Original Article Ind. J Tub.

, 2002,49, 139

SPUTUM GRADING AS PREDICTOR OF TREATMENT

OUTCOME IN PULMONARY TUBERCULOSIS

Sanjay Rajpal1, V.K. Dhingra2 and J.K. Aggarwal3

(Original received on 13.8.01; Revised version received on 18.4.2002 ; Accepted on 7.5.2002)

Summary : A retrospective analysis of newly diagnosed sputum positive patients (Category I) registered under RNTCP in
1999 at New Delhi Tuberculosis Centre was undertaken to assess the importance of initial sputum grading as a predictor
of treatment outcome. The analysis revealed that a larger proportion of previously untreated sputum positive patients
with 3+ grading required extension of the intensive phase and had a more unfavourable treatment outcome in the form of
treatment failures and deaths than among those with a lower grading.

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INTRODUCTION smear microscopy by a specially trained laboratory

The diagnosis of pulmonary tuberculosis
under RNTCP is primarily based on sputum
examination, in accordance with the guidelines of
WHO1 and IUATLD2. All chest symptomatics are
required to get three specimens of sputum examined
by quality ZN microscopy for establishing the
diagnosis at Microscopy Centres, one for each
100,000 population. Based on the sputum results
and history of previous treatment with anti-
tuberculosis drugs, patients are categorized into the
following three categories and are treated by DOTS:
Category I - Newly diagnosed, sputum smear
positive cases, seriously ill sputum
smear negative or extra-pulmonary
cases
Category II - Sputum smear positive cases,
failure, relapse or ‘retreatment after
default’ cases
Category III - Sputum smear negative, pulmonary
or extra-pulmonary cases (not
seriously ill)
Strict quality control is maintained over
technician posted at each microscopy cum DOTS
sub-centre under the supervisory control of the
Senior Tuberculosis Laboratory Supervisor (STLS)
and District TB Centre. The results of the sputum
examination (along with the slides) are reported in a
special laboratory form in order to be noted in the
TB register kept at District TB Centre. The sputum
smears are graded, according to the number of bacilli
seen in the slide, as recommended by WHO1. It is of
interest to find out whether patients with higher
grading fare differently, as judged by treatment
results, compared to those who have lower sputum
smear grading.
OBJECTIVE
To assess the importance of initial sputum
grading as a predictor of treatment outcome.
MATERIAL AND METHODS
The New Delhi Tuberculosis Centre covers
approximately 0.4 million population residing in its
domiciliary treatment area, mainly in the congested
part of old Delhi. Four sub-centres were established,
as Microscopy-cum-DOTS Centres in the area to
provide diagnostic and treatment facility under

1. Medical Officer 2. Chest Physician 3. Director

New Delhi Tuberculosis Centre, New Delhi
Correspondence: Dr. Sanjay Rajpal, Medical Officer, New Delhi Tuberculosis Centre, Jawaharlal Nehru Marg, New Delhi 110 002

Indian Journal of Tuberculosis

140 SANJAY RAJPAL ET AL

RNTCP, in January, 1999. A specially trained under RNTCP) and their sputum grading as well as
Laboratory Technician and a Health Visitor are that of 70 patients who had extension of Intensive
posted at each sub-centre. To ensure quality sputum Phase (IP) are given in Table 1.
microscopy, the Laboratory Technician’s work is
Of the 138 patients of Category I with 3+
cross-checked by STLS. Three sputum specimens
grading, as many as 51 (36.95%) required extension
from each chest symptomatic are examined (spot,
of intensive phase, whereas only 19 of 150 patients
early morning and spot), over two consecutive days
(12.7%) having lower grades (+1 and +2 combined)
as per guidelines of RNTCP. Grading of the sputum
required an extension (χ2=23.0 for 1 d.f., p < 0.001).
smears is done according to the following table:
Table1: Distribution of all sputum positive
Result Grading No. of patients and those requiring extension
fields
of intensive phase, according to sputum
examined
More than 10 AFB grading status
per oil immersion Sputum Total patients Extension No extension
field Positive 3+ 20 grading No. (%) of IP of IP
No. (%) No. (%)
1-10 AFB per oil
immersion field Positive 2+ 50 Scanty 15 (5.2) 2 (13.3) 13 (86.7)
1+ 80 (27.7) 9 (11.2) 71 (88.8)
10-99 AFB in 100 2+ 55 (19.0) 8 (14.5) 47 (85.5)
oil immersion fields Positive 1+ 100 3+ 138 (47.9) 51 (36.9) 87 (63.1)

1-9 AFB in 100 Record Total 288 (100.0) 70 (24.3) 218 (75.7)
oil immersion fields Scanty actual 200
number Of the total 288 patients started on
treatment, 27 did not complete the treatment at the
No AFB in 100 oil Centre (6 because they were transferred out and 21
immersion fields Negative 0 100 because they defaulted in their treatment). The
treatment outcome in respect of the remaining 261
All the newly diagnosed sputum positive patients is shown in Table 2.
patients registered under RNTCP as Category I in
1999 were reviewed in detail. These patients had Table 2 : Treatment outcome of sputum positive
been given intensive phase of intermittent supervised patients who completed treatment,
chemotherapy (comprising Rifampicin, Isoniazid, according to sputum grading status
Pyrazinamide and Ethambutol) for a period of two
months. If, at the end of this period, they were still Sputum Total patients Treatment Tretament
sputum positive by direct microscopy, the intensive grading No.(%) successful failure/death
period of treatment (with same drugs) was extended No. (%) No. (%)
by one more month. Those among them, who Scanty 13 (5.0) 13 (100.0) 0 (0.0)
attained sputum conversion, were switched to a 1+ 74 (28.4) 70 (95.0) 4 (5.0)
regimen comprising Rifampicin and Isoniazid for a 2+ 54 (20.7) 53 (98.2) 1 (1.8)
further period of four months. 3+ 120 (46.0) 102 (85.0) 18 (15.0)
Total 261 (100.0) 238 (91.2) 23 (8.8)
RESULTS
In all, 18 out of 120 patients (15%) who
The total number of newly diagnosed had 3+ sputum grading had unfavourable outcome
patients with positive sputum smears (registered in the form of failure or death as compared to 5 out

Indian Journal of Tuberculosis

 SPUTUM GRADING AS PREDICTOR OF TREATMENT OUTCOME
of 141 patients (3.5%) who had lower grades (+1
and +2 combined). The difference was statistically
significant (χ2 =10.58 for 1 d.f., p < 0.01). It may
be noted that the rate of default was also higher
(11%) in 3+ patients as compared to the others (4%).
DISCUSSION
Sputum positive patients are capable of
transmitting infection and those whose sputum is
positive on direct microscopy are most likely to infect
their contacts3. By ZN staining, direct microscopy
may give a negative result if the number of acid fast
bacilli is less than 5000 bacilli/ml 4. A sputum
specimen with a concentration of 104 colony-forming
units (CFU) is more likely to result in a positive
smear5. Consistently positive specimens would have
to contain 105 bacilli per ml. varying with the extent
of the lesion or the presence of cavitation. The
number of bacilli in a medium sized cavity
communicating with bronchi is about 108(100 million)
while encapsulated nodular lesion of the same size
may have as low as 102 (100) bacilli. In an extra-
pulmonary lesion, this number is still less6. Thus,
the grading of a positive smear reflects the extent of
lesion in a particular patient or size of cavitation as
well as being directly proportional to the
infectiousness of the case. It has been shown (Table
3) that the number of bacilli in the smear is related to
the concentration of bacilli in the sputum7.
Table 3 : Number of AFB observed in smear,
concentration of CFU in specimen and
probability of positive result
No. of bacilli observed Concentration Probability of
in sputum smear of CFU in positive result
smear/ml
of sputum
0 in 100 or more fields Less than 1000 Less than 10%
1-2 in 300 fields 5000-10000 50%
1-9 in 100 fields about 30000 80%
1-9 in 10 fields about 50000 90%
1-9 per field about 100 000 96.2%
10 or more per field about 500 000 99.95%
_______________
141
The grading of a sputum smear, done by
NTA scale8 or according to the recommendations of
WHO, helps to assess the degree of infectiousness
of the patient as well as the likelihood of getting a
good treatment result.
The present study has revealed that
patients with a 3+sputum smear grading not only
require extension of treatment in the intensive
phase more often than those with scanty, 1+ or
2+ grading but also have significantly higher
failure rate. The proportion of defaulters was
also found to be higher in 3+ patients. From the
practical point of view, it would appear that
grading of sputum need not be merely an
academic exercise. It can help pinpoint a group
of patients who are likely to default oftener than
others, thus requiring a higher degree of
motivation than other patients, who may require
an extension of intensive phase of treatment
oftener and whose treatment outcome is likely
to be worse than that of others.
REFERENCES
1. World Health Organization, Treatment of Tuberculosis:
Guidelines for national programmes, 2nd ed. WHO/TB/
97.220, Geneva, 1997
2. Enarson, DA, Rieder HL, Arnadottir T, Trebucq A.
Tuberculosis Guide for Low Income Countries, 4th ed.,
Paris: International Union against Tuberculosis and Lung
Disease, 1996.
3. British Thoracic and Tuberculosis Association. A study of
standardized contact procedure in tuberculosis. Tubercle
1978; 59: 245
4. Jenkins PA. The Microbiology of Tuberculosis: Clinical
Tuberculosis, Davies PDO (ed). London, Chapman & Hall;
33
5. Allen BW, Mitchison DA. Counts of viable tubercle bacilli
in sputum related to smear and culture grading. Med Lab
Sci 1992; 49: 94
6. Toman K. Tuberculosis case finding and chemotherapy,
World Health Organization, Geneva, 1979.
7. David HL. Bacteriology of mycobacterioses. US
Department of Health, Education and Welfare, Public Health
Service, Communicable Disease Centre, Atlanta, USA, 1996.
8. National Tuberculosis and Respiratory Disease Association.
Diagnostic and Standards and Classification of Tuberculosis.
New York 1969, 41.
Indian Journal of Tuberculosis
142

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Published by the Tuberculosis Association of India in the interest of public health

Indian Journal of Tuberculosis