CAPRISA RESEARCH LABORATORY

In accordance with CLSI Approved Guideline C28-A the CAPRISA Research Laboratory will adopt the reference ranges
contained in the tables on pages 2-4 for adult and pediatric participants.

“The CLSI Approved Guideline C28-A describes different ways for a laboratory to validate the "transference" of
established reference intervals to the individual laboratory:

1. Divine judgment. The acceptability of the transfer may be subjectively assessed on the basis of consistency
between the "demographics and geographics" of the study population(s) and the demographics of the laboratory's
test population(s). The laboratory simply reviews the information submitted and subjectively verifies that the
reference intervals are applicable to the adopting laboratory's patient population and test methods. To do this, all
the information about the original study should be requested and made available to the adopting laboratory. This
includes the demographics of the reference sample group, the selection process, pre-analytical conditions of the
study such as subject preparation and specimen collection and handling techniques, the analytical system used,
and the statistical method used to establish the intervals. Sometimes it is useful to request the original reference
values and to re-analyze them to verify the original statistical analysis. Most cases for transference involve adoption
of intervals from another laboratory using the same analytical system or intervals established by the method
manufacturer.

US CLIA regulations permit the Medical Director of a laboratory to make this assessment and judgment.
While transference requires only the appropriate signature, the approach depends on a careful investigation of
published recommendations, access to appropriate information, and significance laboratory and medical experience
to assure the comparability of conditions.
Provision of reference intervals for sub-populations, particularly the pediatrics year-by-year intervals, often requires
this approach because of the difficulty in obtaining sufficient specimens to experimentally establish or verify
reference intervals.”

The adoption of these ranges is based on sound clinical judgment and consultation. The reference ranges are judged to be
representative of the South African population demographics and geographical conditions. These ranges will be monitored and
verified over time when appropriate data becomes available.

Reference Ranges 27 September 2019 Page 1 of 4

 Age Critical
Test Reference Range Source Comments
Values
TOTAL T-Cell count CD3 0-2 M 2500-5500 cells/ul NHLS Laboratory Ranges adopted without
None
verification
3M-5M 2500-5600 cells/ul None
6M-12M 1900-5900 cells/ul None
1 YEAR 2100-6200 cells/ul None
2-5 YEARS 1400-3700 cells/ul None
6-12 YEARS 1200-2600 cell/ul None
13-108 YEARS 750 – 2700 cells/ul None

CD3 % 0-2 M 53 – 84 % NHLS Laboratory Ranges adopted without

None
verification
3M-5M 51 – 77 % None
6M-12M 49 – 76 % None
1 YEAR 53 – 75 % None
2-5 YEARS 56 – 75 % None
6-12 YEARS 60 - 76 % None
13-108 YEARS 65 – 91 % None

CD4 Cell Count (Helper) 0-2 M 1600-4000 cells/ul NHLS Laboratory Ranges adopted without
None
verification
3M-5M 1800-4000 cells/ul None
6M-12M 1400-4300 cells/ul None
1 YEAR 1300-3400 cells/ul None
2-5 YEARS 700-2200 cells/ul None
6-12 YEARS 650-1500 cell/ul None
13-108 YEARS 600 – 1500 cells/ul <200 cell/ul

CD4 % 0-2 M 35 – 64 % NHLS Laboratory Ranges adopted without

None
verification
3M-5M 35 – 56 % None
6M-12M 31 – 56 % None
1 YEAR 32 – 51 % None
2-5 YEARS 28 – 47 % None
6-12 YEARS 31 - 47 % None
13-108 YEARS 30 – 60 % None

CD8 Cell Count Suppress 0-2 M 560-1700 cells/ul NHLS Laboratory Ranges adopted without
None
verification
3M-5M 590-1600 cells/ul None
6M-12M 500-1700 cells/ul None
1 YEAR 620-2000 cells/ul None
2-5 YEARS 490-1300 cells/ul None
6-12 YEARS 370-1100 cell/ul None
13-108 YEARS 400 – 1000 cells/ul None

CD 8 % 0-2 M 12 – 28 % NHLS Laboratory Ranges adopted without

None
verification
3M-5M 12 – 23 % None
6M-12M 12 – 24 % None
1 YEAR 14 – 30 % None
2-5 YEARS 16 – 30 % None
6-12 YEARS 18 - 35 % None
13-108 YEARS 22 – 51 % None

CD4:CD8 Ratio 0 M -3 YEARS 1.2 –6.2 NHLS Laboratory Ranges adopted without
None
verification
Reference Ranges 27 September 2019 Page 2 of 4
 3 Y 1 M – 12 Y 0.98 – 3.24 None
13-108 YEARS 1.0 – 2.0 None

Urinalysis Reference Critical

Range Value Source Comments
Test
Protein Negative Package insert Ranges adopted without verification

Glucose Negative Package insert Ranges adopted without verification

Blood/Haemoglobin Negative Package insert Ranges adopted without verification

Ph Measurement 5.0-8.5 Package insert Ranges adopted without verification

Micro: RBC Count <5 Package insert Ranges adopted without verification
Leucocytes <5 Package insert Ranges adopted without verification
Hyaline Casts Negative Package insert Ranges adopted without verification
Granular Casts Negative Package insert Ranges adopted without verification
Red Cell Casts Negative Package insert Ranges adopted without verification
White Cell Casts Negative Package insert Ranges adopted without verification

Nitrite Negative Package insert Ranges adopted without verification

Urobilinogen 3.2 – 131 UL/L Package insert Ranges adopted without verification

Ketones Negative Package insert Ranges adopted without verification

Specific Gravity 1.000-1.030 Package insert Ranges adopted without verification

Bilirubin Negative Package insert Ranges adopted without verification

Reference Ranges 27 September 2019 Page 3 of 4

 Limits of Critical
HIV PCR Detection Value Source Comments

ROCHE AMPLIPREP- 20 – 10 000 000 Package insert Ranges adopted without verification
TAQMAN version 2.0 cp/ml na

ABBOTT M2000 40-10 000 000 Package insert Ranges adopted without verification
cp/ml na

GENEXPERT HIV-1 20-10 000 000 Package insert Ranges adopted without verification
RNA PCR- QUANT cp/ml na

HBV DNA PCR 12 – 110 000 000 Package insert Ranges adopted without verification
na
cp/ml

Reference Range Approval

Laboratory Director: Date: 27 September 2019

Reference Ranges 27 September 2019 Page 4 of 4