tanzania

Cross-sectional study

1060 patients provided blood specimens, 11 HCWs interviewed

Each participant provided 3 samples: (1) venous (1) finger-prick directly to PIMA cartridge and (1) finger-prick collected into Microtube

Pima POC CD4 tests run by trained healthcare workers